Vertical Soft Tissue Augmentation With CTG vs ADM

Harvard Medical School (HMS and HSDM)

Status: Enrolling

Conditions: Implant Complication

Treatments: Procedure: Vertical soft tissue augmentation

Study type: Interventional

Funder types: Other

Identifiers

NCT05729607

ITI IMP (22-0600)

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Connective tissue graft

Active Comparator group

Description:

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

Treatment:

Procedure: Vertical soft tissue augmentation

Procedure: Vertical soft tissue augmentation

Dermal matrix + EMD

Experimental group

Description:

Acellular dermal matrix and enamel matrix derivative

Treatment:

Procedure: Vertical soft tissue augmentation

Procedure: Vertical soft tissue augmentation