Vertical Soft Tissue Augmentation With CTG vs ADM

Study Overview
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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.

Official Title
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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

Conditions
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Implant Complication

Intervention / Treatment
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* Procedure: Vertical soft tissue augmentation
* Procedure: Vertical soft tissue augmentation


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel-arm
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Connective tissue graft<br>Autogenous connective tissue graft harvested from the palate as a free gingival graft and then de-epithelialized | Procedure: Vertical soft tissue augmentation<br>* Vertical soft tissue augmentation with autogenous connective tissue graft (CTG)<br>|
| Experimental: Dermal matrix + EMD<br>Acellular dermal matrix and enamel matrix derivative | Procedure: Vertical soft tissue augmentation<br>* Vertical soft tissue augmentation with acellular dermal matrix (ADM) and enamel matrix derivative (EMD)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Soft tissue dehiscence depth | Change of the depth of the Soft tissue dehiscence (vertical measurement of the complication, in relation to the level of the cemento-enamel junction of the contralateral homologous tooth) at 12 months compared to baseline (expressed in millimeters) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete peri-implant soft tissue dehiscence (PSTD) coverage | Percentage of cases with complete resolution of the implant esthetic complication (expressed as a percentage) | 12 months | 
| mean peri-implant soft tissue dehiscence (PSTD) coverage | Percentage of coverage of the soft tissue dehiscence compared to baseline, measured with a formula considering final PSTD depth and initial PSTD depth (expressed as a percentage) | 12 months | 
| Mucosal thickness changes | Changes within the mucosal thickness measured with ultrasonography (expressed in mm) | 3, 6, and 12 months | 
| 3D Volumetric changes | Changes within the buccal contour measured by superimposing digital impressions obtained with optical scanning (expressed in mm^3) | 3, 6, and 12 months | 
| Post-operative pain | Patient-reported pain after the surgical procedure (expressed with a 0-10 visual analogue scale [VAS]) | 14 days after the surgery | 
| Professional esthetic assessment (IDES) | Esthetic outcomes of the treatment assessed by a calibrated operator using the Implant soft tissue Dehiscence coverage Esthetic Score (IDES) (expressed using points, based on the IDES classification system from Zucchelli et al. 2021) The range is from 0 (worst outcome) to 10 (best outcome) | 12 months |