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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-09

Study Completion Date

2021-08-18

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

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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.

Conditions

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Gingival Recession Platelet Derived Growth Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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collagen matrix + platelet-derived growth factor

Root coverage procedure using collagen matrix + platelet-derived growth factor for the treatment of multiple adjacent gingival recessions

Group Type EXPERIMENTAL

Root coverage procedures

Intervention Type PROCEDURE

Treatment of multiple adjacent gingival recession using a coronally advanced flap

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

Group Type ACTIVE_COMPARATOR

Root coverage procedures

Intervention Type PROCEDURE

Treatment of multiple adjacent gingival recession using a coronally advanced flap

Interventions

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Root coverage procedures

Treatment of multiple adjacent gingival recession using a coronally advanced flap

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes