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Comparison of the Effectiveness of Two Different Surgical Therapeutic Protocols of Peri-implantitis

Primary Purpose

Peri-Implantitis, Peri-Implant Health

Status

Recruiting

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

Non-surgical peri-implant therapy

Implantoplasty

Erythritol Air-abrasive device

Prophylaxis

About this trial

This is an interventional treatment trial for Peri-Implantitis focused on measuring Peri-Implantitis, Surgical therapy, Implantoplasty, Air-abrasive device, Erythritol powder, Peri-Implant microbiota

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: General Inclusion Criteria: Participants ≥ 18 years and ≤ 80 years of age Non-smokers based on the patients' self-reported smoking status, defined as patients who had never smoked or had quit smoking at least 2 years ago Implants in function for more than 1 year after suprastructure connection Inclusion Criteria for implants diagnosed with Peri-Implantitis: Presence of at least one implant diagnosed with peri-implantitis defined as presence of bleeding on probing and/or suppuration, probing pocket depth ≥6 mm and ≥3 mm of detectable bone loss after initial re-modelling Absence of implant mobility in participants with more than one implant, the implant with the worst clinical condition will be studied. Inclusion Criteria for implants diagnosed with Peri-Implant Health: Absence of peri-implant signs of inflammation (redness, swelling) Lack of bleeding on probing Absence of bone loss beyond crestal bone level changes resulting from initial remodeling, which should not be ≥2 mm Exclusion Criteria: Smokers Uncontrolled diabetes mellitus (HBA1c >7) Treatment with bisphosphonates Needing antibiotic prophylaxis Currently pregnant or breast-feeding women History of systemic administration of antibiotic treatment during the preceding 3 months Systemic conditions that contraindicate treatment Use of medications known to induce gingival hyperplasia

Sites / Locations

Department of Periodontology, School of Dentistry, National and Kapodistrian University of AthensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Arm Label

Implantoplasty group

Erythritol Air-abrasive device group

Control group

Arm Description

6 weeks after completion of non-surgical peri-implant therapy, participants with peri-implant probing pocket depth ≥ 5mm and presence of bleeding on probing and/or suppuration will receive resective surgical treatment. Implantoplasty will be applied as an implant surface modification method.

6 weeks after completion of non-surgical peri-implant therapy, participants with peri-implant probing pocket depth ≥ 5mm and presence of bleeding on probing and/or suppuration will receive resective surgical treatment. Implant surface decontamination with an air-abrasive device with erythritol powder will be applied.

Participants with healthy implants will be the comparator group for the microbiological analysis.

Outcomes

Primary Outcome Measures

Treatment success as described by the composite outcome of probing pocket depth (PPD) ≤5 mm, absence of bleeding on probing (BoP) and/or suppuration and bone loss ≤0.5 mm between week 2 and 12 months post-surgery, at 12-month examination post-surgery

The percentage of treatment success will be calculated from the total amount of treated implants. PPD will be measured in mm as the distance from the mucosal peri-implant margin to the bottom of the probeable peri-implant pocket with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the targeted implants. BoP will be assessed dichotomously (1=presence, 0=absence) within 30 seconds after probing at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the targeted implants. Mean change in mm in mean marginal bone level (mesial and distal) will be assessed using an image-processing software. Standardized intra-oral radiographs will be obtained at each time point using a reproducible technique. Marginal bone level will be calculated as the distance from the implant shoulder to the most coronal bone-to-implant contact.

Mean total colony forming units (CFU) counts of the bacterial species under study in targeted implants with peri-implantitis from Baseline to Week 6 after non-surgical therapy

Mean total CFU counts from Baseline to Week 6 after non-surgical therapy will be assessed at each experimental group. Mean total CFU counts will result from microbiological analysis of subgingival samples by quantitative PCR (qPCR). Subgingival samples will be obtained with three sterile paper points from the deepest pocket of targeted implants at Baseline and at Week 6 after completion of non-surgical therapy. Detection and quantification of bacterial DNA of Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum and Campylobacter rectus will be performed.

