search
Back to results

Platelet-Rich Fibrin Prepared With Titanium in the Treatment of Multiple Gingival Recessions

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
COMPARISON OF PLATELET-RICH FIBRIN PREPARED WITH TITANIUM AND SUBEPITHELIAL CONNECTIVE TISSUE GRAFT
Sponsored by
Necmettin Erbakan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Gingival Recession focused on measuring recession, gingival, subepithelial connective tissue graft

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The criteria for inclusion in the study were determined as systemically and periodontally healthy volunteers between the ages of 18-65,
  • the absence of parafunctional habits, non-smoking
  • the presence of Miller Class I gingival recession defect in teeth located in the bilateral maxillary region
  • the absence of any hard tissue defects in the relevant region and the absence of a restorative, endodontic procedure or periodontal surgical intervention
  • a full-mouth plaque score (FMPS) of ≤ 25%
  • having a marginal gingival thickness of at least 1 mm in the area with gingival recession
  • the absence of a shallow hard palate dome
  • having a soft tissue thickness of at least 3 mm
  • the absence of torus in the area where the graft was taken
  • the absence of any systemic disease
  • not using antibiotics for any reason in the last 6 months
  • the presence of at least 20 teeth in the mouth
  • not being pregnant and breastfeeding, and patients who applied to the periodontology clinic with various periodontal problems and were indicated for connective tissue graft operation due to gingival recession

Exclusion Criteria:

  • The individuals who were outside the exclusion criteria and did not agree to participate in the study were excluded from the study.

Sites / Locations

  • Necmettin Erbakan Üniversitesi Diş Hekimliği Fakültesi
  • Necmettin Erbakan Üniversitesi Diş Hekimliği Fakültesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Groups

Test Group

Arm Description

Control groups. This clinical trial was designed as a split-mouth, randomized, controlled clinical trial. Bilateral gingival recession defects were randomly assigned to the test (CAF+T-PRF) or control (CAF+SCTG) groups after initially evaluating the clinical parameters and randomized by coin flip method. Intervention: Procedure: Control groups

Test groups. This clinical trial was designed as a split-mouth, randomized, controlled clinical trial. Bilateral gingival recession defects were randomly assigned to the test (CAF+T-PRF) or control (CAF+SCTG) groups after initially evaluating the clinical parameters and randomized by coin flip method. Intervention: Procedure: Control groups Intervention: Procedure: test groups

Outcomes

Primary Outcome Measures

Complete root coverage [ Time Frame: 6 months
Change from baseline in gingival recession was be assessed at 1, and 6 months.
Gingival recession depth [ Time Frame: 6 months ]
Change from baseline in gingival recession was be assessed at 6 months

Secondary Outcome Measures

Keratinized tissue width [ Time Frame: 6 months ]
Change from baseline in keratinized tissue at 6 months.
Pain scores [ Time Frame: first week after operations ]
Pain level evaluated on visual analog scale

Full Information

First Posted
February 12, 2022
Last Updated
February 26, 2022
Sponsor
Necmettin Erbakan University
search

