Clinical trial NCT04462237: Recombinant Human Platelet-derived Growth Factor in Combination With Collagen Matrix
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Platelet Derived Growth Factor
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)
* 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

Primary outcomes:
measure: Mean Root Coverage
timeFrame: 6 months
measure: Keratinized tissue width gain
timeFrame: 6 months
measure: Gingival thickness gain
timeFrame: 6 months
Secondary outcomes:
measure: 3D volumetric changes
timeFrame: 6 months
measure: Tissue perfusion variations
timeFrame: 6 months
measure: Patient-related outcomes
timeFrame: 6 months
measure: Esthetic outcomes
timeFrame: 6 months
Other outcomes:
measure: Differences in Angiogenic Biomarkers
timeFrame: 3 months
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: University of Michigan
name: Lorenzo Tavelli, DDS, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: William Giannobile, DDS, MS, DMSc
role: STUDY_CHAIR
affiliation: University of Michigan
name: Hom-Lay Wang, DDS, MS, PhD
role: STUDY_DIRECTOR
References:
citation: Tavelli L, Barootchi S, Rodriguez MV, Mancini L, Majzoub J, Travan S, Sugai J, Chan HL, Kripfgans O, Wang HL, Giannobile WV. Recombinant human platelet-derived growth factor improves root coverage of a collagen matrix for multiple adjacent gingival recessions: A triple-blinded, randomized, placebo-controlled trial. J Clin Periodontol. 2022 Nov;49(11):1169-1184. doi: 10.1111/jcpe.13706. Epub 2022 Jul 31.