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Non-surgical Electrolytic Cleaning Peri-implantitis

Primary Purpose

Peri-Implantitis

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Implant hygiene instructions and removal of the prosthesis

Non-surgical peri-implantitis treatment /microsurgery

Implant surface decontamination 1(ultrasonic device)

Implant surface decontamination 2 (air polishing)

Implant surface decontamination 3 (electrolytic cleaning)

Antibiotic treatment (Metronidazole)

Modification and polishing of the prosthesis

About this trial

This is an interventional treatment trial for Peri-Implantitis focused on measuring Peri-implantitis, Electrolytic cleaning, Implant decontamination, Non-surgical treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female age > 18 years.
Presence of at least 1 implant with the diagnose of peri-implantitis (Berglundh et al. 2018; Renvert et al. 2018)
Peri-implant bone loss < 2/3
History of treated periodontal diseases (Caton 2018).
Screw retained prosthesis that can be easily unscrewed.
Prosthesis that allows access to biofilm control by the patient, or which can be modified accordingly.
Absence of implant mobility

Exclusion Criteria:

Systemic exclusion criteria

Pregnant or lactating women Non-surgical electrolytic cleaning CONFIDENTIAL
Patients chronically treated (i.e., two weeks or more) with any medication known to affect periodontal/peri-implant status (i.e., antibiotics intake within 3 months prior to the initiation)
Medical conditions requiring prolonged use of steroids and/or with medications that could interfere with bone metabolism.
History of leukocyte dysfunction and deficiencies.
History of neoplastic disease requiring the use of radiation or chemotherapy.
Patients with chronic renal failure requiring dialysis.
Patients with metabolic bone disorders such as osteoporosis treated with antiresoptive medications.
History of uncontrolled endocrine disorders: hypothyroidism or diabetes.
Physical handicaps that would interfere with the ability to perform adequate oral hygiene or patients unable to use daily interproximal cleaning.
Alcoholism or drug abuse.
History of immunodeficiency syndromes.
Tobacco consumption (smoking more than 10 cigarettes per day)
Conditions or circumstances, which in the opinion of the investigator, would avoid the completion of study participation, or interfere with analysis of study results, such as history of non-compliance or unreliability, or do have any additional medical condition that contraindicates non-surgical treatment

Local exclusion criteria

Mucosal diseases such as erosive lichen planus in the area to be treated.
History of local irradiation therapy.
Implants with peri-implant bone loss beyond 2/3 of the implant length

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Non-surgical electrolytic cleaning

Arm Description

Implant hygiene instructions and removal of the prosthesis Local anaesthesia Removal of the granulation tissue and mucosa and bone defect curettage with a steel curette 4R/4L (Hu-Friedy, Chicago, IL, USA) Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss). Erythritol air powder-spray system (Air-flow ® master piezon, EMS, Nyon swiss) implant surface treatment. This will be performed by separating the soft tissue with the aim of a periodontal probe (CP 15, Hu-Friedy, Chicago, IL, USA). Electrolytic cleaning of the implant surface following manufacturer's instructions (GalvoSurge Dental AG, Widnau, Switzerland), with the help of a non-metal periodontal probe to separate the soft tissues and aim the implant surface in all its length. Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day). If necessary, modification and polishing of the prosthesis to make it cleanable.

Outcomes

Primary Outcome Measures

Peri-implant disease resolution at 6 month

Probing depth < 5 mm, with absence of bleeding or suppuration and no additional bone loss (Sanz & Chapple 2012)

Peri-implant disease resolution at 12 month

Probing depth < 5 mm, with absence of bleeding or suppuration and no additional

Secondary Outcome Measures

Implant survival rate at 6 months

Survival of installed implants as defined by Misch et al., 2007: presence in the mouth, no mobility, no pain upon function, radiographic bone loss less than 1⁄2, no uncontrolled infection.

Implant survival rate at 12 months

Survival of installed implants as defined by Misch et al., 2007: presence in the mouth, no mobility, no pain upon function, radiographic bone loss less than 1⁄2, no uncontrolled infection.

Implant plaque index at 6 months

Implant plaque index (PI) (at 6 sites/implant)(+/-).

