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

Gingival Recession Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05819515
• Other study ID #: HUM00214311
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 29, 2023
• Est. completion date: September 2024

Study information

• Verified date: August 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Tunneled coronally advanced flap
Describes the flap design for both treatment arms

Locations

Country	Name	City	State
United States	University of Michigan - Ann Arbor	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean root coverage (mRC)	Measured as a percentage of the total baseline recession defect that coverage was obtained at.	Assessed at 6 months
Primary	Complete root coverage (CRC)	Measured as a percentage of total treated sites, that obtained a full coverage of the recession defect	Assessed at 6 months
Primary	Keratinized tissue (KT) gain	Measured in mm	Assessed at 6 months
Primary	Gingival thickness (GT) gain	Measured in mm	Assessed at 6 months
Primary	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).	Measured from the day of the procedure up to a maximum of 1 month
Primary	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.	During surgery
Secondary	Professionally evaluated esthetic score	Assessed using the Root coverage Esthetic Score (RES) system (from 0 lowest, to 10 highest)	Assessed at 6 months
Secondary	Soft tissue volume changes over time	Assessed using 3D scanner imaging in the units of mm	Changes of from baseline (prior to treatment) compared with 3 and 6 months
Secondary	Soft tissue volume changes over time	Assessed using dental ultrasonography in the units of mm	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
Secondary	Soft tissue blood flow changes over time	Assessed and quantified using dental ultrasonography	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
Secondary	Patient-reported esthetics	Based on a visual analogue scale (VAS), measured as numbers from 0 (lowest) to 10 (highest).	Measured at baseline and at 6 months, and compared between these time points to provide subjective esthetic results
Secondary	Patient-reported satisfaction	Based on a visual analogue scale (VAS), measured as numbers from 0 (lowest) to 10 (highest).	Measured at 6 months to provide the satisfaction score in VAS scale
Secondary	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.	From the day of the procedure until 1 month after the surgical time point