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PRF for Treating Maxillary Gingival Recession

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Palestinian Territory, occupied
Study Type
Interventional
Intervention
Gingival coverage using coronally advanced flap and a connective tissue graft
Gingival coverage using coronally advanced flap and platelet rich fibrin membranes
Sponsored by
Arab American University (Palestine)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring connective tissue graft, PRF membrane, gingival recession

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Arab American University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

coronally advanced flap with connective tissue graft

coronally advanced flap with platelet rich fibrin membranes

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Postoperative pain visual analog scores (VAS) and surgery time
This questionnaire used 100 mm visual analog scores VAS to evaluate the amount of pain, ranging from 0 (no pain) to 10 (worst pain imaginable), and the amount of swelling. Patients were asked to fill in the VAS scales at day 7 and day 14 at suture removal. The time of surgery was measured of both treatment options. Timing started at the moment of first incision until the last suture.

Full Information

First Posted
February 14, 2022
Last Updated
February 23, 2022
Sponsor
Arab American University (Palestine)
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1. Study Identification

Unique Protocol Identification Number
NCT05267015
Brief Title
PRF for Treating Maxillary Gingival Recession
Official Title
PRF for Treating Maxillary Gingival Recessions: A Split-mouth, Randomized, Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 3, 2021 (Actual)
Primary Completion Date
August 15, 2021 (Actual)
Study Completion Date
November 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arab American University (Palestine)

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
connective tissue graft, PRF membrane, gingival recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
coronally advanced flap with connective tissue graft
Arm Type
Active Comparator
Arm Description
After randomization a subepithelial connective tissue graft along with coronally advanced flap is applied to one maxillary quadrant to cover the recession.
Arm Title
coronally advanced flap with platelet rich fibrin membranes
Arm Type
Experimental
Arm Description
After randomization platelet rich fibrin membranes along with coronally advanced flap are applied to the other maxillary quadrant to cover the recession.
Intervention Type
Procedure
Intervention Name(s)
Gingival coverage using coronally advanced flap and a connective tissue graft
Intervention Description
A coronally advanced flap is applied for recession coverage in the maxilla in a split-mouth randomized trial using a subepithelial connective tissue graft
Intervention Type
Procedure
Intervention Name(s)
Gingival coverage using coronally advanced flap and platelet rich fibrin membranes
Intervention Description
A coronally advanced flap is applied for recession coverage in the maxilla in a split-mouth randomized trial using platelet rich fibrin membranes
Primary Outcome Measure Information:
Title
Increase in gingival height (recession coverage)
Description
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.
Time Frame
six weeks
Title
Shrinkage in gingival height
Description
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.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Postoperative pain visual analog scores (VAS) and surgery time
Description
This questionnaire used 100 mm visual analog scores VAS to evaluate the amount of pain, ranging from 0 (no pain) to 10 (worst pain imaginable), and the amount of swelling. Patients were asked to fill in the VAS scales at day 7 and day 14 at suture removal. The time of surgery was measured of both treatment options. Timing started at the moment of first incision until the last suture.
Time Frame
two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Greater than 18 years old Bilateral Miller class I + II recession in the upper jaw Exclusion Criteria: Smokers Patients with systemic diseases that could interfere with the healing Patients undergoing bisphosphonate therap .Patients who previously received radiation therapy of the jaws.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud F Abu-Ta'a, Periodontist
Organizational Affiliation
Head of Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arab American University
City
Ramallah
ZIP/Postal Code
240
Country
Palestinian Territory, occupied

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PRF for Treating Maxillary Gingival Recession

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