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Vertical Soft Tissue Augmentation With CTG vs ADM | Clinical Trials | Clareo Health

RECRUITINGNA

Vertical Soft Tissue Augmentation With CTG vs ADM

Vertical Soft Tissue Augmentation With Dermal Matrix and Enamel Matrix Derivative vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences in the Esthetic Zone: A Randomized, Controlled, Clinical, Trial

NCT05729607•Harvard Medical School (HMS and HSDM)

View on ClinicalTrials.gov

Summary

The study aims at comparing two different approaches for vertical soft tissue augmentation at implant sites exhibiting soft tissue dehiscences: autogenous connective tissue graft vs acellular dermal matrix + enamel matrix derivative

Detailed Description

The present randomized clinical trial aims at investigating two approaches (autogenous connective tissue graft vs acellular dermal matrix + enamel matrix derivative) when performed for vertical soft tissue augmentation at sites with 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 - 99 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)
•Presence of single functional dental implant in the anterior with a PSTD
•Implants diagnosed as healthy (Berglundh et al., 2018)

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 within the last 6 months

Locations (1)

Harvard School of Dental Medicine

Boston, Massachusetts, United States

Key Dates

Start Date

May 26, 2023

Primary Completion Date

February 27, 2027

Completion Date

November 27, 2027

Last Updated

September 18, 2025

Enrollment

ESTIMATED participants

Conditions

Implant Complication

Interventions

Vertical soft tissue augmentation

PROCEDURE

Vertical soft tissue augmentation

PROCEDURE

Contacts

Lorenzo Tavelli, DDS, MS

CONTACT

734-604-4364 lorenzo_tavelli@hsdm.harvard.edu

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Implant ComplicationContraceptive Device; Complications

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ACTIVE_NOT_RECRUITINGNA

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

NCT05576922

Implant Complication

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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: September 18, 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.

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Vertical Soft Tissue Augmentation With CTG vs ADM

Inclusion Criteria

Exclusion Criteria

Improvement of Symptoms After Removal of the Essure® Contraceptive Implant

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

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