Implant Complication Clinical Trial
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
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
Status | Recruiting |
Enrollment | 28 |
Est. completion date | November 27, 2026 |
Est. primary completion date | February 27, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Harvard School of Dental Medicine | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Harvard Medical School (HMS and HSDM) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Mucosal thickness changes | Changes within the mucosal thickness measured with ultrasonography (expressed in mm) | 3, 6, and 12 months | |
Secondary | 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 | |
Secondary | Post-operative pain | Patient-reported pain after the surgical procedure (expressed with a 0-10 visual analogue scale [VAS]) | 14 days after the surgery | |
Secondary | 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 |
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