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

Not Applicable

Completed

• Conditions: Gingival Recession; Platelet Derived Growth Factor
• Interventions: Procedure: Root coverage procedures

• Registration Number: NCT04462237
• Lead Sponsor: University of Michigan

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-08
• Study Start: 2020-09-09
• Primary Completion: 2021-08-18
• Study Completion: 2021-08-18
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-26
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
collagen matrix alone	Root coverage procedures	Root coverage procedure using collagen matrix alone (without the use of the platelet-derived growth factor) for the treatment of multiple adjacent gingival recessions
collagen matrix + platelet-derived growth factor	Root coverage procedures	Root coverage procedure using collagen matrix + platelet-derived growth factor for the treatment of multiple adjacent gingival recessions

Primary Outcome Measures

Name	Time	Method
Mean Root Coverage	6 months	amount of recession reduction compared to the baseline recession depth
Keratinized tissue width gain	6 months	amount of keratinized tissue width gain from the baseline
Gingival thickness gain	6 months	amount of gingival thickness gain from the baseline

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States