NCT06357351

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

1.8 years

First QC Date

April 4, 2024

Last Update Submit

April 9, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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

    baseline, and 6 months

Secondary Outcomes (4)

  • Measuring the probing depth

    baseline, 3 months and 6 months

  • Measuring the plaque index

    baseline, 3 months and 6 months

  • Measuring the gingival index

    baseline, 3 months and 6 months

  • Clinical attachment level

    baseline, 3 months and 6 months

Study Arms (2)

VISTA technique and collagen membrane

EXPERIMENTAL

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.

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).

Procedure: vestibular incision sub periosteal tunnel access ( VISTA) technique.

Interventions

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)

VISTA technique and advanced platelet rich fibrinVISTA technique and collagen membrane

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • (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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university

Al Mansurah, Egypt

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Gingival Recession

Interventions

Methods

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master candidate

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 10, 2024

Study Start

July 1, 2022

Primary Completion

April 1, 2024

Study Completion

May 1, 2024

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations