Skip to main content
OpenTrials
Completed

NCT Number: NCT05819515

Treatment of Gingival Recession Defects Using Platelet-Rich Fibrin With an Allogenic Dermal Matrix

The study aims to test the non-inferiority of an Allogenic Dermal Matrix with Platelet-Rich Fibrin for treatment of gingival recessions in comparison to the Connective Tissue Graft.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan - Ann Arbor

Ann Arbor, Michigan, 48109, United States

About this study

Currently the Connective Tissue Graft (CTG) is referred to as the gold standard in terms of the grafting material for the treatment of gingival recession defects. This study test the non-inferiority of the Allogenic Dermal Matrix (ADM) with Platelet-Rich Fibrin (PRF) to that of the CTG, in terms of the amount of root coverage obtained after the procedure.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Periodontally and systemically healthy adults
  • Full-mouth plaque score and full-mouth bleeding score ≤ 20%
  • Presence of at least one 3 mm or deeper gingival recession, with at least 1.5 mm of Keratinized tissue, and 1 mm of gingival thickness) 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 undergoing periodontal surgery
  • Teeth with more than Grade II mobility, or furcation involvement of Class III
  • Patients pregnant or attempting to get pregnant (self-reported), or nursing women
  • Untreated/active periodontitis, or other untreated acute infections at the surgical site
  • Untreated malignancies at the surgical site
  • Persistence of uncorrected gingival trauma from traumatic toothbrushing
  • 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, or active tobacco chewing, or chronic vaping
  • Patients with any known history of blood disorders or complications such as abnormal concentration of thrombin and factor XIII in plasma, or hemophilia
  • Patients with significant co-morbidities, such as obesity, uncontrolled diabetes, immunosuppression, severe endocrine-induced bone diseases, signs of malnourishment, those receiving immunosuppressive therapy, poor tissue oxygenation or perfusion, and pre- or post-operative radiation
  • Patients with known sensitivity to Polysorbate 20, Cefoxitin, Lincomycin, polymyxin B, Vancomycin

Treatment and study plan

Tunneled coronally advanced flap

Procedure

Describes the flap design for both treatment arms

Primary outcomes

  1. Mean root coverage (mRC)

    Time frame: Assessed at 6 months

    Measured as a percentage of the total baseline recession defect that coverage was obtained at.

  2. Complete root coverage (CRC)

    Time frame: Assessed at 6 months

    Measured as a percentage of total treated sites, that obtained a full coverage of the recession defect

  3. Keratinized tissue (KT) gain

    Time frame: Assessed at 6 months

    Measured in mm

  4. Gingival thickness (GT) gain

    Time frame: Assessed at 6 months

    Measured in mm

  5. Patient-reported outcomes (PROMs)

    Time frame: Measured from the day of the procedure up to a maximum of 1 month

    In terms of pain/discomfort at the palatal donor site or patient's arm. Measured using a scale from 0 (lowest) to 10 (highest).

  6. Duration of surgical procedure

    Time frame: During surgery

    Including the length of surgical procedure, drawing of blood, and preparation of PRF, harvesting of the autogenous CTG. Measured in minutes.

Secondary outcomes

  1. Professionally evaluated esthetic score

    Time frame: Assessed at 6 months

    Assessed using the Root coverage Esthetic Score (RES) system (from 0 lowest, to 10 highest)

  2. Soft tissue volume changes over time

    Time frame: Changes of from baseline (prior to treatment) compared with 3 and 6 months

    Assessed using 3D scanner imaging in the units of mm

  3. Soft tissue volume changes over time

    Time frame: Measured throughout the study to assess changes from immediate post-op (right after the completion of surgical appointment) until the final recall at 6 months

    Assessed using dental ultrasonography in the units of mm

  4. Soft tissue blood flow changes over time

    Time frame: Measured throughout the study to assess changes from immediate post-op (right after the completion of surgical appointment) until the final recall at 6 months

    Assessed and quantified using dental ultrasonography

  5. Patient-reported esthetics

    Time frame: Measured at baseline and at 6 months, and compared between these time points to provide subjective esthetic results

    Based on a visual analogue scale (VAS), measured as numbers from 0 (lowest) to 10 (highest).

  6. Patient-reported satisfaction

    Time frame: Measured at 6 months to provide the satisfaction score in VAS scale

    Based on a visual analogue scale (VAS), measured as numbers from 0 (lowest) to 10 (highest).

  7. Patient-reported post-operative pain as measured with a mobile application

    Time frame: From the day of the procedure until 1 month after the surgical time point

    Measured using a mobile application at the recession grafted site, the donor site on the palate, and the donor site for the venopuncture.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Treatment of Gingival Recession Defects Using Platelet-Rich Fibrin With an Allogenic Dermal Matrix, Compared to the Connective Tissue Graft: A Parallel-arm, Randomized, Controlled, Assessor-blind, Non-inferiority Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2023
Registry last updated
Jul 12, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.