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

Primary Purpose

Gingival Recession

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tunneled coronally advanced flap
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Michigan - Ann Arbor

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Connective Tissue Graft

Allogenic Dermal Matrix with Platelet-Rich Fibrin

Arm Description

A connective tissue graft from the patient's palate will be used

An allogenic dermal matrix with the patient's platelet-rich fibrin will be used

Outcomes

Primary Outcome Measures

Mean root coverage (mRC)
Measured as a percentage of the total baseline recession defect that coverage was obtained at.
Complete root coverage (CRC)
Measured as a percentage of total treated sites, that obtained a full coverage of the recession defect
Keratinized tissue (KT) gain
Measured in mm
Gingival thickness (GT) gain
Measured in mm
Patient-reported outcomes (PROMs)
In terms of pain/discomfort at the palatal donor site or patient's arm. Measured using a scale from 0 (lowest) to 10 (highest).
Duration of surgical procedure
Including the length of surgical procedure, drawing of blood, and preparation of PRF, harvesting of the autogenous CTG. Measured in minutes.

Secondary Outcome Measures

Professionally evaluated esthetic score
Assessed using the Root coverage Esthetic Score (RES) system (from 0 lowest, to 10 highest)
Soft tissue volume changes over time
Assessed using 3D scanner imaging in the units of mm
Soft tissue volume changes over time
Assessed using dental ultrasonography in the units of mm
Soft tissue blood flow changes over time
Assessed and quantified using dental ultrasonography
Patient-reported esthetics
Based on a visual analogue scale (VAS), measured as numbers from 0 (lowest) to 10 (highest).
Patient-reported satisfaction
Based on a visual analogue scale (VAS), measured as numbers from 0 (lowest) to 10 (highest).
Patient-reported post-operative pain as measured with a mobile application
Measured using a mobile application at the recession grafted site, the donor site on the palate, and the donor site for the venopuncture.

Full Information

First Posted
March 21, 2023
Last Updated
August 9, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05819515
Brief Title
Treatment of Gingival Recession Defects Using Platelet-Rich Fibrin With an Allogenic Dermal Matrix
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 29, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Connective Tissue Graft
Arm Type
Active Comparator
Arm Description
A connective tissue graft from the patient's palate will be used
Arm Title
Allogenic Dermal Matrix with Platelet-Rich Fibrin
Arm Type
Experimental
Arm Description
An allogenic dermal matrix with the patient's platelet-rich fibrin will be used
Intervention Type
Procedure
Intervention Name(s)
Tunneled coronally advanced flap
Intervention Description
Describes the flap design for both treatment arms
Primary Outcome Measure Information:
Title
Mean root coverage (mRC)
Description
Measured as a percentage of the total baseline recession defect that coverage was obtained at.
Time Frame
Assessed at 6 months
Title
Complete root coverage (CRC)
Description
Measured as a percentage of total treated sites, that obtained a full coverage of the recession defect
Time Frame
Assessed at 6 months
Title
Keratinized tissue (KT) gain
Description
Measured in mm
Time Frame
Assessed at 6 months
Title
Gingival thickness (GT) gain
Description
Measured in mm
Time Frame
Assessed at 6 months
Title
Patient-reported outcomes (PROMs)
Description
In terms of pain/discomfort at the palatal donor site or patient's arm. Measured using a scale from 0 (lowest) to 10 (highest).
Time Frame
Measured from the day of the procedure up to a maximum of 1 month
Title
Duration of surgical procedure
Description
Including the length of surgical procedure, drawing of blood, and preparation of PRF, harvesting of the autogenous CTG. Measured in minutes.
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Professionally evaluated esthetic score
Description
Assessed using the Root coverage Esthetic Score (RES) system (from 0 lowest, to 10 highest)
Time Frame
Assessed at 6 months
Title
Soft tissue volume changes over time
Description
Assessed using 3D scanner imaging in the units of mm
Time Frame
Changes of from baseline (prior to treatment) compared with 3 and 6 months
Title
Soft tissue volume changes over time
Description
Assessed using dental ultrasonography in the units of mm
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
Title
Soft tissue blood flow changes over time
Description
Assessed and quantified using dental ultrasonography
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
Title
Patient-reported esthetics
Description
Based on a visual analogue scale (VAS), measured as numbers from 0 (lowest) to 10 (highest).
Time Frame
Measured at baseline and at 6 months, and compared between these time points to provide subjective esthetic results
Title
Patient-reported satisfaction
Description
Based on a visual analogue scale (VAS), measured as numbers from 0 (lowest) to 10 (highest).
Time Frame
Measured at 6 months to provide the satisfaction score in VAS scale
Title
Patient-reported post-operative pain as measured with a mobile application
Description
Measured using a mobile application at the recession grafted site, the donor site on the palate, and the donor site for the venopuncture.
Time Frame
From the day of the procedure until 1 month after the surgical time point

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hom-Lay Wang, DDS MSD PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shayan Barootchi, DMD, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan - Ann Arbor
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35175005
Citation
Barootchi S, Tavelli L. Tunneled coronally advanced flap for the treatment of isolated gingival recessions with deficient papilla. Int J Esthet Dent. 2022 Feb 17;17(1):14-26.
Results Reference
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PubMed Identifier
35665500
Citation
Barootchi S, Giannobile WV, Tavelli L. PDGF-BB-enriched collagen matrix to treat multiple gingival recessions with the tunneled coronally advanced flap. Clin Adv Periodontics. 2022 Dec;12(4):224-232. doi: 10.1002/cap.10211. Epub 2022 Oct 24.
Results Reference
background
PubMed Identifier
35353081
Citation
Tavelli L, Barootchi S. A Minimally Invasive Approach for the Treatment of Multiple Adjacent Gingival Recessions with a Volume-Stable Collagen Matrix: A Case Series. Int J Periodontics Restorative Dent. 2022 Mar-Apr;42(2):155-162. doi: 10.11607/prd.5747.
Results Reference
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Treatment of Gingival Recession Defects Using Platelet-Rich Fibrin With an Allogenic Dermal Matrix

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