Collagen Matrix + rhPDGF-BB vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences
NCT ID: NCT05576922
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
28 participants
INTERVENTIONAL
2023-01-04
2025-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Connective tissue graft
Autogenous connective tissue graft harvested from the palate as a free gingival graft and then de-epithelialized
Prosthetic-surgical approach + autogenous graft
Coronally advanced flap with an autogenous graft (CTG)
Collagen matrix + rhPDGF-BB
Xenogeneic cross-linked collagen matrix + recombinant human platelet-derived growth factor-BB
Prosthetic-surgical approach + graft substitute
Coronally advanced flap with a graft substitute (collagen matrix and rhPDGF-BB)
Interventions
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Prosthetic-surgical approach + autogenous graft
Coronally advanced flap with an autogenous graft (CTG)
Prosthetic-surgical approach + graft substitute
Coronally advanced flap with a graft substitute (collagen matrix and rhPDGF-BB)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Harvard Medical School (HMS and HSDM)
OTHER
Responsible Party
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Lorenzo Tavelli
Principal Investigator
Principal Investigators
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Lorenzo Tavelli, DDS, MS
Role: PRINCIPAL_INVESTIGATOR
Harvard School of Dental Medicine, Boston, USA
Locations
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Harvard School of Dental Medicine
Boston, Massachusetts, United States
Countries
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Other Identifiers
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Delta IMPL REC (IRB22-0637)
Identifier Type: -
Identifier Source: org_study_id
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