Vertical Soft Tissue Augmentation With CTG vs ADM

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Harvard Medical School (HMS and HSDM)
Study ID
NCT05729607
Status
Recruiting

Conditions

  • Implant Complication

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Vertical soft tissue augmentation — PROCEDURE
    Vertical soft tissue augmentation with autogenous connective tissue graft (CTG)
  • Vertical soft tissue augmentation — PROCEDURE
    Vertical soft tissue augmentation with acellular dermal matrix (ADM) and enamel matrix derivative (EMD)

Study Details

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

Key Dates

Start date
May 26, 2023
Status verified
Sep 2025
Primary completion
Feb 27, 2027
Completion
Nov 27, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Harvard School of Dental MedicineBostonMassachusetts02115
Lorenzo Tavelli, DDS, MS
7346044364

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