Vertical Soft Tissue Augmentation With CTG vs ADM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vertical soft tissue augmentation, Vertical soft tissue augmentation.
- Who it may be relevant to
- Registry conditions: Implant Complication. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Vertical Soft Tissue Augmentation With Dermal Matrix and Enamel Matrix Derivative vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences in the Esthetic Zone: A Randomized, Controlled, Clinical, Trial
Overview
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.
Interventions
- Procedure Vertical soft tissue augmentation
Vertical soft tissue augmentation with autogenous connective tissue graft (CTG) - Procedure Vertical soft tissue augmentation
Vertical soft tissue augmentation with acellular dermal matrix (ADM) and enamel matrix derivative (EMD)
Primary outcome measures
- Change in Soft tissue dehiscence depth [Time frame: 12 months]
Secondary outcome measures (6)
- Complete peri-implant soft tissue dehiscence (PSTD) coverage [Time frame: 12 months]
- mean peri-implant soft tissue dehiscence (PSTD) coverage [Time frame: 12 months]
- Mucosal thickness changes [Time frame: 3, 6, and 12 months]
- 3D Volumetric changes [Time frame: 3, 6, and 12 months]
- Post-operative pain [Time frame: 14 days after the surgery]
- Professional esthetic assessment (IDES) [Time frame: 12 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Harvard School of Dental Medicine — Boston
Identifiers
NCT: NCT05729607 · ITI IMP (22-0600)