Collagen Matrix + rhPDGF-BB vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences

Harvard Medical School (HMS and HSDM)

Status: Active, not recruiting

Conditions: Implant Complication

Treatments: Other: Prosthetic-surgical approach + autogenous graft; Other: Prosthetic-surgical approach + graft substitute

Study type: Interventional

Funder types: Other

Identifiers

NCT05576922

Delta IMPL REC (IRB22-0637)

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Connective tissue graft

Active Comparator group

Description:

Autogenous connective tissue graft harvested from the palate as a free gingival graft and then de-epithelialized

Treatment:

Other: Prosthetic-surgical approach + autogenous graft

Collagen matrix + rhPDGF-BB

Experimental group

Description:

Xenogeneic cross-linked collagen matrix + recombinant human platelet-derived growth factor-BB

Treatment:

Other: Prosthetic-surgical approach + graft substitute