NCT05729607NARecruitingAccepts Healthy Volunteers
Vertical Soft Tissue Augmentation With CTG vs ADM
Harvard Medical School (HMS and HSDM)
Start Date
5/26/2023
Completion Date
11/27/2027
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 Criteria
Age Range: 18 years to 99 years
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
Interventions
PROCEDURE
Vertical soft tissue augmentation
PROCEDURE
Vertical soft tissue augmentation
Conditions
Implant Complication
Locations
Harvard School of Dental Medicine
Boston, Massachusetts 02115
United States