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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Gingival Recession, Platelet Derived Growth Factor

Intervention / Treatment
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* Procedure: Root coverage procedures


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: collagen matrix + platelet-derived growth factor<br>Root coverage procedure using collagen matrix + platelet-derived growth factor for the treatment of multiple adjacent gingival recessions | Procedure: Root coverage procedures<br>* Treatment of multiple adjacent gingival recession using a coronally advanced flap<br>|
| Active Comparator: collagen matrix alone<br>Root coverage procedure using collagen matrix alone (without the use of the platelet-derived growth factor) for the treatment of multiple adjacent gingival recessions | Procedure: Root coverage procedures<br>* Treatment of multiple adjacent gingival recession using a coronally advanced flap<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Root Coverage | amount of recession reduction compared to the baseline recession depth | 6 months | 
| Keratinized tissue width gain | amount of keratinized tissue width gain from the baseline | 6 months | 
| Gingival thickness gain | amount of gingival thickness gain from the baseline | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3D volumetric changes | Soft tissue volumetric variation evaluated with digital softwares | 6 months | 
| Tissue perfusion variations | Tissue perfusion variations compared to baseline at the different follow-up using ultrasonography | 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 | 6 months | 
| Esthetic outcomes | evaluated using the root coverage esthetic score (from 0 to 10) | 6 months |