Back to resultsClinical Evaluation of Injectable Platelet Rich Fibrin With Connective Tissue Graft for the Treatment of Deep Gingival Recession Defects.
Primary Purpose
Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
CAF+CTG+i-prf
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring connective tissue graft
Eligibility Criteria
Inclusion Criteria:
- ≥19 years of age,
- Periodontally and systemically healthy,
- FMPS and FMBS <15%,
- Presence of deep Miller class I and II gingival recession defect (≥3 mm in depth) at the buccal aspect of incisors,
Exclusion Criteria:
Smoking,
- Contraindications for surgery,
- Presence of recession defects associated with caries, deep abrasion, restoration or pulpal pathology.
Sites / Locations
- Cukurova University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CAF+CTG
CAF+CTG+i-prf
Arm Description
the combined connective tissue graft (CTG) with coronally advanced flap (CAF)
the combined connective tissue graft (CTG) and injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF)
Outcomes
Primary Outcome Measures
gingival recession depth
the distance between the CEJ and gingival margin-measurements were performed at the midbuccal aspect of the teeth, by manual probe and were rounded up to the nearest millimetre
Keratized tissue height
measured from the mucogingival junction to the gingival margin-measurements were performed at the midbuccal aspect of the teeth, by manual probe and were rounded up to the nearest millimetre
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04032405
Brief Title
Clinical Evaluation of Injectable Platelet Rich Fibrin With Connective Tissue Graft for the Treatment of Deep Gingival Recession Defects.
Official Title
Clinical Evaluation of Injectable Platelet Rich Fibrin With Connective Tissue Graft for the Treatment of Deep Gingival Recession Defects. A Controlled Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
September 25, 2018 (Actual)
Study Completion Date
March 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aim: The aim of this study was to determine whether the combined connective tissue graft (CTG) with injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF) improved root coverage of deep Miller Class I or II gingival recessions compared to CTG alone with CAF.
Methods: Seventy-two patients with Miller class I and II gingival recessions were enrolled. Thirty-six patients were randomly assigned to the test group (CAF+CTG+i-prf) or control group (CAF+CTG). Clinical evaluations were made at 6 months
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAF+CTG
Arm Type
Active Comparator
Arm Description
the combined connective tissue graft (CTG) with coronally advanced flap (CAF)
Arm Title
CAF+CTG+i-prf
Arm Type
Experimental
Arm Description
the combined connective tissue graft (CTG) and injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF)
Intervention Type
Procedure
Intervention Name(s)
CAF+CTG+i-prf
Intervention Description
combined connective tissue graft (CTG) and injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF)
Primary Outcome Measure Information:
Title
gingival recession depth
Description
the distance between the CEJ and gingival margin-measurements were performed at the midbuccal aspect of the teeth, by manual probe and were rounded up to the nearest millimetre
Time Frame
six months
Title
Keratized tissue height
Description
measured from the mucogingival junction to the gingival margin-measurements were performed at the midbuccal aspect of the teeth, by manual probe and were rounded up to the nearest millimetre
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
≥19 years of age,
Periodontally and systemically healthy,
FMPS and FMBS <15%,
Presence of deep Miller class I and II gingival recession defect (≥3 mm in depth) at the buccal aspect of incisors,
Exclusion Criteria:
Smoking,
Contraindications for surgery,
Presence of recession defects associated with caries, deep abrasion, restoration or pulpal pathology.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
onur ucak Turer
Organizational Affiliation
CukurovaU Prof.
Official's Role
Study Director
Facility Information:
Facility Name
Cukurova University
City
Adana
State/Province
Balcalı
ZIP/Postal Code
01130
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of Injectable Platelet Rich Fibrin With Connective Tissue Graft for the Treatment of Deep Gingival Recession Defects.
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