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.

Sponsor:

Collaborators:

Information provided by (Responsible Party):

heba samir，Cairo University

Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

July 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

root coverage[ Time Frame: 9 months ]

measured in millimeter

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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.

Official Title ^ICMJE

Root Coverage After the Use of Coronally Advanced Flap With Advanced Platelet Rich Fibrin (A- PRF) Compared With Subepithelial Connective Tissue Graft in Management of Miller Class I and II Gingival Recession. A Randomized Clinical Trial

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 Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Procedure: CAF + (A-PRF)
advanced platelet rich fibrin prepared by low speed centrfugation concept(LSCC) together with coronally advanced flap .
Procedure: CAF+SCTG
cornally advanced flap plus subepithilial connective tissue graft harvested from the palate

Study Arms

Active Comparator: intervention
CAF+ APRF
Active Comparator: control
CAF+SCTG

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 2019

Estimated Primary Completion Date

July 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 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

Sex/Gender

Sexes Eligible for Study:

All

Ages

15 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

heba samir，Cairo University

Study Sponsor ^ICMJE

Cairo University

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair: manal M hosny, professor faculty of Dentistry-Cairo University
Study Director: engi A mahmoud, assistant professor faculty of Dentistry-Cairo University

PRS Account

Cairo University

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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