1. Study Identification

Unique Protocol Identification Number
NCT05270941
Brief Title
Platelet-Rich Fibrin Prepared With Titanium in the Treatment of Multiple Gingival Recessions
Official Title
Platelet Rich Fibrin Prepared With Titanium Connective Tissue Graft in Treatment of Gingival Recessions
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 12, 2019 (Actual)
Primary Completion Date
November 29, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study was to treat the areas with Miller Class I bilateral multiple gingival recession in the maxillary teeth using the Titanium Platelet-Rich Fibrin (T-PRF), an autogenous biomaterial applied in combination with a Modified Coronally Positioned Flap (MCPF) prepared using microsurgical techniques, and the gold standard Subepithelial Connective Tissue Graft (SCTG), to evaluate the efficacy of the treatments and to compare the clinical results 6 months after the treatment.
Detailed Description
AİM: The aim of this study was to treat the areas with Miller Class I bilateral multiple gingival recession in the maxillary teeth using the Titanium Platelet-Rich Fibrin (T-PRF), an autogenous biomaterial applied in combination with a Modified Coronally Positioned Flap (MCPF) prepared using microsurgical techniques, and the gold standard Subepithelial Connective Tissue Graft (SCTG), to evaluate the efficacy of the treatments and to compare the clinical results 6 months after the treatment. MATERIALS AND METHODS A total of 20 patients (118 defects), consisting of 13 females and 7 males, with maxillary bilateral Miller Class I gingival recession who were aged between 18 and 65, applied to Necmettin Erbakan University, Faculty of Dentistry, Department of Periodontology and had aesthetic anxiety and sensitivity problems due to multiple gingival recessions were included in our study. As a randomized controlled clinical trial, in the patients' bilateral recession sites, while gingival recessions of one group were treated with T-PRF, the gingival recessions of the other group were treated with SCTG using a simple randomization method. The study protocol was in accordance with the Declaration of Helsinki of 1975, as revised in 2002 and was submitted to and approved by the ethical committee of Necmettin Erbakan University and the Ministry of Health General Directorate of Health Services (protocol number:2019/238). All patients included in the study were given detailed information about the clinical trial, and their written informed consent was obtained. The study was performed between January 2019 and November 2020 in Necmettin Erbakan University Department of Periodontology. The individuals were divided into 2 groups in accordance with the study protocol: Group1: SCTG group (n=60) Group2: T-PRF group (n=58) The criteria for inclusion in the study were determined as systemically and periodontally healthy volunteers between the ages of 18-65, the absence of parafunctional habits, non-smoking, the presence of Miller Class I gingival recession defect in teeth located in the bilateral maxillary region, the absence of any hard tissue defects in the relevant region and the absence of a restorative, endodontic procedure or periodontal surgical intervention, a full-mouth plaque score (FMPS) of ≤ 25%, having a marginal gingival thickness of at least 1 mm in the area with gingival recession, the absence of a shallow hard palate dome, having a soft tissue thickness of at least 3 mm, the absence of torus in the area where the graft was taken, the absence of any systemic disease, not using antibiotics for any reason in the last 6 months, the presence of at least 20 teeth in the mouth, not being pregnant and breastfeeding, and patients who applied to the periodontology clinic with various periodontal problems and were indicated for connective tissue graft operation due to gingival recession. The individuals who were outside the exclusion criteria and did not agree to participate in the study were excluded from the study. In the study with a sample size of 118, the effect size value (G * Power 3.1 for Windows) calculated based on the power (1-β err probe) = 95% and α = 5% t-test was determined as 0.334 for the analysis of repeated measurements.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
As a randomized controlled clinical trial, in the patients' bilateral recession sites, while gingival recessions of one group were treated with T-PRF, the gingival recessions of the other group were treated with SCTG using a simple randomization method.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Groups
Arm Type
Active Comparator
Arm Description
Control groups. This clinical trial was designed as a split-mouth, randomized, controlled clinical trial. Bilateral gingival recession defects were randomly assigned to the test (CAF+T-PRF) or control (CAF+SCTG) groups after initially evaluating the clinical parameters and randomized by coin flip method. Intervention: Procedure: Control groups
Arm Title
Test Group
Arm Type
Experimental
Arm Description
Test groups. This clinical trial was designed as a split-mouth, randomized, controlled clinical trial. Bilateral gingival recession defects were randomly assigned to the test (CAF+T-PRF) or control (CAF+SCTG) groups after initially evaluating the clinical parameters and randomized by coin flip method. Intervention: Procedure: Control groups Intervention: Procedure: test groups
Intervention Type
Procedure
Intervention Name(s)
COMPARISON OF PLATELET-RICH FIBRIN PREPARED WITH TITANIUM AND SUBEPITHELIAL CONNECTIVE TISSUE GRAFT
Other Intervention Name(s)
MODİFİYE CORONALLY ADVANCED FLAP
Intervention Description
In the study, 118 maxillary bilateral multiple Miller Class I gingival recessions in 20 patients were treated. The gingival recessions were randomly treated with either T-PRF (58 teeth) or SCTG (60 teeth) using the modified coronally positioned flap technique. Gingival index, plaque index, probing pocket depth, gingival thickness, recession height, recession width, keratinized gingival width, and open root surface area were measured and recorded at baseline and at the 6th month. Postoperative pain levels were evaluated using the VAS (Visual Analogue Scale), and healing status was evaluated using the wound healing index. The pre- and post-treatment results of both treatment groups and the differences between the groups were evaluated and compared.
Primary Outcome Measure Information:
Title
Complete root coverage [ Time Frame: 6 months
Description
Change from baseline in gingival recession was be assessed at 1, and 6 months.
Time Frame
6 MONTHS
Title
Gingival recession depth [ Time Frame: 6 months ]
Description
Change from baseline in gingival recession was be assessed at 6 months
Time Frame
6 months.
Secondary Outcome Measure Information:
Title
Keratinized tissue width [ Time Frame: 6 months ]
Description
Change from baseline in keratinized tissue at 6 months.
Time Frame
6 months.
Title
Pain scores [ Time Frame: first week after operations ]
Description
Pain level evaluated on visual analog scale
Time Frame
first week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The criteria for inclusion in the study were determined as systemically and periodontally healthy volunteers between the ages of 18-65, the absence of parafunctional habits, non-smoking the presence of Miller Class I gingival recession defect in teeth located in the bilateral maxillary region the absence of any hard tissue defects in the relevant region and the absence of a restorative, endodontic procedure or periodontal surgical intervention a full-mouth plaque score (FMPS) of ≤ 25% having a marginal gingival thickness of at least 1 mm in the area with gingival recession the absence of a shallow hard palate dome having a soft tissue thickness of at least 3 mm the absence of torus in the area where the graft was taken the absence of any systemic disease not using antibiotics for any reason in the last 6 months the presence of at least 20 teeth in the mouth not being pregnant and breastfeeding, and patients who applied to the periodontology clinic with various periodontal problems and were indicated for connective tissue graft operation due to gingival recession Exclusion Criteria: The individuals who were outside the exclusion criteria and did not agree to participate in the study were excluded from the study.
Facility Information:
Facility Name
Necmettin Erbakan Üniversitesi Diş Hekimliği Fakültesi
City
Konya
State/Province
Meram
ZIP/Postal Code
42050
Country
Turkey
Facility Name
Necmettin Erbakan Üniversitesi Diş Hekimliği Fakültesi
City
Konya
ZIP/Postal Code
42050
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Platelet-Rich Fibrin Prepared With Titanium in the Treatment of Multiple Gingival Recessions

We'll reach out to this number within 24 hrs