Evaluation of Root Coverage After the Use of Coronally Advanced Flap Either With Advanced Paltelet Rich Fibrin or Subepithilial Connective Tissue Graft in Treatment of Miller Class I and II Gingival Recession.

Not Applicable

• Conditions: Gingival Recession
• Interventions: Procedure: CAF+SCTG; Procedure: CAF + (A-PRF)

• Registration Number: NCT03695549
• Lead Sponsor: Cairo University

Brief Summary

patients with Miller class I , II gingival recession will be divided into 2 groups (control, intervention).the control one will receive coronally advanced flap with subepithililal connective tissue graft harvested from the palate while the intervention one will have coronally advanced flap with advanced platelet rich fibrin(A-PRF).as it represent a new generation of platelet concentrate allow for better healing and root coverage results.

Null hypothesis: In patients with Miller class I and II gingival recession, there is no difference in amount of root coverage (mm) following the application of SCTG+A-PRF compared to CAF+SCTG.

Detailed Description

* Population (P): Patients with single Miller class I, II gingival recessions.

* Intervention (I): Coronally advanced flap (CAF) plus platelet rich fibrin (A-PRF).

* Comparator (C): Coronally advanced flap (CAF) plus subepithelial connective tissue graft (SCTG).

* Primary Outcome (O): Root coverage (mm).

* Time frame: 9 months.

* Study design: Randomized controlled clinical trial.

* Patients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-10
• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-04
• Last Update Submitted: 2018-10-06
• Last Update Posted: 2018-10-09
• Primary Completion: 2019-07
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Systemically healthy patients 18 years old and older both males and females.
• Good oral hygiene after phase I therapy.
• Miller's class I or II gingival recession.
• Not using antibiotics, steroids, chemotherapy or other medications that may modify results of the surgery and healing.
• Cooperative patients able and accept to come for follow up appointments

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Exclusion Criteria

• Pregnant or lactating females.
• Current Smokers.
• Patients with any systemic disease that may affect the periodontal healing.
• Teeth with endodontic treatment, buccal restoration or caries.
• Patients with poor oral hygiene

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	CAF+SCTG	CAF+SCTG
intervention	CAF + (A-PRF)	CAF+ APRF

Primary Outcome Measures

Name	Time	Method
root coverage	9 months	measured in millimeter

Secondary Outcome Measures

Name	Time	Method
Clinical attachment level	9 months	measured in millimeter
Probing depth	9 months	measured in millimeter
Recession width	9 months	measured in millimeter
Gingival esthetics	9 months	Root coverage esthetic score
Width of keratinized gingiva	9 months	measured in millimeter
Gingival thickness	9 months	measured in millimeter
Post-operative pain	measured daily for the first 2 weeks post- operatively.	Visual analog scale (VAS) Questionnaire
Early wound healing	1,2,4 weeks post- surgical	Early wound healing index
Patient Satisfaction	9 months	Post-Surgical Patient Satisfaction Questionnaire