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Platelet-Rich Fibrin in the Treatment of Multiple Gingival Recessions

Primary Purpose

Gingival Recessions

Status
Completed
Phase
Early Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
test groups
Control groups
Sponsored by
Necmettin Erbakan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recessions focused on measuring Platelet rich fibrin, Gingival Recession

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • non smoking,
  • similar bilateral Miller Class I or II20 localized gingival recessions at least ≥3 mm, located on incisors, canines or premolars on both jaws,
  • identifiable cemento-enamel junction (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 on the involved sites,
  • sufficient palatal donor tissue at least ≥2.5 mm thickness for the indicated SCTG

Exclusion Criteria:

  • Patients in a pregnancy or lactation period or with self-reported history of antibiotic medication within 6 months
  • Molar, mobile or fully restorated teeth

Sites / Locations

  • NEU Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test groups.

Control groups.

Arm Description

This clinical study was designed as a split-mouth, randomized, controlled clinical trial. Bilateral gingival recession defects were randomly assigned to the test (CAF+PRF) or the control (CAF+SCTG) groups with the use of computer-generated randomization table after assessment of clinical parameters at baseline.

This clinical study was designed as a split-mouth, randomized, controlled clinical trial. Bilateral gingival recession defects were randomly assigned to the test (CAF+PRF) or the control (CAF+SCTG) groups with the use of computer-generated randomization table after assessment of clinical parameters at baseline.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Keratinized tissue width
Change from baseline in keratinized tissue at 6 months.
Pain scores
Pain level evaluated on visual analog scale

Full Information

First Posted
December 13, 2014
Last Updated
January 7, 2015
Sponsor
Necmettin Erbakan University
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1. Study Identification

Unique Protocol Identification Number
NCT02335866
Brief Title
Platelet-Rich Fibrin in the Treatment of Multiple Gingival Recessions
Official Title
Platelet Rich Fibrin Against Connective Tissue Graft in Treatment of Gingival Recessions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main objective of this study was to evaluate the clinical effectiveness of platelet-rich fibrin membrane used in combination with a coronally advanced flap and to compare it with the use of a subepitelial connective tissue graft in combination with a coronally advanced flap in Miller class I-II bilateral gingival recession treatment
Detailed Description
Purpose The main objective of this study was to evaluate the clinical effectiveness of platelet-rich fibrin (PRF) in combination with modified coronally advanced flap (MCAF) in the treatment of multiple gingival recessions. Furthermore the second aim of the present study was to compare plastic periodontal surgical procedure, with PRF membrane and connective tissue graft, by a randomized splitmouth controlled study. Clinical effectiveness of platelet-rich fibrin (PRF) in combination with modified coronally advanced flap (MCAF) as measured by Clinical measurements. Material and Methods Twenty patients with multiple gingival recession defects (Miller I, II) participated in this split-mouth trial. Sixty defects received either MCAF+PRF (test) or MCAF with subepithelial connective tissue graft (SCTG) (control). Gingival recession depth (RD), gingival recession width (RW), keratinized tissue width (KTW), recession area (RA), probing depth (PD), clinical attachment level (CAL) and gingival thickness (GT) were evaluated at baseline and 6 months. Additionally post-surgery patient satisfaction and pain status were measured by comparing visual analogue scale (VAS) scores. Clinical measurements were taken at starting point and 6 months postoperatively. The measurements comprised an assessment of probing depth (PD),clinical attachment level (CAL) and gingival recession parameters including recession depth (RD), recession width (RW), keratinized tissue width (KTW) and gingival thickness (GT) were assessed by a calibrated examiner (E. Ö.). PD, CAL, RD, RW and KTW values were recorded by a Williams probe graduated in 1-mm increments and rounded up to the nearest millimeter (Hu Friedy, Chicago, IL, USA). To standardize the clinical measurements acrylic stents were prepared on patients' casts. The following measurements were recorded at the mid-buccal point of the teeth at baseline and6 months after surgery. GT was evaluated using endodontic reamer attached to a rubber stopper inserted perpendicularly into the gingival tissue 3 mm below the gingival margin under local anesthesia, and then the thickness was measured to the nearest 0.1 mm using a caliper.RD was measured from the CEJ to the gingival margin, RW was measured tangentially at the mid-facial CEJ and RA was calculated as the area within the contour of denuded root. KTW recorded as the distance from the mucogingival junction to the gingival margin. Duplicate measurements were made for RD, RW, RA and KTW with an interval of 24 hours and the average value of two measurements was used for the assessment. The postoperative pain was evaluated with a visual analog score (VAS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recessions
Keywords
Platelet rich fibrin, Gingival Recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test groups.
Arm Type
Experimental
Arm Description
This clinical study was designed as a split-mouth, randomized, controlled clinical trial. Bilateral gingival recession defects were randomly assigned to the test (CAF+PRF) or the control (CAF+SCTG) groups with the use of computer-generated randomization table after assessment of clinical parameters at baseline.
Arm Title
Control groups.
Arm Type
Active Comparator
Arm Description
This clinical study was designed as a split-mouth, randomized, controlled clinical trial. Bilateral gingival recession defects were randomly assigned to the test (CAF+PRF) or the control (CAF+SCTG) groups with the use of computer-generated randomization table after assessment of clinical parameters at baseline.
Intervention Type
Procedure
Intervention Name(s)
test groups
Other Intervention Name(s)
PRF groups
Intervention Description
At the test sites, the previously prepared PRF was positioned over the recession defects, the coronal margin of the PRF was placed at the CEJ
Intervention Type
Procedure
Intervention Name(s)
Control groups
Other Intervention Name(s)
Connective tissue graft groups
Intervention Description
Split-full-split thickness flap incisions were performed in a coronal-apical direction. The papillae adjacent to the involved tooth were de-epithelialized to create a connective tissue bed. The gingival flap was repositioned without tension, with its margin located on the enamel, on the test and control sides. It was held in that position with 5-0 resoble sutures
Primary Outcome Measure Information:
Title
Complete root coverage
Description
Change from baseline in gingival recession will be assessed at 1, 3 and 6 months.
Time Frame
6 months
Title
Gingival recession depth
Description
Change from baseline in gingival recession will be assessed at 6 months
Time Frame
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
Pain scores
Description
Pain level evaluated on visual analog scale
Time Frame
first week after operations

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: non smoking, similar bilateral Miller Class I or II20 localized gingival recessions at least ≥3 mm, located on incisors, canines or premolars on both jaws, identifiable cemento-enamel junction (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 on the involved sites, sufficient palatal donor tissue at least ≥2.5 mm thickness for the indicated SCTG Exclusion Criteria: Patients in a pregnancy or lactation period or with self-reported history of antibiotic medication within 6 months Molar, mobile or fully restorated teeth
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ELİF ÖNCÜ, PhD
Organizational Affiliation
NECMETTİN ERBAKAN UNIVERSITY
Official's Role
Study Director
Facility Information:
Facility Name
NEU Dental School
City
Konya
ZIP/Postal Code
42060
Country
Turkey

12. IPD Sharing Statement

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Platelet-Rich Fibrin in the Treatment of Multiple Gingival Recessions

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