Evaluation of Patient Morbidity and Root Coverage Outcomes of VISTA Versus CAF in Treating Gingival Recession (VISTA)

December 7, 2024 updated by: Misr International University

Evaluation of Patient Morbidity and Root Coverage Outcomes of Vestibular Incision Sub Periosteal Tunnel Access Versus Coronally Advanced Flap in Treating Gingival Recession in Esthetic Zone, Randomized Clinical Trial

To evaluate and compare Vestibular Incision Subperiosteal Tunnel Access (VISTA) technique,with connective tissue graft; versus Coronally Advanced Flap (CAF) technique;with connective tissue graft, in treating gingival recession in esthetic zone. Patients and Methods: Thirty patients, with Miller class I or class II gingival recession, were included in the current study, with age range from 18 to 55 years. Defects were treated using either VISTA combined with connective tissue graft technique, or CAF combined with connective tissue technique. Post-operative discomfort was evaluated using the Visual Analog Scale (VAS) to assess patient morbidity. At baseline, 3, 6 and 9 months, clinical parameters were assessed; Probing Depth (PD), Clinical Attachment Level (CAL), Gingival recession Height (GH), Keratinized Tissue Height (KTH), while Complete and Mean Root Coverage (CRC, MRC) were recorded after nine months. Results: The present study revealed that VISTA showed higher significant difference in pain.VISTA also showed a more reduction in PD, CAL, GH as well as KTH than that of CAF with no significant difference between either of the groups.

Study Overview

Status

Completed

Conditions

Detailed Description

To evaluate and compare Vestibular Incision Subperiosteal Tunnel Access (VISTA) technique,with connective tissue graft; versus Coronally Advanced Flap (CAF) technique;with connective tissue graft, in treating gingival recession in esthetic zone. Patients and Methods: Thirty patients, with Miller class I or class II gingival recession, were included in the current study, with age range from 18 to 55 years. Defects were treated using either VISTA combined with connective tissue graft technique, or CAF combined with connective tissue technique. Post-operative discomfort was evaluated using the Visual Analog Scale (VAS) to assess patient morbidity. At baseline, 3, 6 and 9 months, clinical parameters were assessed; Probing Depth (PD), Clinical Attachment Level (CAL), Gingival recession Height (GH), Keratinized Tissue Height (KTH), while Complete and Mean Root Coverage (CRC, MRC) were recorded after nine months. Results: The present study revealed that VISTA showed higher significant difference in pain.VISTA also showed a more reduction in PD, CAL, GH as well as KTH than that of CAF with no significant difference between either of the groups. Conclusions: Based on the results of the current study, it can be concluded that both techniques allow improvement in root coverage with no significant differences between them, while VISTA technique showed more pain scores by the VAS than that of CAF technique.

Study Type

Interventional

Enrollment (Actual)

30

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.

Study Locations

      • Cairo, Egypt, 4651010
        • Misr International Unversity

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age between 18- 55 years
  • No sexual discrepancy
  • Medically free
  • Good oral hygeine
  • Sound teeth with single (measuring ≥ 2 mm) or Multiple (measuring ≥ 1 mm)
  • Class I or II gingival recession defects and adequate amount of keratinized tissue (3mm width).

Exclusion Criteria:

  • Patients on anticoagulants, antiplatelets, or glucocorticoids.
  • Pregnant females or lactating female patients
  • Smoking patients.
  • Patients with parafunctional habits.
  • Tooth extraction in the surgical sites, active periodontal disease or history of previous surgery in the same area.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vestibular Subperiosteal Tunnel Access
CAF procedures were performed (Split-Full-Split flap), following the anesthetic agent, the sulcular incision was performed by a full thickness vertical incision till the muccogingival junction• Split thickness releasing incision was made at the flap base with full thickness flap reflection till the muccogingival junction.
Other Names:
  • coronally advanced flap
Active Comparator: Coronally Advanced Flap
CAF procedures were performed (Split-Full-Split flap), following the anesthetic agent, the sulcular incision was performed by a full thickness vertical incision till the muccogingival junction• Split thickness releasing incision was made at the flap base with full thickness flap reflection till the muccogingival junction.
Other Names:
  • coronally advanced flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: 1-10 days
Visual Analogue Scale to measure pain from (0-10) with 0 (no pain) and 10 (worst pain)
1-10 days

Collaborators and Investigators

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

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 (Actual)

January 15, 2018

Primary Completion (Actual)

January 10, 2020

Study Completion (Actual)

October 15, 2020

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 7, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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