Gingival RecessionNCT06357351
Comparison of Using Collagen Membrane and A-PRF Using VISTA Technique in Gingival Recession Treatment
A study testing vestibular incision sub periosteal tunnel access ( VISTA) technique. in people with Gingival Recession, run by Mansoura University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- vestibular incision sub periosteal tunnel access ( VISTA) technique.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to May 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- (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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Gingival Recession
- Being tested
- vestibular incision sub periosteal tunnel access ( VISTA) technique.
- 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 incision sub periosteal tunnel access ( VISTA) technique.Procedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| VISTA technique and collagen membrane | Experimental | Participants undergo periodontal surgery using the vestibular incision sub-periosteal tunnel access technique (VISTA) and collagen membrane. Receives: Procedure: vestibular incision sub periosteal tunnel access ( VISTA) technique. |
| VISTA technique and advanced platelet rich fibrin | Experimental | Participants undergo periodontal surgery using the vestibular incision sub-periosteal tunnel access technique (VISTA) and advanced platelet-rich fibrin (A-PRF). Receives: Procedure: vestibular incision sub periosteal tunnel access ( VISTA) technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the recession width in millimeter
self-report assessment by using the UNC-15 Periodontal Probe, measured at the level of Cemento-Enamel Junction CEJ.
Measured: baseline, 3 months and 6 months
Measuring the recession depth in millimeter
self-report assessment by using the UNC-15 Periodontal Probe, measured from the cemento-enamel junction CEJ to the free gingival junction.
Measured: baseline, 3 months and 6 months
Measuring the width of keratinized gingiva in millimeter
self-report assessment by using the UNC-15 Periodontal Probe. measured from the free gingiva margin to the mucogingival junction.
Measured: baseline, 3 months and 6 months
Mean of root coverage
was measured by the following formula:. Mean root coverage formula: (pre-operative recession depth - post-operative recession depth)/(pre-operative recession depth ) ×100
Measured: baseline, and 6 months
Secondary outcomes (4)
Measuring the probing depth
self-report assessment by using the UNC-15 Periodontal Probe. Measured from the free gingival margin to the base of the sulcus.
Measured: baseline, 3 months and 6 months
Measuring the plaque index
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)
Measured: baseline, 3 months and 6 months
Measuring the gingival index
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).
Measured: baseline, 3 months and 6 months
Clinical attachment level
self-report assessment by using the UNC-15 Periodontal Probe, measured from the cemento-enamel junction to the base of the pocket.
Measured: baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Jul 2022
- Primary completionApr 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies 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
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Abdelfattah Elkhamisy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357351
- Sponsor's protocol ID
- VISTA in gingival recession
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdelhaleem M, Saleh W, Elmeadawy S. Treatment of gingival recession with vestibular incision subperiosteal tunnel access and advanced platelet-rich fibrin. BMC Oral Health. 2025 Jan 14;25(1):63. doi: 10.1186/s12903-024-05398-w.
PubMed 39806320
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Vestibular Incision Subperiosteal Tunnel Access With Advanced Platelet-rich Fibrin and Collagen Membrane in the Treatment of Gingival Recession Defects
- ClinicalTrials.gov ID
- NCT06357351
- Acronym / sponsor ID
- VISTA in gingival recession
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 10 Apr 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VISTA technique and collagen membrane | Experimental | Procedure: vestibular incision sub periosteal tunnel access ( VISTA) technique.Participants undergo periodontal surgery using the vestibular incision sub-periosteal tunnel access technique (VISTA) and collagen membrane. |
| VISTA technique and advanced platelet rich fibrin | Experimental | Procedure: vestibular incision sub periosteal tunnel access ( VISTA) technique.Participants undergo periodontal surgery using the vestibular incision sub-periosteal tunnel access technique (VISTA) and advanced platelet-rich fibrin (A-PRF). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- (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
Key exclusion criteria (6 listed)
- 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.
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 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) | Procedure or surgery | VISTA technique and advanced platelet rich fibrin, VISTA technique and collagen membrane |
Primary outcome
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.
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.
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.
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
4 secondary outcomes
Measuring the probing depth
Time frame: baseline, 3 months and 6 months
Measuring the plaque index
Time frame: baseline, 3 months and 6 months
Measuring the gingival index
Time frame: baseline, 3 months and 6 months
Clinical attachment level
Time frame: baseline, 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 39806320Abdelhaleem M, Saleh W, Elmeadawy S. Treatment of gingival recession with vestibular incision subperiosteal tunnel access and advanced platelet-rich fibrin. BMC Oral Health. 2025 Jan 14;25(1):63. doi: 10.1186/s12903-024-05398-w.
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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 incision sub periosteal tunnel access ( VISTA) technique. in people with Gingival Recession, run by Mansoura 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Apr 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?
Results are not available in the source record.
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?
Measuring the recession width in millimeter (time frame: baseline, 3 months and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06357351, which also lists 1 linked publication.
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 10 Apr 2024.