Esthetic ZoneVISTANCT06723314
Evaluation of Patient Morbidity and Root Coverage Outcomes of VISTA Versus CAF in Treating Gingival Recession
A study testing Vestibular Subperiosteal Tunnel Access vista in people with Esthetic Zone, run by Misr International University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Esthetic Zone
- What is being tested?
- Vestibular Subperiosteal Tunnel Access vista
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2018to 15 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Esthetic Zone
- Being tested
- Vestibular Subperiosteal Tunnel Access vista
- Keywords
- recession , gingival recession, connective tissue graft, coronally advanced flap, patient morbidity
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Subperiosteal Tunnel Access vistaProcedure or surgery
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Subperiosteal Tunnel Access | Experimental | Vestibular Subperiosteal Tunnel Access Receives: Procedure: Vestibular Subperiosteal Tunnel Access vista |
| Coronally Advanced Flap | Active comparator | Coronally Advanced Flap Receives: Procedure: Vestibular Subperiosteal Tunnel Access vista |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Visual Analogue Scale to measure pain from (0-10) with 0 (no pain) and 10 (worst pain)
Measured: 1-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start15 Jan 2018
- Primary completion10 Jan 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esthetic ZoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723314
- Sponsor's protocol ID
- 19/2017
- Acronym
- VISTA
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06723314
- Acronym / sponsor ID
- VISTA / 19/2017
- Conditions
- Esthetic Zone
- Keywords
- recession , gingival recession, connective tissue graft, coronally advanced flap, patient morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular Subperiosteal Tunnel Access | Experimental | Procedure: Vestibular Subperiosteal Tunnel Access vistaVestibular Subperiosteal Tunnel Access |
| Coronally Advanced Flap | Active comparator | Procedure: Vestibular Subperiosteal Tunnel Access vistaCoronally Advanced Flap |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular Subperiosteal Tunnel Access vistaAlso: coronally advanced flapCAF 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. | Procedure or surgery | Coronally Advanced Flap, Vestibular Subperiosteal Tunnel Access |
Primary outcome
Pain Score
Time frame: 1-10 days
Visual Analogue Scale to measure pain from (0-10) with 0 (no pain) and 10 (worst pain)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Subperiosteal Tunnel Access vista in people with Esthetic Zone, run by Misr International University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: 1-10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.