NCT05819515

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

April 29, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2024

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

11 months

First QC Date

March 21, 2023

Last Update Submit

July 10, 2024

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (6)

  • Mean root coverage (mRC)

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

    Assessed at 6 months

  • 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

  • Keratinized tissue (KT) gain

    Measured in mm

    Assessed at 6 months

  • Gingival thickness (GT) gain

    Measured in mm

    Assessed at 6 months

  • 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

  • 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 Outcomes (7)

  • Professionally evaluated esthetic score

    Assessed at 6 months

  • Soft tissue volume changes over time

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

  • Soft tissue volume changes over time

    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

  • Soft tissue blood flow changes over time

    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

  • Patient-reported esthetics

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

  • +2 more secondary outcomes

Study Arms (2)

Connective Tissue Graft

ACTIVE COMPARATOR

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

Procedure: Tunneled coronally advanced flap

Allogenic Dermal Matrix with Platelet-Rich Fibrin

EXPERIMENTAL

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

Procedure: Tunneled coronally advanced flap

Interventions

Tunneled coronally advanced flapPROCEDURE

Describes the flap design for both treatment arms

Allogenic Dermal Matrix with Platelet-Rich FibrinConnective Tissue Graft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan - Ann Arbor

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (3)

  • 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.

    PMID: 35175005BACKGROUND

  • 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.

    PMID: 35665500BACKGROUND

  • 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.

    PMID: 35353081BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Hom-Lay Wang, DDS MSD PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Shayan Barootchi, DMD, MS

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 21, 2023

First Posted

April 19, 2023

Study Start

April 29, 2023

Primary Completion

March 27, 2024

Study Completion

March 27, 2024

Last Updated

July 12, 2024

Record last verified: 2024-07

Locations

US(1)