Mean total colony forming units (CFU) counts of the bacterial species under study in targeted implants with peri-implantitis from Baseline to 12 months after surgical therapy

Mean total CFU counts from Baseline to 12 months after surgical therapy will be assessed at each experimental group. Mean total CFU counts will result from microbiological analysis of subgingival samples by quantitative PCR (qPCR). Subgingival samples will be obtained with three sterile paper points from the deepest pocket of targeted implants at Baseline, 3 months post-surgery, 6 months post-surgery and 12 months post-surgery. Detection and quantification of bacterial DNA of Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum and Campylobacter rectus will be performed.

Mean total colony forming units (CFU) counts of the bacterial species under study in targeted implants of the control group from Baseline to 12 months follow-up visit

Mean total CFU counts from Baseline to 12 months after Baseline examination will be assessed. Mean total CFU counts will result from microbiological analysis of subgingival samples by quantitative PCR (qPCR). Subgingival samples will be obtained with three sterile paper points from the implant site with the easiest access for sampling at Baseline, 3 months follow-up visit, 6 months follow-up visit, 12 months follow-up visit. Detection and quantification of bacterial DNA of Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum and Campylobacter rectus will be performed.

Secondary Outcome Measures

Mean peri-implant probing pocket depth from Baseline to Week 6 after non-surgical therapy

Mean peri-implant probing pocket depth (PPD) will be assessed at Baseline examination and Week 6 after non-surgical therapy. At each examination, PPD will be recorded at six sites per targeted implant. PPD will be measured in mm as the distance from the mucosal peri-implant margin to the bottom of the probeable peri-implant pocket with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.

Mean peri-implant probing pocket depth from Baseline to 12 months after surgical therapy

Mean peri-implant probing pocket depth (PPD) will be assessed at Baseline examination and 12 months after surgical therapy. At each examination, PPD will be recorded at six sites per targeted implant. PPD will be measured in mm as the distance from the mucosal peri-implant margin to the bottom of the probeable peri-implant pocket with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.

Mean change from Baseline in peri-implant probing pocket depth at Week 6 after non-surgical therapy

Mean change in mm in peri-implant probing pocket depth (PPD) will be assessed between Baseline examination and Week 6 after non-surgical therapy. At each examination, PPD will be recorded at six sites per targeted implant. PPD will be measured in mm as the distance from the mucosal peri-implant margin to the bottom of the probeable peri-implant pocket with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.

Mean change from Baseline in peri-implant probing pocket depth to 12 months after surgical therapy

Mean change in mm in peri-implant probing pocket depth (PPD) will be assessed between Baseline and 12 months after completion of surgical therapy. PPD will be recorded at six sites per targeted implant. PPD will be measured in mm as the distance from the mucosal peri-implant margin to the bottom of the probeable peri-implant pocket with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.

Percentage of sites with bleeding on probing from Baseline to Week 6 after non-surgical therapy

Bleeding on probing will be assessed dichotomously as present (1 for bleeding presence) or absent (0 for bleeding absence) within 30 seconds after probing. BoP will be recorded at 6 sites per targeted implants (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual)

Percentage of sites with bleeding on probing from Baseline to 12 months after surgical therapy

Change from Baseline in bleeding index score at Week 6 after completion of non-surgical therapy

Change in percentage of sites with bleeding index score (BI) from 0 to 3 will be recorded between Baseline and Week 6 after completion of non-surgical therapy. BI will be recorded at 6 sites per targeted implants (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual) within 30 seconds after probing. Bleeding will be graded as: 0= no bleeding, 1= dot of bleeding, 2= line of bleeding, 3= profuse bleeding.

