Clinical Evaluation of Injectable Platelet Rich Fibrin With Connective Tissue Graft for the Treatment of Deep Gingival Recession Defects.

Clinical Evaluation of Injectable Platelet Rich Fibrin With Connective Tissue Graft for the Treatment of Deep Gingival Recession Defects. A Controlled Randomized Clinical Trial.

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

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: CAF+CTG+i-prf

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Balcalı
    • Adana, Balcalı, Turkey, 01130
      • Çukurova University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CAF+CTG; the combined connective tissue graft (CTG) with coronally advanced flap (CAF)	Procedure: CAF+CTG+i-prf; combined connective tissue graft (CTG) and injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF)
Experimental: CAF+CTG+i-prf; the combined connective tissue graft (CTG) and injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF)	Procedure: CAF+CTG+i-prf; combined connective tissue graft (CTG) and injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	six months
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	six months

Collaborators and Investigators

• Sponsor: Cukurova University
• Investigators: Study Director: onur ucak Turer, CukurovaU Prof.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): September 25, 2018
• Study Completion (Actual): March 30, 2019

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: July 23, 2019
• First Posted (Actual): July 25, 2019

Study Record Updates

• Last Update Posted (Actual): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: connective tissue graft
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: CukurovaU-PER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No