Vertical Soft Tissue Augmentation With CTG vs ADM

NCT ID: NCT05729607

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-26

Study Completion Date

2027-11-27

Brief Summary

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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

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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.

Conditions

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Implant Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel-arm
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Connective tissue graft

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

Group Type ACTIVE_COMPARATOR

Vertical soft tissue augmentation

Intervention Type PROCEDURE

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

Dermal matrix + EMD

Acellular dermal matrix and enamel matrix derivative

Group Type EXPERIMENTAL

Vertical soft tissue augmentation

Intervention Type PROCEDURE

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

Interventions

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Vertical soft tissue augmentation

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

Intervention Type PROCEDURE

Vertical soft tissue augmentation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role lead

Responsible Party

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Lorenzo Tavelli

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lorenzo Tavelli, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Dental Medicine, Boston, USA

Locations

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Harvard School of Dental Medicine

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lorenzo Tavelli, DDS, MS

Role: CONTACT

734-604-4364

Facility Contacts

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Lorenzo Tavelli, DDS, MS

Role: primary

7346044364

Other Identifiers

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ITI IMP (22-0600)

Identifier Type: -

Identifier Source: org_study_id

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