Clinical trial NCT03199118: Use of Platelet Rich Fibrin in Addition to CAF and SCTG for Treatment of Gingival Recession
Official title: The Use of Coronally Advanced Flap and Subepithelial Connective Tissue Graft With or Without Platelet Rich Fibrin in the Treatment of Miller Class I or II Gingival Recession: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: root coverage
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Recession Depth
timeFrame: baseline-3 months-6 months
Secondary outcomes:
measure: Recession Width
timeFrame: baseline-3 months-6 months
measure: Root Coverage Gain
timeFrame: at 6 months
measure: Probing Depth
timeFrame: baseline-3 months-6 months
measure: Clinical Attachment Level
timeFrame: baseline-3 months-6 months
measure: Gingival Biotype
timeFrame: baseline-3 months-6 months
measure: Width of Keratinized Gingiva
timeFrame: baseline-3 months-6 months
measure: Patient Satisfaction
timeFrame: questionnaire given to the patient 6 months after the surgery
measure: Root Coverage Esthetic Score (RES)
timeFrame: 6 months
measure: Post Operative Pain
timeFrame: after 2 weeks from surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry
Study officials:
affiliation: Professor of periodontics, Faculty of dentistry, Cairo university
name: Azza Ezzelarab
role: STUDY_DIRECTOR
affiliation: Professor of periodontics, Faculty of dentistry, Cairo university
name: Noha Ghallab
role: STUDY_DIRECTOR
References:
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