NCT03328442

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

1.9 years

First QC Date

October 29, 2017

Last Update Submit

January 14, 2018

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction

    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

Study Arms (2)

Vista technique

EXPERIMENTAL

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

modified coronally advanced flap

ACTIVE COMPARATOR

A modified coronally advanced flap utilising Platelet rich fibrin membrane to treat gingival recession defects.

Procedure: modified coronally advanced flap

Interventions

VISTA TechniquePROCEDURE

VISTA with PRF membrane includes Treatment of recession class I and II using autologous PRF membrane

Also known as: Vestibular incision subperiosteal tunnel access
Vista technique
modified coronally advanced flapPROCEDURE

modified coronally advanced flap with PRF membrane for Treatment of recession class I and II

Also known as: MCAF
modified coronally advanced flap

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 22140667BACKGROUND

  • 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.

    PMID: 11022782BACKGROUND

  • 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.

    PMID: 24117676BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Azza Ezzelarab, PhD

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Mohamed S Saleh, Master

CONTACT

01001628350mssaleh213@yahoo.com

Hani M Elnahass, PhD

CONTACT

01000252603Nahass77@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer faculty of dentistry Nahda university

Study Record Dates

First Submitted

October 29, 2017

First Posted

November 1, 2017

Study Start

March 1, 2018

Primary Completion

February 1, 2020

Study Completion

March 1, 2020

Last Updated

January 17, 2018

Record last verified: 2018-01