Vertical Soft Tissue Augmentation With CTG vs ADM

NCT05729607 | Recruiting

• 1 other identifier: ITI IMP (22-0600)
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Soft tissue dehiscence depth

  Change of the depth of the Soft tissue dehiscence (vertical measurement of the complication, in relation to the level of the cemento-enamel junction of the contralateral homologous tooth) at 12 months compared to baseline (expressed in millimeters)

  12 months

Secondary Outcomes (6)

• Complete peri-implant soft tissue dehiscence (PSTD) coverage

  12 months

• mean peri-implant soft tissue dehiscence (PSTD) coverage

  12 months

• Mucosal thickness changes

  3, 6, and 12 months

• 3D Volumetric changes

  3, 6, and 12 months

• Post-operative pain

  14 days after the surgery

Study Arms (2)

Connective tissue graft

ACTIVE COMPARATOR

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

Procedure: Vertical soft tissue augmentation

Dermal matrix + EMD

EXPERIMENTAL

Acellular dermal matrix and enamel matrix derivative

Procedure: Vertical soft tissue augmentation

Interventions

Vertical soft tissue augmentation PROCEDURE

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

Connective tissue graft

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard Medical School (HMS and HSDM): lead

Study Sites (1)

Harvard School of Dental Medicine

Boston, Massachusetts, 02115, United States

RECRUITING

Study Officials

• Lorenzo Tavelli, DDS, MS

  Harvard School of Dental Medicine, Boston, USA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Tavelli, DDS, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Parallel-arm

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: May 26, 2023
• Primary Completion (Estimated): February 27, 2027
• Study Completion (Estimated): November 27, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)