search
Back to results

Platelet Rich Fibrin in the Treatment of Localized Gingival Recessions

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Subepithelial connective tissue graft
Platelet Rich Fibrin
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring gingival recession, fibrin, connective tissue, root coverage, microsurgery, case-control studies

Eligibility Criteria

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

Inclusion Criteria:

  • Similar bilateral or contralateral Miller Class I or II localized gingival recessions at least ≥ 2 mm located on incisors, canines or premolars on both jaws
  • Identifiable CEJ
  • Age ≥ 18 years
  • Presence of tooth vitality and absence of restorations and superficial caries in the area to be treated
  • No periodontal surgical treatment in the previous 24 months on the involved sites
  • Gingival thickness at least ≥ 0.8 mm for the recession area
  • Sufficient palatal donor tissue for the indicated SCTG.

Exclusion Criteria:

  • Smoking
  • Patients with a pregnancy or lactation period or self-reported history of antibiotic medication within three months
  • Molar, mobile or teeth with crown or filling were also excluded.

Sites / Locations

  • Ege University School of Dentistry Department of Periodontology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Subepithelial connective tissue graft

Platelet Rich Fibrin

Arm Description

Soft tissue harvested from palatum of the subjects.

Autogenous platelet and leukocyte fibrin material was obtained from blood.

Outcomes

Primary Outcome Measures

Complete root coverage
Change from baseline in percentage of complete root coverage at 1, 3 and 6 months.
Gingival recession depth
Change from baseline in gingival recession will be assessed at 1, 3 and 6 months.

Secondary Outcome Measures

Keratinized tissue width
Change from baseline in keratinized tissue at 6 months.
Gingival thickness
Change from baseline in gingival thickness at 6 months

Full Information

First Posted
February 12, 2013
Last Updated
August 14, 2013
Sponsor
Ege University
search

1. Study Identification

Unique Protocol Identification Number
NCT01793389
Brief Title
Platelet Rich Fibrin in the Treatment of Localized Gingival Recessions
Official Title
Platelet Rich Fibrin in the Treatment of Localized Gingival Recessions: Split-mouth Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The present study deals with treatment of localized gingival recessions. The hypothesis of this study is that platelet rich fibrin can be used an alternative to subepithelial connective tissue graft in the coverage of denuded roots. If the platelet rich fibrin will prove to be similarly effective as subepithelial connective tissue graft, it will be possible to avoid a donor site and to decrease patient discomfort after operation.
Detailed Description
The main objective of this split-mouth, randomized, controlled clinical trial was to compare the clinical efficacy of platelet rich fibrin (PRF) in combination with the coronally advanced flap (CAF) to the use of subepithelial connective tissue graft (SCTG) in combination with CAF in the treatment of localized gingival recessions. Primary outcome variables were percentage of complete root coverage and change in gingival recession expressed as recession reduction in millimeters at follow-up visits. The secondary outcome variables included keratinized tissue and gingival thickness gain. Sample size has been estimated in 22 subjects per treatment groups. Random allocation of the treatment sites to test (CAF+ PRF) and control (CAF + SCTG) groups will be performed using a computerized selection of random numbers for allocation of the study groups. Periodontal parameters including plaque index (25) (PI), gingival index (26) (GI), probing depth (PD), clinical attachment level (CAL), and gingival recession parameters including recession depth (RD), recession width (RW), recession area (RA), keratinized tissue width (KTW), gingival thickness (GT) were assessed by a calibrated examiner. At baseline and 1, 3 and 6 months, RD, RW, RA, KTW were evaluated by means of both clinical and digital assessment. GI and PI were recorded at baseline and 1, 3 and 6 months, however PD, CAL, and GT were evaluated at baseline and 6 months. PD and CAL were recorded by a Williams probe accurate to the nearest 0.5 mm. GT was evaluated at baseline and 6 months using #15 endodontic reamer attached to a rubber stopper inserted perpendicularly into the gingival tissue 2 mm below the gingival margin; thickness was measured to the nearest 0.1 mm using a caliper. Clinical images obtained at baseline and 1, 3 and 6 months after surgery from each treatment site and digitized in a computer image analysis system. Using a 4-mm length wire was used to check the reproducibility of the pictures. RD was measured from the cement-enamel junction (CEJ) to the gingival margin, RW was measured tangentially at the mid-facial CEJ, RA was calculated as the area within the contour of denuded root. KTW recorded as the distance from the mucogingival junction (MGJ) to the gingival margin. Duplicate measurements were made for RD, RW, RA and KTW. Percent root coverage and complete root coverage was calculated RA according to the following standard formulae. Follow-up of subjects will be 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
gingival recession, fibrin, connective tissue, root coverage, microsurgery, case-control studies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subepithelial connective tissue graft
Arm Type
Active Comparator
Arm Description
Soft tissue harvested from palatum of the subjects.
Arm Title
Platelet Rich Fibrin
Arm Type
Experimental
Arm Description
Autogenous platelet and leukocyte fibrin material was obtained from blood.
Intervention Type
Procedure
Intervention Name(s)
Subepithelial connective tissue graft
Intervention Type
Procedure
Intervention Name(s)
Platelet Rich Fibrin
Primary Outcome Measure Information:
Title
Complete root coverage
Description
Change from baseline in percentage of complete root coverage at 1, 3 and 6 months.
Time Frame
1, 3 and 6 months
Title
Gingival recession depth
Description
Change from baseline in gingival recession will be assessed at 1, 3 and 6 months.
Time Frame
1, 3 and 6 months
Secondary Outcome Measure Information:
Title
Keratinized tissue width
Description
Change from baseline in keratinized tissue at 6 months.
Time Frame
6 months
Title
Gingival thickness
Description
Change from baseline in gingival thickness at 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Similar bilateral or contralateral Miller Class I or II localized gingival recessions at least ≥ 2 mm located on incisors, canines or premolars on both jaws Identifiable CEJ Age ≥ 18 years Presence of tooth vitality and absence of restorations and superficial caries in the area to be treated No periodontal surgical treatment in the previous 24 months on the involved sites Gingival thickness at least ≥ 0.8 mm for the recession area Sufficient palatal donor tissue for the indicated SCTG. Exclusion Criteria: Smoking Patients with a pregnancy or lactation period or self-reported history of antibiotic medication within three months Molar, mobile or teeth with crown or filling were also excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülnihal Eren, PhD
Organizational Affiliation
Ege University School of Dentistry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gül Atilla, Professor
Organizational Affiliation
Ege University School of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Ege University School of Dentistry Department of Periodontology
City
İzmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Platelet Rich Fibrin in the Treatment of Localized Gingival Recessions

We'll reach out to this number within 24 hrs