The Effect of Recombinant Human Platelet-derived Growth Factor in Combination With Collagen Matrix for the Treatment of Multiple Adjacent Gingival Recessions: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Mean Root Coverage
Study Overview
Brief Summary
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
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
collagen matrix + platelet-derived growth factor
Root coverage procedure using collagen matrix + platelet-derived growth factor for the treatment of multiple adjacent gingival recessions
Intervention: Root coverage procedures (Procedure)
collagen matrix alone
Root coverage procedure using collagen matrix alone (without the use of the platelet-derived growth factor) for the treatment of multiple adjacent gingival recessions
Intervention: Root coverage procedures (Procedure)
Outcomes
Primary Outcomes
Mean Root Coverage
Time Frame: 6 months
amount of recession reduction compared to the baseline recession depth
Keratinized tissue width gain
Time Frame: 6 months
amount of keratinized tissue width gain from the baseline
Gingival thickness gain
Time Frame: 6 months
amount of gingival thickness gain from the baseline
Secondary Outcomes
- 3D volumetric changes(6 months)
- Esthetic outcomes(6 months)
- Patient-related outcomes(6 months)
- Tissue perfusion variations(6 months)
Investigators
Lorenzo Tavelli
Principal Investigator
University of Michigan