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Completed

NCT Number: NCT04462237

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Root coverage procedures

Procedure

Treatment of multiple adjacent gingival recession using a coronally advanced flap

Primary outcomes

  1. Mean Root Coverage

    Time frame: 6 months

    amount of recession reduction compared to the baseline recession depth

  2. Keratinized tissue width gain

    Time frame: 6 months

    amount of keratinized tissue width gain from the baseline

  3. Gingival thickness gain

    Time frame: 6 months

    amount of gingival thickness gain from the baseline

Secondary outcomes

  1. 3D volumetric changes

    Time frame: 6 months

    Soft tissue volumetric variation evaluated with digital softwares

  2. Tissue perfusion variations

    Time frame: 6 months

    Tissue perfusion variations compared to baseline at the different follow-up using ultrasonography

  3. Patient-related outcomes

    Time frame: 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

  4. Esthetic outcomes

    Time frame: 6 months

    evaluated using the root coverage esthetic score (from 0 to 10)

Other outcomes

  1. Differences in Angiogenic Biomarkers

    Time frame: 3 months

    Within-subject difference between the concentrations at the control and test sites

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 8, 2020
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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