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Treatment of Peri-implantitis With or Without Simultaneous Soft Tissue Augmentation

Primary Purpose

Peri-Implantitis

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Peri-implantitis reconstructive surgery

About this trial

This is an interventional treatment trial for Peri-Implantitis

Eligibility Criteria

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

Inclusion Criteria:

· Be able and willing to provide consent and sign the informed consent form.
- Be able and willing to comply with study procedures and follow-up appointments required by the study protocol.
- Age>18 years
- Presence of at least one implant affected with peri-implantitis, defined as the following con-dition: at least one site presenting peri-implant probing depth (PPD) >6 mm and simultane-ous presence of profuse BoP/SUP and a radiographically documented change in bone level greater than initial bone remodeling. In the likely event that a baseline radiographic image is absent, the bone level will be compared to where it would likely have been at the time of implant insertion and a difference of >3 mm from that level will be considered.
- Implants in function (i.e. loaded) for at least 1 year.
- Screw- and cement-retained suprastructures for both fixed and removable prostheses.

Exclusion Criteria:

Compromised systemic health which contraindicates the study procedures.
Pregnant or nursing women.
Cigarette smoking>5 per day
Systemic conditions compromising healing (i.e. diabetes mellitus). Patients with diabe-tes mellitus types I or II will be asked to provide information regarding their most re-cent HbA1c values. Only patients with HbA1c<7% will be enrolled.
Patients taking medications known to interfere with gingival or bone metabolism.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Xenograft+collagen membrane

Xenograft+collagen membrane+autologous soft tissue graft

Arm Description

Reconstructive approach (Xenograft+collegen membrane)

Reconstructive approach (Xenograft+collegen membrane) plus soft tissue graft (autologous, harvested as FGG)

Outcomes

Primary Outcome Measures

Clinical attachment level

linear distance (mm) from the implant platform to the bottom of the pocket

Secondary Outcome Measures

Probing depth

linear distance (mm) from the gingival margin to the bottom of the pocket

Disease resolution

No PD greater than or equal to 5 mm and simultaneous absence of BOP/SUP and no more than 0.5 mm change between 2 weeks and 12 and 24 months on radiograph

Mucosal recession

linear distance (mm) from the implant platform to the gingival margin

plaque index (minimum value 0, maximum 1)

binary outcome: yes/ no detected running the probe into the peri-implant sulcus

profuse bleeding

abundant bleeding evoked upon probing immediately after

BOP

bleeding upon probing: bleeding evoked upon probing after 1 second

suppuration

Binary: yes or no, detected upon probing or digital palpation

Gingival thickness

Measured in a horizontal direction at 1 mm from the gingival margin

Patient-reported outcome measures

pain-bleeding-aesthetic self-evaluation-swelling-discomfort

Radiographic bone levels

radiographic bone level changes between the 2 week and 12 and 24 month follow-ups

Full Information

NCT ID

NCT04323540

First Posted

March 23, 2020

Last Updated

March 25, 2020

Sponsor

George Eastman Dental Hospital, Italy

Collaborators

University of Belgrade

1. Study Identification

Unique Protocol Identification Number

NCT04323540

Brief Title

Treatment of Peri-implantitis With or Without Simultaneous Soft Tissue Augmentation

Official Title

Surgical Reconstructive Treatment of Peri-Implantitis With or Without Simultaneous Soft Tissue Augmentation: a Multi-center Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2020 (Anticipated)

Primary Completion Date

September 1, 2021 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

George Eastman Dental Hospital, Italy

Collaborators

University of Belgrade

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The study will aim to compare two modalities in the reconstructive treatment of peri-implantitis defects. More specifically, the control group will be a reconstructive approach (xenograft bone graft granules and collagen membrane, BioOss and BioGide, Geistlich, Wolhusen). The test group will be the same with the exception of an autologous sub-epithelial connective tissue palatal graft, sutured beneath the flap, which will be used in addition to grafting materials. Outcomes will include CAL, PD, MR, defect resolution, PI, BoP, SUPP, patient-reported outcome measures including an aesthetic self-evaluation.

Detailed Description

The study will aim to compare two modalities in the reconstructive treatment of peri-implantitis defects. More specifically, the control group will be a "pure" reconstructive approach (xenograft bone graft granules and reservable collagen membrane, BioOss and BioGide, Geistlich, Wolhusen). This is in accordance with gold standard practices of reconstructive therapy of peri-implant defects. The test group will be treated with the same approach and materials, with the exception of an autologous sub-epithelial connective tissue palatal graft, sutured beneath the flap, which will be used in addition to the grafting materials. The graft will be harvested from the homolateral palate (molar region). Outcomes will include CAL, clinical attachment level (primary outcome), PD or probing depth, MR or mucosal recession, defect resolution (composite outcome made up of simultaneous absence of PD>5 mm, BOP/SUP and bone level changes >0.5 mm, PI, BoP or bleeding upon probing, suppuration SUP on probing, SUP on palpation, patient-reported outcome measures including an aesthetic self-evaluation. The measures will be recorded at baseline, 6-, 12-, 18- and 24 months. Radiographic bone levels will be compared with 2 week image at 12 and 24 months

