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Clinical Trials/NCT06357351
NCT06357351
Active, not recruiting
Not Applicable

Comparative Evaluation of Vestibular Incision Subperiosteal Tunnel Access With Advanced Platelet-rich Fibrin and Collagen Membrane in the Treatment of Gingival Recession Defects

Mansoura University1 site in 1 country24 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gingival Recession
Sponsor
Mansoura University
Enrollment
24
Locations
1
Primary Endpoint
Measuring the recession width in millimeter
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
May 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marwa Abdelfattah Elkhamisy

Master candidate

Mansoura University

Eligibility Criteria

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 ≤
  • Systemically healthy, willing individuals with good oral hygiene and without contraindications for surgical interventions

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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 Sites (1)

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