Change from Baseline in bleeding index score to 12 months after surgical therapy

Change in percentage of sites with bleeding index score (BI) from 0 to 3 will be recorded between Baseline and 12 months after completion of surgical therapy. BI will be recorded at 6 sites per targeted implants (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual) within 30 seconds after probing. Bleeding will be graded as: 0= no bleeding, 1= dot of bleeding, 2= line of bleeding, 3= profuse bleeding

Percentage of sites with suppuration on probing from Baseline to Week 6 after non-surgical therapy

Suppuration on probing (SoP) will be assessed dichotomously as present (1 for suppuration presence) or absent (0 for suppuration absence) within 30 seconds after probing. SoP will be recorded at 6 sites per targeted implants (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual)

Percentage of sites with suppuration on probing from Baseline to 12 months after surgical therapy

Mean change in marginal bone level at the implant site between Week 2 after surgery and 12 months after surgery measured in intraoral radiographs

Mean change in mm between week 2 and 12 months post-surgery in mean marginal bone level (mesial and distal) will be assessed using an image-processing software. Standardized intra-oral radiographs will be obtained at Week 2 post-surgery and at 12 months post-surgery examination, using a reproducible technique with an occlusal bite index with acrylic resin mounted on a film holder. Marginal bone level will be calculated as the distance from the implant shoulder to the most coronal bone-to-implant contact, measured at the mesial and distal aspects of the studied implants at each time-point.

Mean peri-implant clinical attachment level from Baseline to Week 6 after non-surgical therapy

Mean change in mm in peri-implant clinical attachment level (CAL) will be assessed at Baseline examination and Week 6 after non-surgical therapy. CAL will be recorded at six sites per targeted implant. CAL will be measured in mm as the distance from the most apical portion of the crown or the prosthetic connection platform for removable implant-supported restorations to the bottom of the probeable peri-implant pocket with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.

Mean peri-implant clinical attachment level from Baseline to 12 months after surgical therapy

Mean change from Baseline in peri-implant clinical attachment level to Week 6 after surgical therapy

Mean change in mm in peri-implant clinical attachment level (CAL) will be assessed from Baseline examination to Week 6 after completion of surgical therapy. CAL will be recorded at six sites per targeted implant. CAL will be measured in mm as the distance from the most apical portion of the crown or the prosthetic connection platform for removable implant-supported restorations to the bottom of the probeable peri-implant pocket with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.

Mean change from Baseline in peri-implant clinical attachment level to 12 months after surgical therapy

Mean change in mm in peri-implant clinical attachment level (CAL) will be assessed from Baseline examination to 12 months after completion of surgical therapy. CAL will be recorded at six sites per targeted implant. CAL will be measured in mm as the distance from the most apical portion of the crown or the prosthetic connection platform for removable implant-supported restorations to the bottom of the probeable peri-implant pocket with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.

Mean peri-implant recession from Baseline to Week 6 after non-surgical therapy

Mean peri-implant recession (REC) in mm will be assessed at Baseline examination and Week 6 after non-surgical therapy. REC will be recorded at six sites per targeted implant. REC will be measured in mm as the distance from the free marginal mucosa to the most apical portion of the crown or the prosthetic connection platform for removable implant- supported restorations with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.

Mean peri-implant recession from Baseline to 12 months after surgical therapy

Mean peri-implant recession (REC) will be assessed in mm from Baseline examination to 12 months after surgical therapy. REC will be recorded at six sites per targeted implant. REC will be measured in mm as the distance from the free marginal mucosa to the most apical portion of the crown or the prosthetic connection platform for removable implant- supported restorations with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.

Mean change from Baseline in peri-implant recession at Week 6 after non-surgical therapy

Mean change in mm in peri-implant recession (REC) will be assessed between Baseline examination and Week 6 after non-surgical therapy. REC will be recorded at six sites per targeted implant. REC will be measured in mm as the distance from the free marginal mucosa to the most apical portion of the crown or the prosthetic connection platform for removable implant- supported restorations with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.

Mean change from Baseline in peri-implant recession to 12 months after surgical therapy

Mean change in mm in peri-implant recession (REC) will be assessed from Baseline examination to 12 months after completion of surgical therapy. REC will be recorded at six sites per targeted implant. REC will be measured in mm as the distance from the free marginal mucosa to the most apical portion of the crown or the prosthetic connection platform for removable implant- supported restorations with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the studied implant.

