Recombinant Human Platelet-derived Growth Factor in Combination With Collagen Matrix

University of Michigan30 enrolled

Overview

The present randomized clinical trial is aimed at evaluating the efficacy of recombinant human platelet-derived growth factor in combination with collagen matrix for the treatment of multiple adjacent gingival recessions

Despite the fact that gingival recession is most often a generalized condition rather than being localized to a single tooth, most of the data currently found in the literature pertains to the treatment of localized gingival recessions. The gold standard treatment for this condition involves the use of an autogenous connective tissue graft, that is associated with increased patient morbidity. Biomaterials have progressively gained popularity due to their advantages when compared to autogenous grafts, such as unrestricted availability, avoidance of a secondary surgical site, reduction of the surgical time, and the patient's preference. Collagen matrix is one of the most used soft tissue substitute for the treatment of gingival recessions. Combining this scaffold material with a growth factor could enhance its outcomes. In particular, root coverage using platelet-derived growth factor can also promote regeneration of new cementum, periodontal ligament and bone. Therefore, the aim of the present study is to investigate the effect of platelet-derived growth factor in combination with collagen matrix outcomes for the treatment of multiple adjacent gingival recessions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Gingival Recession Platelet Derived Growth Factor

Interventions

Root coverage proceduresPROCEDURE

Treatment of multiple adjacent gingival recession using a coronally advanced flap

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) * At least two multiple adjacent gingival recessions (with at least one 2 mm or deeper) requiring surgical intervention for root coverage * No interproximal attachment/bone loss * No prior experience of root coverage procedures within the last 1 year * The patient must be able to perform good oral hygiene Exclusion Criteria: * Contraindications for periodontal surgery * Patients pregnant or attempting to get pregnant (self-reported) * Untreated periodontitis * Persistence of uncorrected gingival trauma from traumatic toothbrushing * Interdental attachment loss greater than 1 mm or furcation involvement in the teeth to be treated * Presence of severe tooth malposition, rotation or clinically significant super-eruption * Self-reported current smoking more than 10 cigarettes/day or pipe or cigar smoking * Allergy to collagen-based medical products

Locations (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Mean Root Coverage

amount of recession reduction compared to the baseline recession depth

Time frame: 6 months

Keratinized tissue width gain

amount of keratinized tissue width gain from the baseline

Time frame: 6 months

Gingival thickness gain

amount of gingival thickness gain from the baseline

Time frame: 6 months

Secondary Outcomes

3D volumetric changes

Soft tissue volumetric variation evaluated with digital softwares

Time frame: 6 months

Tissue perfusion variations

Tissue perfusion variations compared to baseline at the different follow-up using ultrasonography

Time frame: 6 months

Patient-related outcomes

Patient self reported perception of the procedure in terms of morbidity, satisfaction and esthetic outcomes. Visual analogue scales (from 0 to 100) will be used to assess these outcomes

Time frame: 6 months

Esthetic outcomes

evaluated using the root coverage esthetic score (from 0 to 10)

Time frame: 6 months

Data from ClinicalTrials.gov

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