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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04942821
Other study ID # 22-04-2014/418
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Recruiting NCT03037320 - Comparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled Trial N/A
Completed NCT03391947 - Semilunar and Conventional Coronally Positioned Flap for the Treatment Gingival Recession N/A