Mean local plaque score from Baseline to Week 6 after non-surgical therapy

Mean number of sites with plaque presence at targeted implants will be assessed between Baseline examination and Week 6 after non-surgical therapy. Local plaque score (LPS) will be calculated by assigning a binary score at each implant surface (1 for plaque presence, 0 for plaque absence) Presence or absence of plaque will be recorded at four sites per targeted implant (mesial, buccal, distal, lingual)

Mean local plaque score from Baseline to 12 months after surgical therapy

Mean number of sites with plaque presence at targeted implants will be assessed from Baseline to 12 months after completion of surgical therapy. Local plaque score (LPS) will be calculated by assigning a binary score at each surface ( 1 for plaque presence, 0 for plaque absence) and calculating the percentage of total tooth/ implant surfaces with plaque presence. Presence or absence of plaque will be recorded at 4sites per tooth/ implant (mesial, buccal, distal, lingual)

Full mouth plaque score from Baseline to Week 6 after non-surgical therapy

Percentage of full mouth plaque score (FMPS) presence from Baseline to Week 6 after completion of non-surgical therapy. FMPS will be calculated by assigning a binary score at each surface ( 1 for plaque presence, 0 for plaque absence) and calculating the percentage of total tooth/ implant surfaces with plaque presence. Presence or absence of plaque will be recorded at four sites per tooth/ implant (mesial, buccal, distal, lingual)

Full mouth plaque score from Baseline to 12 months after surgical therapy

Percentage of full mouth plaque score (FMPS) presence from Baseline to 12 months after completion of surgical therapy. FMPS will be calculated by assigning a binary score at each surface ( 1 for plaque presence, 0 for plaque absence) and calculating the percentage of total tooth/ implant surfaces with plaque presence. Presence or absence of plaque will be recorded at 4sites per tooth/ implant (mesial, buccal, distal, lingual)

Full mouth bleeding score from Baseline to Week 6 after non-surgical therapy

Percentage of full mouth bleeding score (FMBS) presence from Baseline to Week 6 after completion of non-surgical therapy. FMBS will be calculated by assigning a binary score at each surface ( 1 for bleeding presence, 0 for bleeding absence) within 30 seconds after probing and calculating the percentage of total tooth/ implant surfaces that bled upon probing. Presence or absence of bleeding will be recorded at six sites per tooth/ implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual)

Full mouth bleeding score from Baseline to 12 months after surgical therapy

Percentage of full mouth bleeding score (FMBS) presence from Baseline to 12 months after completion of surgical therapy. FMBS will be calculated by assigning a binary score at each surface ( 1 for bleeding presence, 0 for bleeding absence) within 30 seconds after probing and calculating the percentage of total tooth/ implant surfaces that bled upon probing. Presence or absence of bleeding will be recorded at 6 sites per tooth/ implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual)

Evaluation of participants' pain on the visual analogue scale (VAS, 10cm) at Week 2 post-surgery

Participants will complete a questionnaire at Week 2 post-surgery in order to assess the intensity of post-surgical pain using a visual analogue scale (VAS, 10cm). The following question will be asked: -From 0-10, rate the intensity of pain after surgery in the treated areas. (0 represents "no pain" and 10 represents "unbearable pain").

Evaluation of participants' pain on the visual analogue scale (VAS, 10cm) at 12 months post-surgery

Participants will complete a questionnaire at 12 months post-surgery in order to assess the intensity of pain at the treated sites at 12 months after surgery using a visual analogue scale (VAS, 10cm). The following question will be asked: From 0-10, rate the intensity of pain after surgery in the treated areas. (0 represents "no pain" and 10 represents "unbearable pain").

Evaluation of participants' pain during toothbrushing on the visual analogue scale (VAS, 10cm) at 12 months post-surgery

Participants will complete a questionnaire at 12 months post-surgery in order to assess the intensity of pain during toothbrushing at the treated sites at 12 months after surgery using a visual analogue scale (VAS, 10cm). The following question will be asked: From 0-10, rate the intensity of pain after surgery in the treated areas. (0 represents "no pain" and 10 represents "unbearable pain").

