Vertical Soft Tissue Augmentation With CTG vs ADM
- Conditions
- Implant Complication
- Interventions
- Procedure: Vertical soft tissue augmentation
- Registration Number
- NCT05729607
- Lead Sponsor
- Harvard Medical School (HMS and HSDM)
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 28
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dermal matrix + EMD Vertical soft tissue augmentation Acellular dermal matrix and enamel matrix derivative Connective tissue graft Vertical soft tissue augmentation Autogenous connective tissue graft harvested from the palate as a free gingival graft and then de-epithelialized
- Primary Outcome Measures
Name Time Method Change in Soft tissue dehiscence depth 12 months 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)
- Secondary Outcome Measures
Name Time Method Mucosal thickness changes 3, 6, and 12 months Changes within the mucosal thickness measured with ultrasonography (expressed in mm)
Professional esthetic assessment (IDES) 12 months 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)
3D Volumetric changes 3, 6, and 12 months Changes within the buccal contour measured by superimposing digital impressions obtained with optical scanning (expressed in mm\^3)
Complete peri-implant soft tissue dehiscence (PSTD) coverage 12 months Percentage of cases with complete resolution of the implant esthetic complication (expressed as a percentage)
mean peri-implant soft tissue dehiscence (PSTD) coverage 12 months 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)
Post-operative pain 14 days after the surgery Patient-reported pain after the surgical procedure (expressed with a 0-10 visual analogue scale \[VAS\])
Trial Locations
- Locations (1)
Harvard School of Dental Medicine
🇺🇸Boston, Massachusetts, United States