Use of Platelet Rich Fibrin in Addition to CAF and SCTG for Treatment of Gingival Recession

Not Applicable

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: CAF +SCTG; Other: platelet rich fibrin

• Registration Number: NCT03199118
• Lead Sponsor: Cairo University

Brief Summary

This research will be conducted in an attempt to achieve complete root coverage with physiologic probing depth and a harmonious view with the adjacent tissues using Platelet rich fibrin in conjunction with Coronally advanced flap and subepithelial connective tissue graft.

Detailed Description

The study population will be divided into 2 groups:

Group 1:

Patients suffering from Miller class I or II gingival recession will be treated with a coronally advanced flap in conjunction with a sub-epithelial connective tissue graft. The patients should be non-smoker, medically free and above 18 years

Group 2:

Patients suffering from Miller class I or II gingival recession will be treated with a coronally advanced flap in conjunction with a sub-epithelial connective tissue graft and platelet rich fibrin. the patients should meet the same inclusion criteria mentionned above.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-21
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-26
• Study Start: 2018-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2021-02
• Results First Submitted: 2021-02-02
• Results First Submitted QC: 2021-02-22
• Last Update Submitted: 2021-02-22
• Results First Posted: 2021-03-22
• Last Update Posted: 2021-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• 1. Patients 18 years and older 2) Buccal recession defects classified as either Miller class I or II gingival recession.

3. Clinical indication and/or patient request for recession coverage 4) Good oral hygiene

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Exclusion Criteria

• 1. Miller Class III and IV gingival recession. 2) Any systemic diseases or any medication. 3) Pregnancy. 4) Patients undergoing radiotherapy. 5) Handicapped and mentally retarded patients. 6) Current and former smokers as smoking is a contra-indication for plastic periodontal surgery .

7. Teeth with cervical restorations, abrasion

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAF+SCTG+PRF	platelet rich fibrin	The patients suffering from class I or II gingival recession in the intervention group will receive a subepithelial connective tissue graft (SCTG) covered by platelet rich fibrin membrane (PRF) followed by a coronally advanced flap (CAF)
CAF+SCTG	CAF +SCTG	Control group patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG only
CAF+SCTG+PRF	CAF +SCTG	The patients suffering from class I or II gingival recession in the intervention group will receive a subepithelial connective tissue graft (SCTG) covered by platelet rich fibrin membrane (PRF) followed by a coronally advanced flap (CAF)

Primary Outcome Measures

Name	Time	Method
Recession Depth	baseline-3 months-6 months	measured from the cemento-enamel junction to the margin of the gingiva at the mid-buccal point of the teeth at basline, 3 months and 6 months. It is recorded in millimeters (mm) with lower values mean better outcome.

Secondary Outcome Measures

Name	Time	Method
Post Operative Pain	after 2 weeks from surgery	Numerical Rating Scale (NRS) with numbers from 0 to 10 ('no pain' to 'worstpain imaginable') for the first 2 weeks postoperatively
Clinical Attachment Level	baseline-3 months-6 months	measured from the CEJ to the base of the sulcus at the midbuccal point of the teeth. Its is recorded in millimeters (mm).
Recession Width	baseline-3 months-6 months	It was measured as the distance from mesial and distal papillae along the CEJ. It is recorded in millimeters (mm) where lower values means a better outcome.
Root Coverage Gain	at 6 months	(preoperative vertical recession - postoperative vertical recession/preoperative vertical recession) x 100.
Probing Depth	baseline-3 months-6 months	measured from the gingival margin to the base of the pocket probe at the midbuccal point of the teeth. Its is recorded in millimeters (mm) where lower values mean better outcome.
Patient Satisfaction	questionnaire given to the patient 6 months after the surgery	printed yes/ no questionnaire with 3 questions: 1. would you do this surgery again?; 2. would you recommend this treatment to others?; 3. are you satisfied with the results?
Gingival Biotype	baseline-3 months-6 months	under local anesthesia from 3 mm below the gingival margin trans-gingivally piercing tissues horizontally, perpendicular to the long axis of the tooth until it contacts bone. Its is recorded in millimeters (mm) where higher values mean better outcome.
Width of Keratinized Gingiva	baseline-3 months-6 months	from the margin of the gingiva to the mucogingival junction at the midbuccal point of the teeth. Its is reported in millimeters where higher values mean better outcome.
Root Coverage Esthetic Score (RES)	6 months	The RES system evaluates 5 variables 6 months after surgery: Zero, 3, or 6 points are used for the evaluation of the position of the gingival margin (GM). A score of 0 or 1 point is used for each of the following variables: marginal tissue contour (MTC), soft tissue texture (STT), mucogingival junction (MGJ) alignment, and gingival color (GC). the points are then summed up to obtain one figure representing the RES.; minimum value:0 maximum value: 10 which means better outcome for RES

Trial Locations

Locations (1)

Faculty of dentistry; 🇪🇬 Cairo, Egypt