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Clinical Trials/NCT03695549
NCT03695549
Unknown
Not Applicable

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

Cairo University0 sites20 target enrollmentOctober 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gingival Recession
Sponsor
Cairo University
Enrollment
20
Primary Endpoint
root coverage
Last Updated
7 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 2018
End Date
October 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

heba samir

assistant lecturer

Cairo University

Eligibility Criteria

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

Outcomes

Primary Outcomes

root coverage

Time Frame: 9 months

measured in millimeter

Secondary Outcomes

  • Probing depth(9 months)
  • Clinical attachment level(9 months)
  • Recession width(9 months)
  • Gingival esthetics(9 months)
  • Width of keratinized gingiva(9 months)
  • Gingival thickness(9 months)
  • Post-operative pain(measured daily for the first 2 weeks post- operatively.)
  • Early wound healing(1,2,4 weeks post- surgical)
  • Patient Satisfaction(9 months)

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