Evaluation of participants' swelling on the visual analogue scale (VAS) at Week 2 post-surgery

Participants will complete a questionnaire at Week 2 post-surgery in order to assess the intensity of post-surgical swelling using a visual analogue scale (VAS, 10cm). The following question will be asked: -From 0-10 rate the amount of post-surgery swelling in the treated areas. (0 represents "no swelling" and 10 "maximum swelling").

Evaluation of participants' bleeding tendency when applying oral hygiene on the visual analogue scale (VAS, 10cm) at 12 months post-surgery

Participants will complete a questionnaire at 12 months post-surgery in order to assess the intensity of bleeding during toothbrushing or interdental cleaning at the treated sites at 12 months after surgery using a visual analogue scale (VAS, 10cm). The following question will be asked: assess the presence and intensity of pain during toothbrushing at the treated sites at 12 months after surgery using a visual analogue scale (VAS, 10cm). The following question will be asked: -From 0-10 rate the amount of bleeding when applying oral hygiene to the areas you treated. (0 represents "no bleeding" and 10 "maximum bleeding").

Number of days of analgesic consumption at Week 2 post-surgery

Participants will complete a questionnaire at Week 2 post-surgery in order to record the number of days analgesics were needed .

Evaluation of patients' satisfaction on the visual analogue scale (VAS) at Week 2 post-surgery

Participants will complete a questionnaire at Week 2 post-surgery in order to assess satisfaction with the treatment provided using a visual analogue scale (VAS, 10cm). The followed questions will be asked: -If necessary, would you do this treatment again? (0 represents aversion to repeating the treatment and 10 that you would repeat it comfortably).

Evaluation of patients' willingness to recommend the treatment on the visual analogue scale (VAS) at Week 2 post-surgery

Participants will complete a questionnaire at Week 2 post-surgery in order to assess satisfaction with the treatment provided using a visual analogue scale (VAS, 10cm). The followed questions will be asked: -Would you recommend the treatment to a relative or friend? (0 represents that you would not recommend it under any circumstances and 10 that you would absolutely recommend it, if necessary).

Evaluation of patients' satisfaction on the visual analogue scale (VAS) at 12 months post-surgery

Participants will complete a questionnaire at 12 months post-surgery in order to assess satisfaction with the treatment provided using a visual analogue scale (VAS, 10cm). The followed questions will be asked: -Are you satisfied with the treatment you received? (0 represents "not at all satisfied" and 10 "completely satisfied").

Evaluation of patients' willingness to recommend the treatment on the visual analogue scale (VAS) at 12 months post-surgery

Participants will complete a questionnaire at 12 months post-surgery in order to assess satisfaction with the treatment provided using a visual analogue scale (VAS, 10cm). The followed questions will be asked: -Would you recommend the treatment to a relative or friend? (0 represents that you would not recommend it under any circumstances and 10 that you would absolutely recommend it, if necessary).

Full Information

NCT ID

NCT05899933

First Posted

June 2, 2023

Last Updated

July 27, 2023

Sponsor

National and Kapodistrian University of Athens

1. Study Identification

Unique Protocol Identification Number

NCT05899933

Brief Title

Comparison of the Effectiveness of Two Different Surgical Therapeutic Protocols of Peri-implantitis

Official Title

Implantoplasty Versus Implant Decontamination With Erythritol Air-abrasive Device During Surgical Therapy of Peri-implantitis. Clinical, Radiographic and Microbiological Evaluation. A Randomized Controlled Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 28, 2023 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National and Kapodistrian University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of the present study is to compare the 1-year clinical, radiographic and microbiological outcomes and patients' satisfaction following surgical treatment of peri-implantitis after applying two different surface modification methods. Secondarily, analysis and comparison of the microbiological results of implants diagnosed and treated for peri-implantitis with healthy implants will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peri-Implantitis, Peri-Implant Health

Keywords

Peri-Implantitis, Surgical therapy, Implantoplasty, Air-abrasive device, Erythritol powder, Peri-Implant microbiota

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The experimental protocol is designed as a double-blind, randomized clinical trial with a 12-month duration and a parallel design

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Implantoplasty group

Arm Type

Experimental

Arm Description

Arm Title

Erythritol Air-abrasive device group

Arm Type

Experimental

Arm Description

6 weeks after completion of non-surgical peri-implant therapy, participants with peri-implant probing pocket depth ≥ 5mm and presence of bleeding on probing and/or suppuration will receive resective surgical treatment. Implant surface decontamination with an air-abrasive device with erythritol powder will be applied.