Implant plaque index at 12 months

Implant plaque index (PI) (at 6 sites/implant)(+/-).

Peri-implant probing depth at 6 months

Peri-implant probing depth (PD) (at 6 sites/implant) recorded using a CPC-15 periodontal probe at 6 sites/implant (Hu-Friedy, Leinmen, Germany).

Peri-implant probing depth at 12 months

Peri-implant probing depth (PD) (at 6 sites/implant) recorded using a CPC-15 periodontal probe at 6 sites/implant (Hu-Friedy, Leinmen, Germany).

Bleeding on probing at 6 months

Bleeding on probing (BOP) from the peri-implant mucosa (measured at 6 sites/implant) (+/-).

Bleeding on probing at 12 months

Bleeding on probing (BOP) from the peri-implant mucosa (measured at 6 sites/implant) (+/-).

Suppuration at 6 months

Presence or absence of suppuration from the peri-implant mucosa (measured at 6 sites/implant) (+/-) nice, regular, unpleasant, very unpleasant).

Suppuration at 12 months

Presence or absence of suppuration from the peri-implant mucosa (measured at 6 sites/implant) (+/-)

Recession of the mucosal margin at 6 months

Recession of the mucosal margin, keratinized mucosa (at 6 sites/implant) (+/-).recorded using a CPC-15 periodontal probe at 6 sites/implant (Hu-Friedy, Leinmen, Germany).

Recession of the mucosal margin at 12 months

Recession of the mucosal margin, keratinized mucosa (at 6 sites/implant) (+/-).recorded using a CPC-15 periodontal probe at 6 sites/implant (Hu-Friedy, Leinmen, Germany).

Bone loss at 6 months

Distance between bone crest and implant shoulder at mesial and distal site. For standardization of the periapical radiographs the same film holder-beam aiming device will be applied to each treated implant (i.e. Rinn System, RWT window x-ray system or Non-surgical electrolytic cleaning CONFIDENTIAL similar). The radiographs will be taken with the film placed parallel to the implants and the x-ray beam directed perpendicular to the implants. The quality/contrast should be good enough to clearly identify the complete implant and its essential structures. Digital radiographs will be evaluated using a software (OsiriX Imaging Software, Pixmeo, Geneva, Switzerland) calibrating the distances with implant wide and length.

Bone loss at 12 months

Patient centred outcomes of the electrolytic cleaning after 6 months

Patient centred outcomes of the electrolytic cleaning with a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).

Patient centred outcomes of the electrolytic cleaning after 12 months

Patient centred outcomes of the electrolytic cleaning with a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).

Overall satisfaction after 6 months

Overall satisfaction on a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).

Overall satisfaction after 12 months

Overall satisfaction on a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).

Full Information

NCT ID

NCT05275894

First Posted

February 2, 2022

Last Updated

June 8, 2022

Sponsor

Universidad Complutense de Madrid

1. Study Identification

Unique Protocol Identification Number

NCT05275894

Brief Title

Non-surgical Electrolytic Cleaning Peri-implantitis

Official Title

Non-surgical Treatment of Peri-implantitis With Electrolytic Cleaning: a Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 15, 2022 (Anticipated)

Primary Completion Date

July 30, 2023 (Anticipated)

Study Completion Date

July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis. A prospective clinical and radiographic case series study will be performed to evaluate the clinical performance of the adjunctive use of electrolytic cleaning as an adjunct to a non-surgical therapy protocol that includes curettage of the peri-implant soft tissue. This is study is a proof of principle study, thus, a case series study is selected to start with. If the results of this case series study are favourable, a future study with a clinical trial design is then planned to do.

