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

N/AActive Not RecruitingNCT05576922

Harvard Medical School (HMS and HSDM)28 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Implant Complication

Interventions

Prosthetic-surgical approach + autogenous graftOTHER

Coronally advanced flap with an autogenous graft (CTG)

Prosthetic-surgical approach + graft substituteOTHER

Coronally advanced flap with a graft substitute (collagen matrix and rhPDGF-BB)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Harvard School of Dental Medicine

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Soft tissue dehiscence reduction

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)

Time frame: 6 and 12 months

Secondary Outcomes

Complete peri-implant soft tissue dehiscence (PSTD) coverage

Percentage of cases with complete resolution of the implant esthetic complication (expressed as a percentage)

Time frame: 6 and 12 months

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)

Time frame: 6 and 12 months

Mucosal thickness changes

Changes within the mucosal thickness measured with ultrasonography (expressed in mm)

Time frame: 3, 6 and 12 months

3D Volumetric changes

Changes within the buccal contour measured by superimposing digital impressions obtained with optical scanning (expressed in mm\^3)

Time frame: 3, 6 and 12 months

Post-operative pain

Patient-reported pain after the surgical procedure (expressed with a 0-10 visual analogue scale \[VAS\])

Time frame: 14 days after the surgery

Professional esthetic assessment

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)

Data from ClinicalTrials.gov

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