Xenogeneic Collagen Matrix Loaded With rhPDGF-BB vs Autogenous Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences: A Randomized, Controlled, Clinical, Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Soft tissue dehiscence reduction
Study Overview
Brief Summary
The study aims at comparing two different approaches for the treatment of implant esthetic complications (peri-implant soft tissue dehiscences): autogenous connective tissue graft vs collagen matrix + recombinant human platelet derived growth factor-BB
Detailed Description
The present randomized clinical trial aims at investigating two approaches (autogenous connective tissue graft vs collagen matrix + recombinant human platelet derived growth factor-BB) when performed in combination with the prosthetic-surgical approach for the treatment of peri-implant soft tissue dehiscences. Clinical, volumetric, ultrasonographic and patient-reported outcomes will be evaluated at different time points up to 1 year.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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), iv) Presence of single dental implant in the anterior area (from the first right premolar to the first left premolar) showing a PSTD, with the subjects searching for treatment of this condition,
- •Peri-implant papillae not flat (PSTD subclass a or b) (Zucchelli et al., 2019), vi) Implants diagnosed as healthy (Berglundh et al., 2018),
- •Ability to perform good oral hygiene
Exclusion Criteria
- •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 showing PSTD within the last 6 months.
- •Indications for surgical intervention will be established based on patient's esthetic demands and peri-implant soft tissue phenotype.
Outcomes
Primary Outcomes
Soft tissue dehiscence reduction
Time Frame: 6 and 12 months
Reduction 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) compared to baseline (expressed in millimeters)
Secondary Outcomes
- Mucosal thickness changes(3, 6 and 12 months)
- Post-operative pain(14 days after the surgery)
- Professional esthetic assessment(12 months)
- mean peri-implant soft tissue dehiscence (PSTD) coverage(6 and 12 months)
- Complete peri-implant soft tissue dehiscence (PSTD) coverage(6 and 12 months)
- 3D Volumetric changes(3, 6 and 12 months)
Investigators
Lorenzo Tavelli
Principal Investigator
Harvard Medical School (HMS and HSDM)