Detailed Description

Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis. Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis.This is study is a proof of principle study, thus, a case series study is selected to start with. As this is a pilot study to test for the first time the electrolytic cleaning under non-surgical therapy, the sample size has been estimated in a minimum of 25 patients. If the results of this case series study are favourable, a future study with a clinical trial design is then planned to do. Therapeutic success is defined as as a composite index (Sanz & Chapple 2012 criteria of disease resolution) that includes: (1) probing pocket depth < 5 mm, (2) no bleeding on probing/suppuration and (3) no additional bone loss, at 6 and 12 months). Secondary objectives are: Changes in the clinical outcomes measurements.Changes in the radiological outcomes measurements. Changes in the patient-reported outcomes (PROMs). Evaluation of the outcomes related to the prosthetic restoration. This study will be carried out in the following centers: Postgraduate Periodontal Clinic at the Faculty of Odontology-Universidad Complutense of Madrid (Spain) CEOSA-Madrid Private Dental Centre After the non-surgical therapy, patients will be recalled for control visits, with supra- gingival removal of biofilm with air polishing without anaesthesia at: 3 months. 6 months. 12 months. After non-surgical therapy, patients will be included in a strict peri-implant maintenance therapy program to avoid re-contamination of the affected implants. Removal of biofilm with air polishing without anaesthesia and oral hygiene instruction reinforcement will be performed at: 3 months, 6 months, 9 months and 12 months.

6. Conditions and Keywords

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

Peri-Implantitis

Keywords

Peri-implantitis, Electrolytic cleaning, Implant decontamination, Non-surgical treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Non-surgical electrolytic cleaning

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Implant hygiene instructions and removal of the prosthesis

Intervention Description

Verbal instructions on implant hygiene practices and removal of the implant supported prosthesis

Intervention Type

Procedure

Intervention Name(s)

Non-surgical peri-implantitis treatment /microsurgery

Intervention Description

Removal of the granulation tissue and mucosa and bone defect curettage with a steel curette 4R/4L (Hu-Friedy, Chicago, IL, USA) after applying local anestesia

Intervention Type

Procedure

Intervention Name(s)

Implant surface decontamination 1(ultrasonic device)

Intervention Description

Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss).

Intervention Type

Procedure

Intervention Name(s)

Implant surface decontamination 2 (air polishing)

Intervention Description

Erythritol air powder-spray system (Air-flow ® master piezon, EMS, Nyon swiss) implant surface treatment. This will be performed by separating the soft tissue with the aim of a periodontal probe (CP 15, Hu-Friedy, Chicago, IL, USA).

Intervention Type

Procedure

Intervention Name(s)

Implant surface decontamination 3 (electrolytic cleaning)

Intervention Description

Electrolytic cleaning of the implant surface following manufacturer's instructions (GalvoSurge Dental AG, Widnau, Switzerland), with the help of a non-metal periodontal probe to separate the soft tissues and aim the implant surface in all its length.

Intervention Type

Drug

Intervention Name(s)

Antibiotic treatment (Metronidazole)

Other Intervention Name(s)

Metronidazole

Intervention Description

Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day).

Intervention Type

Procedure

Intervention Name(s)

Modification and polishing of the prosthesis

Intervention Description

If necessary, modification and polishing of the prosthesis to make it cleanable.

Primary Outcome Measure Information:

Title

Peri-implant disease resolution at 6 month

Description

Probing depth < 5 mm, with absence of bleeding or suppuration and no additional bone loss (Sanz & Chapple 2012)

Time Frame

6 months

Title

Peri-implant disease resolution at 12 month

Description

Probing depth < 5 mm, with absence of bleeding or suppuration and no additional

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Implant survival rate at 6 months

Description

Survival of installed implants as defined by Misch et al., 2007: presence in the mouth, no mobility, no pain upon function, radiographic bone loss less than 1⁄2, no uncontrolled infection.

Time Frame

6 months

Title

Implant survival rate at 12 months

Description

Survival of installed implants as defined by Misch et al., 2007: presence in the mouth, no mobility, no pain upon function, radiographic bone loss less than 1⁄2, no uncontrolled infection.

Time Frame

12 months

Title

Implant plaque index at 6 months

Description

Implant plaque index (PI) (at 6 sites/implant)(+/-).

Time Frame

6 months

Title

Implant plaque index at 12 months

Description

Implant plaque index (PI) (at 6 sites/implant)(+/-).

Time Frame

12 months

Title

Peri-implant probing depth at 6 months

Description

Peri-implant probing depth (PD) (at 6 sites/implant) recorded using a CPC-15 periodontal probe at 6 sites/implant (Hu-Friedy, Leinmen, Germany).