Arm Title

Control group

Arm Type

Other

Arm Description

Participants with healthy implants will be the comparator group for the microbiological analysis.

Intervention Type

Procedure

Intervention Name(s)

Non-surgical peri-implant therapy

Intervention Description

2 weeks after baseline examination, non surgical therapy will be applied in implants diagnosed with peri-implantitis prior to enrollment in surgical therapy. Firstly, participants will be instructed in oral hygiene. Professional supragingival and subgingival debridement of implants/ teeth, including the selected for the study implants, will be performed. Local anesthesia will be performed, when needed. Targeted implants will be treated with PEEK-coating ultrasonic tips (Instrument PI; EMS), titanium curettes (IMPM11/12T, IMPM13/14T; Hu-Friedy), rubber cup and polishing paste. Possible adjustments to implant-borne prostheses will be considered, whenever possible. Re-evaluation of non-surgical therapy will be performed after 6 weeks. At the 6-week reevaluation, participants with peri-implant probing pocket depth ≥5 mm and bleeding on probing and/or suppuration in patients with full mouth plaque score ≤20% will proceed to surgical therapy.

Intervention Type

Procedure

Intervention Name(s)

Implantoplasty

Intervention Description

Screw-retained supraconstructions and, when possible, cement-retained restorations will be removed. Following local anesthesia, intrasulcular incisions will be performed and full-thickness flaps will be elevated on the buccal and lingual aspects of affected implants. Granulation tissue will be removed, and titanium-coated curettes (IMPM11/12T, IMPM13/14T; Hu-Friedy) and NiTi brushes (NEGRIN IN DENTAL) will be applied to remove hard deposits on implants. Osseous recontouring will be performed when indicated followed by irrigations with saline. Implantoplasty will be applied using tungsten carbide burs of various shapes and sizes (Peri-implantitis Kit; Meisinger) followed by irrigations with saline. Flaps will be readjusted and closed with sutures in order to allow a non-submerged healing. Supraconstructions will be reconnected after the surgery.

Intervention Type

Procedure

Intervention Name(s)

Erythritol Air-abrasive device

Intervention Description

Screw-retained supraconstructions and, when possible, cement-retained restorations will be removed. Following local anesthesia, intrasulcular incisions will be performed and full-thickness flaps will be elevated on the buccal and lingual aspects of affected implants. Granulation tissue will be removed, and titanium-coated curettes (IMPM11/12T, IMPM13/14T; Hu-Friedy), and NiTi brushes (NEGRIN IN DENTAL) will be applied to remove hard deposits on implants. Osseous recontouring will be performed when indicated followed by irrigations with saline. Implant surface decontamination with an air-abrasive device (AIRFLOW® MAX, AIRFLOW® Prophylaxis Master; EMS) with erythritol powder (AIRFLOW® Plus Powder; EMS) will be applied followed by irrigations with saline. Flaps will be readjusted and closed with sutures in order to allow a non-submerged healing. Supraconstructions will be reconnected after the surgery.

Intervention Type

Procedure

Intervention Name(s)

Prophylaxis

Intervention Description

Supramucosal biofilm removal of implants/ teeth will be performed at, 3, 6, 9 and 12 months after surgical therapy for the Implantoplasty group and the Erythritol Air-abrasive device group and at 2 weeks, 3, 6, 9 and 12 months after baseline examination for the control group. Targeted implants will be treated with an air-abrasive device (AIRFLOW® MAX, AIRFLOW® Prophylaxis Master; EMS) with erythritol powder (AIRFLOW® Plus Powder; EMS). During these appointments, patients will be re-motivated and re-instructed to oral-hygiene measures.