6. Conditions and Keywords

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

Peri-Implantitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Xenograft+collagen membrane

Arm Type

Active Comparator

Arm Description

Reconstructive approach (Xenograft+collegen membrane)

Arm Title

Xenograft+collagen membrane+autologous soft tissue graft

Arm Type

Experimental

Arm Description

Reconstructive approach (Xenograft+collegen membrane) plus soft tissue graft (autologous, harvested as FGG)

Intervention Type

Procedure

Intervention Name(s)

Peri-implantitis reconstructive surgery

Intervention Description

For both arms (excluding the already included information): defect debridement, removal of debris using titanium curettes, titanium brushes on the implant surface, irrigation with saline, application of sterile cotton pellets with saline solution. Grafting with (experimental) xenograft and soft tissue, or xenograft alone (control). Suture. Specific to control group (active comparator): the peri-implant defect will be filled with xenograft, and a collagen membrane will be fitted and trimmed to the defect area. Specific to test/experimental group: same as above (for control). In addition a soft tissue graft will be harvested from the palate and sutured to the buccal flap. The entire flap will then be sutured to the lingual flap.

Primary Outcome Measure Information:

Title

Clinical attachment level

Description

linear distance (mm) from the implant platform to the bottom of the pocket

Time Frame

change from baseline to: 6, 12, 18, 24 months

Secondary Outcome Measure Information:

Title

Probing depth

Description

linear distance (mm) from the gingival margin to the bottom of the pocket

Time Frame

6, 12, 18, 24 months

Title

Disease resolution

Description

No PD greater than or equal to 5 mm and simultaneous absence of BOP/SUP and no more than 0.5 mm change between 2 weeks and 12 and 24 months on radiograph

Time Frame

6, 12, 18, 24 months

Title

Mucosal recession

Description

linear distance (mm) from the implant platform to the gingival margin

Time Frame

6, 12, 18, 24 months

Title

plaque index (minimum value 0, maximum 1)

Description

binary outcome: yes/ no detected running the probe into the peri-implant sulcus

Time Frame

6, 12, 18, 24 months

Title

profuse bleeding

Description

abundant bleeding evoked upon probing immediately after

Time Frame

6, 12, 18, 24 months

Title

BOP

Description

bleeding upon probing: bleeding evoked upon probing after 1 second

Time Frame

6, 12, 18, 24 months

Title

suppuration

Description

Binary: yes or no, detected upon probing or digital palpation

Time Frame

6, 12, 18, 24 months

Title

Gingival thickness

Description

Measured in a horizontal direction at 1 mm from the gingival margin

Time Frame

6, 12, 18, 24 months

Title

Patient-reported outcome measures

Description

pain-bleeding-aesthetic self-evaluation-swelling-discomfort

Time Frame

6, 12, 18, 24 months

Title

Radiographic bone levels

Description

radiographic bone level changes between the 2 week and 12 and 24 month follow-ups

Time Frame

2 weeks, 12 months, 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: · Be able and willing to provide consent and sign the informed consent form. Be able and willing to comply with study procedures and follow-up appointments required by the study protocol. Age>18 years Presence of at least one implant affected with peri-implantitis, defined as the following con-dition: at least one site presenting peri-implant probing depth (PPD) >6 mm and simultane-ous presence of profuse BoP/SUP and a radiographically documented change in bone level greater than initial bone remodeling. In the likely event that a baseline radiographic image is absent, the bone level will be compared to where it would likely have been at the time of implant insertion and a difference of >3 mm from that level will be considered. Implants in function (i.e. loaded) for at least 1 year. Screw- and cement-retained suprastructures for both fixed and removable prostheses. Exclusion Criteria: Compromised systemic health which contraindicates the study procedures. Pregnant or nursing women. Cigarette smoking>5 per day Systemic conditions compromising healing (i.e. diabetes mellitus). Patients with diabe-tes mellitus types I or II will be asked to provide information regarding their most re-cent HbA1c values. Only patients with HbA1c<7% will be enrolled. Patients taking medications known to interfere with gingival or bone metabolism.

Central Contact Person:

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

Lucrezia Paternò Holtzman, DMD

Phone

+39.06.3241406

lucreziaph@gmail.com

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

Iva Milinkovic, DMD, PhD

iva.milinkovic@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luca Cordaro, MD, PhD

Organizational Affiliation

G. Eastman Dental Hospital Rome, Italy

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Treatment of Peri-implantitis With or Without Simultaneous Soft Tissue Augmentation

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