- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06723314
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
Intervention / Treatment
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:
|
|
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:
|
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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