Primary Outcome Measure Information:

Title

Description

Time Frame

12 months post-surgery

Title

Mean total colony forming units (CFU) counts of the bacterial species under study in targeted implants with peri-implantitis from Baseline to Week 6 after non-surgical therapy

Description

Time Frame

Baseline, Week 6 after non-surgical therapy

Title

Mean total colony forming units (CFU) counts of the bacterial species under study in targeted implants with peri-implantitis from Baseline to 12 months after surgical therapy

Description

Time Frame

Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery

Title

Mean total colony forming units (CFU) counts of the bacterial species under study in targeted implants of the control group from Baseline to 12 months follow-up visit

Description

Time Frame

Baseline, 3 months follow-up visit, 6 months follow-up visit, 12 months follow-up visit

Secondary Outcome Measure Information:

Title

Mean peri-implant probing pocket depth from Baseline to Week 6 after non-surgical therapy

Description

Time Frame

Baseline, Week 6 after non-surgical therapy

Title

Mean peri-implant probing pocket depth from Baseline to 12 months after surgical therapy

Description

Time Frame

Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery

Title

Mean change from Baseline in peri-implant probing pocket depth at Week 6 after non-surgical therapy

Description

Time Frame

Baseline, Week 6 after non-surgical therapy

Title

Mean change from Baseline in peri-implant probing pocket depth to 12 months after surgical therapy

Description

Time Frame

Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery

Title

Percentage of sites with bleeding on probing from Baseline to Week 6 after non-surgical therapy

Description

Time Frame

Baseline, Week 6 after non-surgical therapy

Title

Percentage of sites with bleeding on probing from Baseline to 12 months after surgical therapy

Description

Time Frame

Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery

Title

Change from Baseline in bleeding index score at Week 6 after completion of non-surgical therapy

Description

Time Frame

Baseline, Week 6 after non-surgical therapy

Title

Change from Baseline in bleeding index score to 12 months after surgical therapy

Description

Time Frame

Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery

Title

Percentage of sites with suppuration on probing from Baseline to Week 6 after non-surgical therapy

Description

Time Frame

Baseline, Week 6 after non-surgical therapy

Title

Percentage of sites with suppuration on probing from Baseline to 12 months after surgical therapy

Description

Time Frame

Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery

Title

Mean change in marginal bone level at the implant site between Week 2 after surgery and 12 months after surgery measured in intraoral radiographs

Description

Time Frame

Week 2 post-surgery, 12 months post-surgery

Title

Mean peri-implant clinical attachment level from Baseline to Week 6 after non-surgical therapy

Description

Time Frame

Baseline, Week 6 after non-surgical therapy

Title

Mean peri-implant clinical attachment level from Baseline to 12 months after surgical therapy

Description

Time Frame

Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery

Title

Mean change from Baseline in peri-implant clinical attachment level to Week 6 after surgical therapy

Description

Time Frame

Baseline, Week 6 after non-surgical therapy

Title

Mean change from Baseline in peri-implant clinical attachment level to 12 months after surgical therapy

Description

Time Frame

Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery

Title

Mean peri-implant recession from Baseline to Week 6 after non-surgical therapy

Description

Time Frame

Baseline, Week 6 after non-surgical therapy

Title

Mean peri-implant recession from Baseline to 12 months after surgical therapy

Description

Time Frame

Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery

Title

Mean change from Baseline in peri-implant recession at Week 6 after non-surgical therapy

Description

Time Frame

Baseline, Week 6 after non-surgical therapy

Title

Mean change from Baseline in peri-implant recession to 12 months after surgical therapy

