NCT05267015

Brief Summary

This is a split-mouth, randomized, controlled clinical trial that aims to evaluate the clinical efficacy of platelet-rich fibrin (PRF) membranes in conjunction with coronally advanced flap (CAF) in treating maxillary gingival recession defects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

February 14, 2022

Last Update Submit

February 23, 2022

Conditions

Gingival Recession

Keywords

connective tissue graftPRF membranegingival recession

Outcome Measures

Primary Outcomes (2)

  • Increase in gingival height (recession coverage)

    The measurements of the increase in gingival height (recession coverage) using a linear evaluation (corono-apical direction) with a periodontal probe (Merrit-B; Hu-Friedy, Chicago, IL, USA) at the interventions sites to the nearest 0.5 mm. Registration of the recession height was done before treatment and after 6 weeks.

    six weeks

  • Shrinkage in gingival height

    To assess the shrinkage of the gingival height, the amount of gingival height vestibular to the treated teeth in a corono-apical direction was measured after the surgery and after six months.

    six months

Secondary Outcomes (1)

  • Postoperative pain visual analog scores (VAS) and surgery time

    two weeks

Study Arms (2)

coronally advanced flap with connective tissue graft

ACTIVE COMPARATOR

After randomization a subepithelial connective tissue graft along with coronally advanced flap is applied to one maxillary quadrant to cover the recession.

Procedure: Gingival coverage using coronally advanced flap and a connective tissue graft

coronally advanced flap with platelet rich fibrin membranes

EXPERIMENTAL

After randomization platelet rich fibrin membranes along with coronally advanced flap are applied to the other maxillary quadrant to cover the recession.

Procedure: Gingival coverage using coronally advanced flap and platelet rich fibrin membranes

Interventions

Gingival coverage using coronally advanced flap and a connective tissue graftPROCEDURE

A coronally advanced flap is applied for recession coverage in the maxilla in a split-mouth randomized trial using a subepithelial connective tissue graft

coronally advanced flap with connective tissue graft
Gingival coverage using coronally advanced flap and platelet rich fibrin membranesPROCEDURE

A coronally advanced flap is applied for recession coverage in the maxilla in a split-mouth randomized trial using platelet rich fibrin membranes

coronally advanced flap with platelet rich fibrin membranes

Eligibility Criteria

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

You may qualify if:

  • Greater than 18 years old
  • Bilateral Miller class I + II recession in the upper jaw

You may not qualify if:

  • Smokers
  • Patients with systemic diseases that could interfere with the healing
  • Patients undergoing bisphosphonate therap .Patients who previously received radiation therapy of the jaws.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arab American University

Ramallah, 240, Palestinian Territories

Location

Related Publications (1)

  • Abu-Ta'a M. Advanced Platelet-Rich Fibrin and Connective Tissue Graft for Treating Marginal Tissue Recessions: A Randomized, Controlled Split-Mouth Study. Cureus. 2023 Mar 4;15(3):e35761. doi: 10.7759/cureus.35761. eCollection 2023 Mar.

    PMID: 36879584DERIVED

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Mahmoud F Abu-Ta'a, Periodontist

    Head of Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 14, 2022

First Posted

March 4, 2022

Study Start

January 3, 2021

Primary Completion

August 15, 2021

Study Completion

November 14, 2021

Last Updated

March 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)