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Status unknownNCT06357351Updated Apr 10, 2024

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

An interventional study of vestibular incision sub periosteal tunnel access ( VISTA) technique. in Gingival Recession, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-10.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Jul 2022, registered Apr 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
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Study 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.

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Conditions studied

  • Gingival Recession

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In context

Gingival Recession

413 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.

This study's enrollment of 24 is below the median of 30 across 379 interventional studies indexed under Gingival Recession.

Browse Gingival Recession studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,114 studies on the registry; 185 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • 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.

  • 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.

Interventions

  • Procedurevestibular 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)

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline, 3 months and 6 months

  2. 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.

    Time frame: baseline, 3 months and 6 months

  3. 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.

    Time frame: baseline, 3 months and 6 months

  4. 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

    Time frame: baseline, and 6 months

Secondary outcomes

  1. 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.

    Time frame: baseline, 3 months and 6 months

  2. 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)

    Time frame: baseline, 3 months and 6 months

  3. 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).

    Time frame: baseline, 3 months and 6 months

  4. 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.

    Time frame: baseline, 3 months and 6 months

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Study locations

1 site
  • Mansoura university
    Al Mansurah, Egypt
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References and documents

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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2022 (actual). Primary completion is estimated for Apr 2024, 21 months after the start.

Of 229 non-industry interventional studies with no phase under Gingival Recession, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's planned 21 months is above that.

Counting every sponsor, half of 231 studies reached it within 19 months; a quarter within 11 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 4, 2024
First posted
Apr 10, 2024
StartActual
Jul 1, 2022
Primary completionEst.
Apr 2024
CompletionEst.
May 2024
Last update
Apr 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06357351
Responsible party
Marwa Abdelfattah Elkhamisy (Master candidate, Mansoura University) — Principal investigator
First posted
Apr 10, 2024
Start date
Jul 1, 2022
Primary completion
Apr 2024 (estimated)
Completion
May 2024 (estimated)
Last update
Apr 10, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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