The Evaluation Clinical Results of Coronally Advanced Flap With Platelet Rich Fibrin

Root Coverage Clinical Trial

Official title:

Treatment of Multiple Adjacent Gingival Recessions With Coronally Advanced Flap in Combination With Platelet-Rich Fibrin: A Split-Mouth Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04942821
• Other study ID #: 22-04-2014/418
• Status: Completed
• Phase: N/A
• Start date: April 23, 2014
• Est. completion date: February 24, 2017

Study information

• Verified date: March 2019
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to evaluate the clinical outcomes of platelet- rich fibrin and coronally advanced flap technique in the treatment of multiple gingival recessions in comparison with connective tissue graft technique.

Description:

Aim of this study was to evaluate the clinical outcomes of platelet rich fibrin (PRF)+coronally advanced flap (CAF) technique in the treatment of multiple gingival recessions in comparison with connective tissue graft (CTG)+CAF technique.12 patients with bilateral Miller Class I multiple gingival recessions were treated with PRF+CAF (test group) and CTG+CAF (control group) technique in a split-mouth study design. Probing depth, recession depth (RD), clinical attachment level (CAL), recession width, position of gingival margin, papilla width, keratinized tissue height (KTH), keratinized tissue thickness (KTT) were measured at baseline and 3, 6 and 12 months after surgery. Root coverage (RC) and complete root coverage (CRC) ratios were evaluated post-operatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 24, 2017
• Est. primary completion date: February 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients had at two quadrants, adjacent Miller Class I and at least 2 mm or deeper recessions
• Full mouth plaque score 20% and Full mouth bleeding on probing 10%
• no active periodontal disease,
• involving incisors, canines and premolars,
• age = 18 years

Exclusion Criteria:

• Patients with general diseases which could affect healing process,
• smokers
• Patients had undergone periodontal surgery during the pervious 24 months on the involved sites,
• pregnant or breastfeeding women
• endodontic lesions or non-detectable cemento-enamel junctions at experimental teeth

Related Conditions & MeSH terms

• Gingival Recession
• Root Coverage

Intervention

Procedure:
• Platelet rich fibrin and coronally advanced flap
CAF were used in treatment arms. Root planning was performed on the exposed part of roots to provide more biocompatible surface for re-attachment. Two 10 cc tubes with clot activator were used to collect blood from the patient; blood was centrifuged at 2700 rpm for 12 min. PRF box was used to form fibrin clots into membranes. PRF was positioned at the level of the cemento-enamel junction (CEJ), and sutured on the periosteum bed with 6/0 absorbable sutures. Gingival margins on the flap were placed at least 1 mm coronally of the CEJ and sutured with 5/0 absorbable sutures. Sutures were removed at 2nd week.
• Connective tissue graft and coronally advanced flap
Control sites were treated by coronally advanced flap (CAF) combined with connective tissue graft (CTG). CAF were used in both treatment arms. Root planning was performed on the exposed part of roots to provide more biocompatible surface for re-attachment. CTG was obtained with single incision method. CTG was positioned at the level of the cemento-enamel junction (CEJ), and sutured on the periosteum bed with 6/0 absorbable sutures. Gingival margins on the flap were placed at least 1 mm coronally of the CEJ and sutured with 5/0 absorbable sutures. Sutures were removed at 2nd week.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Root Coverage	The percentage of root coverage was calculated according to the preoperative recession depth to postoperative recession depth.	12 months
Secondary	Complete Root Coverage	Complete root coverage was calculated according to measurement of the pre and post operative gingival margin which was above the enamel-sement junction.	12 months
Secondary	Change from Baseline Keratinized Tissue Width at 3 months	Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction	3 months
Secondary	Change from Baseline Keratinized Tissue Width at 6 months	Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction	6 months
Secondary	Change from Baseline Keratinized Tissue Width at 12 months	Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction	12 months
Secondary	Change from Baseline Gingival Thickness at 3 months	Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.	3 months
Secondary	Change from Baseline Gingival Thickness at 6 months	Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.	6 months
Secondary	Change from Baseline Gingival Thickness at 12 months	Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.	12 months