Loading clinical trials...

ACTIVE_NOT_RECRUITINGNA

Collagen Matrix + rhPDGF-BB vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences

Xenogeneic Collagen Matrix Loaded With rhPDGF-BB vs Autogenous Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences: A Randomized, Controlled, Clinical, Trial

NCT05576922•Harvard Medical School (HMS and HSDM)

View on ClinicalTrials.gov

Summary

The study aims at comparing two different approaches for the treatment of implant esthetic complications (peri-implant soft tissue dehiscences): autogenous connective tissue graft vs collagen matrix + recombinant human platelet derived growth factor-BB

Detailed Description

The present randomized clinical trial aims at investigating two approaches (autogenous connective tissue graft vs collagen matrix + recombinant human platelet derived growth factor-BB) when performed in combination with the prosthetic-surgical approach for the treatment of peri-implant soft tissue dehiscences. Clinical, volumetric, ultrasonographic and patient-reported outcomes will be evaluated at different time points up to 1 year.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Age ≥ 18 years,
•Periodontally and systemically healthy,
•Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth), iv) Presence of single dental implant in the anterior area (from the first right premolar to the first left premolar) showing a PSTD, with the subjects searching for treatment of this condition,
•Peri-implant papillae not flat (PSTD subclass a or b) (Zucchelli et al., 2019), vi) Implants diagnosed as healthy (Berglundh et al., 2018),
•Ability to perform good oral hygiene

Exclusion Criteria

•Contraindications for surgery,
•Systemic condition (e.g. diabetes mellitus, HIV, cancer, etc) that could compromise wound healing,
•Patients pregnant or attempting to get pregnant (self-reported),
•Untreated periodontitis,
•Untreated peri-implant mucositis or peri-implantitis (Berglundh et al., 2018),
•Smoking, defined as self-reported daily habit. Occasional smokers won't be excluded,
•History of soft tissue grafting at the implant site showing PSTD within the last 6 months.
•Indications for surgical intervention will be established based on patient's esthetic demands and peri-implant soft tissue phenotype.

Locations (1)

Harvard School of Dental Medicine

Boston, Massachusetts, United States

Key Dates

Start Date

January 4, 2023

Primary Completion Date

October 20, 2025

Completion Date

October 21, 2025

Last Updated

April 10, 2025

Enrollment

ACTUAL participants

Conditions

Implant Complication

Interventions

Prosthetic-surgical approach + autogenous graft

OTHER

Prosthetic-surgical approach + graft substitute

OTHER

Vertical Soft Tissue Augmentation With CTG vs ADM

NCT05729607

Implant Complication

View study

RECRUITINGNA

Improvement of Symptoms After Removal of the Essure® Contraceptive Implant

NCT06355713

Implant ComplicationContraceptive Device; Complications

View study

ACTIVE_NOT_RECRUITINGNA

Dental Implant Stability Placed in Healed Bony Sites Using Oversized Drilling Versus Conventional Drilling Protocol

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Collagen Matrix + rhPDGF-BB vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences

Inclusion Criteria

Exclusion Criteria

Vertical Soft Tissue Augmentation With CTG vs ADM

Improvement of Symptoms After Removal of the Essure® Contraceptive Implant

Dental Implant Stability Placed in Healed Bony Sites Using Oversized Drilling Versus Conventional Drilling Protocol

Rehabilitation of Single Aesthetic Areas Using Narrow Diameter Implants

Comparison Between Primary and Secondary Implant Stability of Hybrid Versus Resorbable Blast Media (RBM) Surfaces Using Resonance Frequency Analysis

Prosthetic and Biological Complications of Implant Supported Prostheses