Recruiting

Connective Tissue Graft vs. Acellular Dermal Matrix

Sponsor:

Harvard Medical School (HMS and HSDM)

Code:

NCT05729607

Conditions

Implant Complication

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Vertical soft tissue augmentation

Vertical soft tissue augmentation

Study Details

Brief 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

Conditions

Implant Complication

Study ID

NCT05729607

Start date

May 26, 2023

Status verified date

Sep, 2025

Completion date

Nov 27, 2027

Anticipated

Primary completion date

Feb 27, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 are:

  • 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

Study Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Connective tissue graft

Autogenous connective tissue graft harvested from the palate as a free gingival graft and then de-epithelialized

experimental: Dermal matrix + EMD

Acellular dermal matrix and enamel matrix derivative

Interventions

Vertical soft tissue augmentation

Vertical soft tissue augmentation with autogenous connective tissue graft (CTG)

Vertical soft tissue augmentation

Vertical soft tissue augmentation with acellular dermal matrix (ADM) and enamel matrix derivative (EMD)

Primary outcome measure

  • Change in Soft tissue dehiscence depth [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Lorenzo Tavelli, DDS, MS

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

Locations

Harvard School of Dental Medicine

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Lorenzo Tavelli, DDS, MS

7346044364lorenzo_tavelli@hsdm.harvard.edu

More Information

Sponsor

Harvard Medical School (HMS and HSDM)

Last update posted

Sep 18, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Harvard Medical School (HMS and HSDM) on 2025-09-18.