Description

Time Frame

Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery

Title

Mean local plaque score from Baseline to Week 6 after non-surgical therapy

Description

Time Frame

Baseline, Week 6 after non-surgical therapy

Title

Mean local plaque score from Baseline to 12 months after surgical therapy

Description

Time Frame

Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery

Title

Full mouth plaque score from Baseline to Week 6 after non-surgical therapy

Description

Time Frame

Baseline, Week 6 after non-surgical therapy

Title

Full mouth plaque score from Baseline to 12 months after surgical therapy

Description

Time Frame

Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery

Title

Full mouth bleeding score from Baseline to Week 6 after non-surgical therapy

Description

Time Frame

Baseline, Week 6 after non-surgical therapy

Title

Full mouth bleeding score from Baseline to 12 months after surgical therapy

Description

Time Frame

Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery

Title

Evaluation of participants' pain on the visual analogue scale (VAS, 10cm) at Week 2 post-surgery

Description

Time Frame

Week 2 post-surgery

Title

Evaluation of participants' pain on the visual analogue scale (VAS, 10cm) at 12 months post-surgery

Description

Time Frame

12 months post-surgery

Title

Evaluation of participants' pain during toothbrushing on the visual analogue scale (VAS, 10cm) at 12 months post-surgery

Description

Time Frame

12 months post-surgery

Title

Evaluation of participants' swelling on the visual analogue scale (VAS) at Week 2 post-surgery

Description

Time Frame

Week 2 post-surgery

Title

Evaluation of participants' bleeding tendency when applying oral hygiene on the visual analogue scale (VAS, 10cm) at 12 months post-surgery

Description

Time Frame

12 months post-surgery

Title

Number of days of analgesic consumption at Week 2 post-surgery

Description

Participants will complete a questionnaire at Week 2 post-surgery in order to record the number of days analgesics were needed .

Time Frame

Week 2 post-surgery

Title

Evaluation of patients' satisfaction on the visual analogue scale (VAS) at Week 2 post-surgery

Description

Time Frame

Week 2 post-surgery

Title

Evaluation of patients' willingness to recommend the treatment on the visual analogue scale (VAS) at Week 2 post-surgery

Description

Participants will complete a questionnaire at Week 2 post-surgery in order to assess satisfaction with the treatment provided using a visual analogue scale (VAS, 10cm). The followed questions will be asked: -Would you recommend the treatment to a relative or friend? (0 represents that you would not recommend it under any circumstances and 10 that you would absolutely recommend it, if necessary).

Time Frame

Week 2 post-surgery

Title

Evaluation of patients' satisfaction on the visual analogue scale (VAS) at 12 months post-surgery

Description

Time Frame

12 months post-surgery

Title

Evaluation of patients' willingness to recommend the treatment on the visual analogue scale (VAS) at 12 months post-surgery

Description

Participants will complete a questionnaire at 12 months post-surgery in order to assess satisfaction with the treatment provided using a visual analogue scale (VAS, 10cm). The followed questions will be asked: -Would you recommend the treatment to a relative or friend? (0 represents that you would not recommend it under any circumstances and 10 that you would absolutely recommend it, if necessary).

Time Frame

12 months post-surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yiorgos A. Bobetsis, Assistant Professor

Phone

(+30) 210-746-1097

ybobetsi@dent.uoa.gr

First Name & Middle Initial & Last Name or Official Title & Degree

Sotiria Tsantila

soteriatsantila@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Phoebus N. Madianos

Organizational Affiliation

National and Kapodistrian University of Athens

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Periodontology, School of Dentistry, National and Kapodistrian University of Athens

City

Athens

ZIP/Postal Code

11527

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yiorgos A. Bobetsis

Phone

210-746-1097

Ext

+30

ybobetsi@dent.uoa.gr

First Name & Middle Initial & Last Name & Degree

Sotiria Tsantila

Phone

6975661234

Ext

+30

soteriatsantila@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The data that supports the findings of this study will be available from the corresponding author upon reasonable request.

IPD Sharing Time Frame

Data requests will be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered.

IPD Sharing Access Criteria

Access to trial individual participant data (IPD) can be requested by qualified investigators whose proposed research has received Institutional Review Board (IRB) approval. Data will be available via a data repository following execution of data use agreement.

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Learn more about this trial

Comparison of the Effectiveness of Two Different Surgical Therapeutic Protocols of Peri-implantitis

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