Comparison of Using Collagen Membrane and A-PRF Using VISTA Technique in Gingival Recession Treatment

April 9, 2024 updated by: Marwa Abdelfattah Elkhamisy, Mansoura University

Comparative Evaluation of Vestibular Incision Subperiosteal Tunnel Access With Advanced Platelet-rich Fibrin and Collagen Membrane in the Treatment of Gingival Recession Defects

To assess the efficacy of minimally invasive Vestibular Incision Subperiosteal Tunnel Access (VISTA) with collagen membrane and Advanced Platelet-rich Fibrin (A-PRF) in the treatment of multiple buccal gingival recession type 1(RT1) Cairo Classification.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.

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.
24

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
      • Mansoura, Egypt
        • Mansoura University

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:

  • (18-50) years old with at least 2 sites with gingival recession type (RT1) Cairo Classification (GR with no interdental attachment loss). The interdental CEJ is not detectable clinically on the labial surfaces of the teeth.
  • Recession in the maxillary anterior region ≥1 mm of attached gingiva, pocket depth (PD) of <3 mm, recession depth (RD) ≥2 mm, and gingival index (GI) score ≤1.
  • Systemically healthy, willing individuals with good oral hygiene and without contraindications for surgical interventions

Exclusion Criteria:

  • the presence of severe systematic diseases or immunodeficiency and contraindicated with surgical interventions.
  • Allergies to medicaments used in the treatment process.
  • Patients with removable or fixed dentures.
  • Patients with cervical abrasion, direct and indirect restorations involving the cervical areas of the maxillary anterior.
  • Participants with smoking, tobacco chewing, and alcohol consumption.
  • The presence of high frenal attachment and participants who had previously undergone any periodontal surgical procedure or regenerative therapy in the past 1 year at the same site of the planned treatment.

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: VISTA technique and collagen membrane
Participants undergo periodontal surgery using the vestibular incision sub-periosteal tunnel access technique (VISTA) and collagen membrane.
Procedure: vestibular incision sub periosteal tunnel access ( VISTA) technique.
In comparison between the two groups, the first group uses collagen membrane and the other group uses advanced PRF using the same surgical technique (VISTA)
Experimental: VISTA technique and advanced platelet rich fibrin
Participants undergo periodontal surgery using the vestibular incision sub-periosteal tunnel access technique (VISTA) and advanced platelet-rich fibrin (A-PRF).
Procedure: vestibular incision sub periosteal tunnel access ( VISTA) technique.
In comparison between the two groups, the first group uses collagen membrane and the other group uses advanced PRF using the same surgical technique (VISTA)

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
Measuring the recession width in millimeter
Time Frame: baseline, 3 months and 6 months
self-report assessment by using the UNC-15 Periodontal Probe, measured at the level of Cemento-Enamel Junction CEJ.
baseline, 3 months and 6 months
Measuring the recession depth in millimeter
Time Frame: baseline, 3 months and 6 months
self-report assessment by using the UNC-15 Periodontal Probe, measured from the cemento-enamel junction CEJ to the free gingival junction.
baseline, 3 months and 6 months
Measuring the width of keratinized gingiva in millimeter
Time Frame: baseline, 3 months and 6 months
self-report assessment by using the UNC-15 Periodontal Probe. measured from the free gingiva margin to the mucogingival junction.
baseline, 3 months and 6 months
Mean of root coverage
Time Frame: baseline, and 6 months
was measured by the following formula:. Mean root coverage formula: (pre-operative recession depth - post-operative recession depth)/(pre-operative recession depth ) ×100
baseline, and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measuring the probing depth
Time Frame: baseline, 3 months and 6 months
self-report assessment by using the UNC-15 Periodontal Probe. Measured from the free gingival margin to the base of the sulcus.
baseline, 3 months and 6 months
Measuring the plaque index
Time Frame: baseline, 3 months and 6 months
According to Silness and Leo, this index determines the thickness of the plaque along the gingival margin. possible score range from 0 (no plaque) to 1 ( thin plaque located at gingival margin only detected by periodontal probe), 2 ( moderate plaque thickness detected by naked eye located at gingival margin), and 3 ( abundant plaque thickness at gingival margin and interproximal area)
baseline, 3 months and 6 months
Measuring the gingival index
Time Frame: baseline, 3 months and 6 months
According to Silness and Leo, this index determines the description of the gingiva of examined teeth. possible score range from 0 (normal gingiva) to 1 (mild inflammation; slight erythema; no bleeding.) / 2 (moderate inflammation; erythema and bleeding on probing) or 3 (severe inflammation; severe erythema, swelling, and spontaneous bleeding).
baseline, 3 months and 6 months
Clinical attachment level
Time Frame: baseline, 3 months and 6 months
self-report assessment by using the UNC-15 Periodontal Probe, measured from the cemento-enamel junction to the base of the pocket.
baseline, 3 months and 6 months

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.
Mansoura 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.
July 1, 2022

Primary Completion (Estimated)

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.
April 1, 2024

Study Completion (Estimated)

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.
May 1, 2024

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).
April 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.
April 9, 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.
April 10, 2024

Study Record Updates

Last Update Posted (Actual)

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.
April 10, 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.
April 9, 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.
April 1, 2024

More Information

Terms related to this study

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.
  • VISTA in gingival recession

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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