- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03328442
Patient Satisfaction After Root Coverage Using VISTA Technique Compared to MCAF Technique With PRF.
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.
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohamed S Saleh, Master
- Phone Number: 01001628350
- Email: mssaleh213@yahoo.com
Study Contact Backup
- Name: Hani M Elnahass, PhD
- Phone Number: 01000252603
- Email: Nahass77@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
VISTA with PRF membrane includes Treatment of recession class I and II using autologous PRF membrane
Other Names:
|
Active Comparator: modified coronally advanced flap
A modified coronally advanced flap utilising Platelet rich fibrin membrane to treat gingival recession defects.
|
modified coronally advanced flap with PRF membrane for Treatment of recession class I and II
Other Names:
|
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;
|
after 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Azza Ezzelarab, PhD, Cairo University
Publications and helpful links
General Publications
- Zadeh HH. Minimally invasive treatment of maxillary anterior gingival recession defects by vestibular incision subperiosteal tunnel access and platelet-derived growth factor BB. Int J Periodontics Restorative Dent. 2011 Nov-Dec;31(6):653-60.
- Zucchelli G, De Sanctis M. Treatment of multiple recession-type defects in patients with esthetic demands. J Periodontol. 2000 Sep;71(9):1506-14. doi: 10.1902/jop.2000.71.9.1506.
- Zuhr O, Rebele SF, Schneider D, Jung RE, Hurzeler MB. Tunnel technique with connective tissue graft versus coronally advanced flap with enamel matrix derivative for root coverage: a RCT using 3D digital measuring methods. Part I. Clinical and patient-centred outcomes. J Clin Periodontol. 2014 Jun;41(6):582-92. doi: 10.1111/jcpe.12178. Epub 2013 Nov 10.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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