Surgical Treatment of Peri-implantitis Using a Bone Substitute With or Without a Resorbable Collagen Membrane

NCT05699343 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: STUDY22080031
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the present randomized clinical trial will be to compare two surgical methods of treating peri-implantitis. This study will determine if surgical debridement of peri-implantitis bone defects, including air powder abrasive (APA) decontamination of implant surfaces, in combination with the placement of a bone graft, differs in treatment outcomes compared to placing the same bone graft material with a resorbable collagen membrane placed over the bone graft.

Conditions

Peri-Implantitis; Surgery

Keywords

peri-implantitis; bone augmentation; collagen membrane; surgical treatment; dental implant

Outcome Measures

Primary Outcomes (5)

• Successful Treatment of Peri-Implantitis

  Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement. Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. These criteria will be assessed at 12 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.

  1 year

• Successful Treatment of Peri-Implantitis

  Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement. Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. These criteria will be assessed at 24 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.

  2 years

• Successful Treatment of Peri-Implantitis

  Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement. Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. These criteria will be assessed at 36 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.

  3 years

• Successful Treatment of Peri-Implantitis

  Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement. Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. These criteria will be assessed at 48 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.

  4 years

• Successful Treatment of Peri-Implantitis

  Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement. Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. These criteria will be assessed at 60 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.

  5 years

Secondary Outcomes (10)

• Radiographic Marginal Bone Loss (MBL)

  8 months

• Radiographic Marginal Bone Loss (MBL)

  12 months

• Peri-Implant Bleeding on Probing

  8 months

• Peri-Implant Bleeding on Probing

  12 months

• Peri-Implant Probing Depth

  8 months

Study Arms (2)

Bone grafting with collagen membrane

EXPERIMENTAL

This arm will receive surgical intervention involving placement of a bone xenograft subsitute (InterOss Collagen) into the peri-implant bone defect with a collagen membrane (InterCollagen Guide) placed over the bone graft.

Procedure: InterOss Collagen (Bone xenograft) and InterOss Collagen Guide (Collagen membrane)

Bone grafting without collagen membrane

ACTIVE COMPARATOR

This arm will receive surgical intervention involving placement of a bone xenograft subsitute (InterOss Collagen) into the peri-implant bone defect with no collagen membrane placed over the graft.

Procedure: InterOss Collagen (Bone xenograft)

Interventions

InterOss Collagen (Bone xenograft) and InterOss Collagen Guide (Collagen membrane) PROCEDURE

Group will receive InterOss Collagen and InterOss Collagen Guide during surgical intervention visit.

Bone grafting with collagen membrane

InterOss Collagen (Bone xenograft) PROCEDURE

Group will only receive InterOss Collagen during surgical intervention visit.

Bone grafting without collagen membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 years or older
• be patients of record at the University of Pittsburgh Periodontics Department
• Systemically healthy patients
• Full-mouth plaque score and full-mouth bleeding score ≤ 30% (measured at six sites per tooth)
• Study individuals will be included if they met the following criteria: (a) one or more peri-implant sites with PPD ≥6 mm combined with BOP/suppuration, and (b) peri-implant marginal bone loss, defined as a crater like defect ≥3 mm as assessed from intra- oral radiographs, (c) Infrabony circumferential defect of more than 270° determined by CBCT, (d) crown not possible to retrieve before surgery

You may not qualify if:

• Unlikely to be able to comply with study procedures and unable to return to SDM for multiple appointments over the course of about a year.
• Uncontrolled pathologic processes in the oral cavity (cancer and active periodontal disease)
• History of allergic reactions to dental local anesthetics
• History of head and neck chemotherapy or radiation within 5 years prior to surgery
• Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, such as HIV infection, Paget's disease, osteoporosis, etc.
• Reported diagnosis of diabetes mellitus
• Patients taking corticosteroids, IV bisphosphonates, or any immunosuppressant medication that could influence post-operative healing and/or osseointegration
• Smokes more than 10 cigarettes/day (self-reported)
• History or current medications with known side effects of gingival growth (including any of the following: phenytoin, phenobarbital, lamotrigine, vigabatrin, ethosuximide, topiramate, primidone, nifedipine, diltazem, amlodipine, felodipine, verapamil, cyclosporine).
• Present alcohol and/or drug abuser (self-reported)
• Pregnant, unsure pregnancy status, or lactating females (self-reported), or planning to become pregnant within 1 year of study enrollment

Sponsors & Collaborators

• Andrea Ravida: lead
• SigmaGraft Inc.: collaborator

Study Sites (1)

University of Pittsburgh School of Dental Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Andrea Ravida, DDS MS PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Periodontics Program Director

Model Details: The present study will be a parallel, randomized single center clinical trial where participants will be randomized in to 2 groups: treatment with or without resorbable collagen membrane.

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: January 26, 2023
• Study Start: January 30, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available at completion of study and be available for 7 years following final reporting.
• Access Criteria: Access to identifiable information will only be granted to authorized representatives from the University of Pittsburgh's Office of Research Protections who may review information to monitor the conduct of this study. De-identified data will be shared with the study sponsor, Sigma Graft Inc. This de-identified information may also be used by other researchers for future research studies.

Locations

US (1)