Time Frame

6 months

Title

Peri-implant probing depth at 12 months

Description

Peri-implant probing depth (PD) (at 6 sites/implant) recorded using a CPC-15 periodontal probe at 6 sites/implant (Hu-Friedy, Leinmen, Germany).

Time Frame

12 months

Title

Bleeding on probing at 6 months

Description

Bleeding on probing (BOP) from the peri-implant mucosa (measured at 6 sites/implant) (+/-).

Time Frame

6 months

Title

Bleeding on probing at 12 months

Description

Bleeding on probing (BOP) from the peri-implant mucosa (measured at 6 sites/implant) (+/-).

Time Frame

12 months

Title

Suppuration at 6 months

Description

Presence or absence of suppuration from the peri-implant mucosa (measured at 6 sites/implant) (+/-) nice, regular, unpleasant, very unpleasant).

Time Frame

6 months

Title

Suppuration at 12 months

Description

Presence or absence of suppuration from the peri-implant mucosa (measured at 6 sites/implant) (+/-)

Time Frame

12 months

Title

Recession of the mucosal margin at 6 months

Description

Recession of the mucosal margin, keratinized mucosa (at 6 sites/implant) (+/-).recorded using a CPC-15 periodontal probe at 6 sites/implant (Hu-Friedy, Leinmen, Germany).

Time Frame

6 months

Title

Recession of the mucosal margin at 12 months

Description

Recession of the mucosal margin, keratinized mucosa (at 6 sites/implant) (+/-).recorded using a CPC-15 periodontal probe at 6 sites/implant (Hu-Friedy, Leinmen, Germany).

Time Frame

12 months

Title

Bone loss at 6 months

Description

Time Frame

6 months

Title

Bone loss at 12 months

Description

Time Frame

12 months

Title

Patient centred outcomes of the electrolytic cleaning after 6 months

Description

Patient centred outcomes of the electrolytic cleaning with a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).

Time Frame

6 months

Title

Patient centred outcomes of the electrolytic cleaning after 12 months

Description

Patient centred outcomes of the electrolytic cleaning with a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).

Time Frame

12 months

Title

Overall satisfaction after 6 months

Description

Overall satisfaction on a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).

Time Frame

6 months

Title

Overall satisfaction after 12 months

Description

Overall satisfaction on a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female age > 18 years. Presence of at least 1 implant with the diagnose of peri-implantitis (Berglundh et al. 2018; Renvert et al. 2018) Peri-implant bone loss < 2/3 History of treated periodontal diseases (Caton 2018). Screw retained prosthesis that can be easily unscrewed. Prosthesis that allows access to biofilm control by the patient, or which can be modified accordingly. Absence of implant mobility Exclusion Criteria: Systemic exclusion criteria Pregnant or lactating women Non-surgical electrolytic cleaning CONFIDENTIAL Patients chronically treated (i.e., two weeks or more) with any medication known to affect periodontal/peri-implant status (i.e., antibiotics intake within 3 months prior to the initiation) Medical conditions requiring prolonged use of steroids and/or with medications that could interfere with bone metabolism. History of leukocyte dysfunction and deficiencies. History of neoplastic disease requiring the use of radiation or chemotherapy. Patients with chronic renal failure requiring dialysis. Patients with metabolic bone disorders such as osteoporosis treated with antiresoptive medications. History of uncontrolled endocrine disorders: hypothyroidism or diabetes. Physical handicaps that would interfere with the ability to perform adequate oral hygiene or patients unable to use daily interproximal cleaning. Alcoholism or drug abuse. History of immunodeficiency syndromes. Tobacco consumption (smoking more than 10 cigarettes per day) Conditions or circumstances, which in the opinion of the investigator, would avoid the completion of study participation, or interfere with analysis of study results, such as history of non-compliance or unreliability, or do have any additional medical condition that contraindicates non-surgical treatment Local exclusion criteria Mucosal diseases such as erosive lichen planus in the area to be treated. History of local irradiation therapy. Implants with peri-implant bone loss beyond 2/3 of the implant length

Central Contact Person:

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

Ana Carillo de Albornoz Sainz

Phone

+34627588248

acarill02@ucm.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mariano Sanz Alonso

Organizational Affiliation

University Complutense Madrid

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Non-surgical Electrolytic Cleaning Peri-implantitis

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