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.

October 6, 2018 updated by: heba samir, Cairo University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intervention
CAF+ APRF
Procedure: CAF + (A-PRF)
advanced platelet rich fibrin prepared by low speed centrfugation concept(LSCC) together with coronally advanced flap .
Active Comparator: control
CAF+SCTG
Procedure: CAF+SCTG
cornally advanced flap plus subepithilial connective tissue graft harvested from the palate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
root coverage
Time Frame: 9 months
measured in millimeter
9 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Heba Samir Mhmoud, assistant lecturer, Cairo University
  • Study Director: Manal M Hosny, Professor, Cairo University
  • Study Chair: Engi A Mahmoud, assistant professor, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

October 1, 2018

First Submitted That Met QC Criteria

October 2, 2018

First Posted (Actual)

October 4, 2018

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 6, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • assistant lecturer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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