Patient Satisfaction After Root Coverage Using VISTA Technique Compared to MCAF Technique With PRF.

January 14, 2018 updated by: Mohamed Salah salaheldin, Cairo University

Evaluation of Patient Satisfaction After Root Coverage Procedure Using VISTA Technique Compared to Modified Coronally Advanced Flap Technique in Conjunction With Platelet Rich Fibrin-membrane.

VISTA technique with PRF compared to MCAF technique with PRF to treat gingival recession

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Comparison between two techniques for root coverage divided in two groups the first (test group) VISTA technique in conjunction with PRF-membrane and the second (control group)MCAF technique in conjunction with PRF-membrane for treating Miller's class I and II gingival recession defects.

Clinical Periodontal Records will be taken at baseline, 3 months and 6 months respectively.

Visual analogue scale for pain during one week after operation. Patient satisfaction record using questionnaire after 6 months.

Study Type

Interventional

Enrollment (Anticipated)

16

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 to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Age (18-55) Miller's classI and II multiple GR width of KG>2 mm

Exclusion Criteria:

  • Systemic diseases Poor oral hygiene Smoking Patient allergy Miller's class III and IV

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vista technique
The vista technique with PRF membrane uses a Vestibular incision subperiosteal tunnel access in combination with Platelet rich fibrin membrane to treat gingival recession defects.
Procedure: VISTA Technique
VISTA with PRF membrane includes Treatment of recession class I and II using autologous PRF membrane
Other Names:
  • Vestibular incision subperiosteal tunnel access
Active Comparator: modified coronally advanced flap
A modified coronally advanced flap utilising Platelet rich fibrin membrane to treat gingival recession defects.
Procedure: modified coronally advanced flap
modified coronally advanced flap with PRF membrane for Treatment of recession class I and II
Other Names:
  • MCAF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: after 6 months

Using a questionnaire which are designed in a dichotomous fashion (yes or no ) and calculated by percentage of answering yes.

it not a scale, the following questions will be asked to the patients;

  1. did you feel pain in spite of the medication prescribed?
  2. did you perceive the course of healing unexpected restriction?
  3. did you experience any remaining symptoms of parasethesia?
  4. would you described the under taken effort as reasonable?
  5. have your expectations been fulfilled?
after 6 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Azza Ezzelarab, PhD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2018

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

October 29, 2017

First Submitted That Met QC Criteria

October 29, 2017

First Posted (Actual)

November 1, 2017

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 14, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2017-10-30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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