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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Egypt
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vestibular Subperiosteal Tunnel Access
Procedure: Vestibular Subperiosteal Tunnel Access vista
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
Procedure: Vestibular Subperiosteal Tunnel Access vista
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Misr International 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19/2017

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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