Clinical trial NCT05576922: Collagen Matrix + rhPDGF-BB vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Implant Complication
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel-arm
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Soft tissue dehiscence reduction
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Complete peri-implant soft tissue dehiscence (PSTD) coverage
timeFrame: 6 and 12 months
measure: mean peri-implant soft tissue dehiscence (PSTD) coverage
timeFrame: 6 and 12 months
measure: Mucosal thickness changes
timeFrame: 3, 6 and 12 months
measure: 3D Volumetric changes
timeFrame: 3, 6 and 12 months
measure: Post-operative pain
timeFrame: 14 days after the surgery
measure: Professional esthetic assessment
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Harvard School of Dental Medicine, Boston, USA
name: Lorenzo Tavelli, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: