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NCT Number: NCT07467096

Vestibular Incision Subperiosteal Tunnel Access With Fascia Lata Allograft in The Treatment of Gingival Recession

The present study will be conducted as a randomized controlled clinical study to assess to evaluate the effect of minimally invasive VISTA with fascia lata allograft in the treatment of gingival recession

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafr El-sheikh University

Kafr Elsheikh, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of gingival recession type 1 (RT1) Cairo classification (6)
  • Gingival recession depth ≥ 2 mm.
  • Gingival thickness for the site selected should be ≥1mm.
  • The height of keratinized gingiva (HKG) for the site selected should be ≥2 mm (HKG is the distance between the most apical point of the gingival margin and the mucogingival junction).
  • Optimal compliance as evidenced by no missed treatment appointments and a positive attitude toward oral hygiene.

Exclusion criteria

  • Presence of any systemic disease that could influence the outcome of the therapy.
  • Presence of any risk factor e.g.; smoker, pregnant and lactating patients.
  • Previous history of periodontal surgical treatment in quadrant selected for the study.
  • Restorations or caries in the area to be treated and non-vital tooth.
  • Teeth which are tilted or rotated.
  • Patients taking medications known to cause gingival enlargement.

Treatment and study plan

Vestibular incision sub-periosteal tunnel access + fascia lata

Other

The vestibular incision sub-periosteal tunnel access (VISTA) technique for all groups will be done and the patients will receive VISTA techniques with fascia lata

Vestibular incision sub-periosteal tunnel access + subepithelial connective tissue graft

Other

The vestibular incision sub-periosteal tunnel access (VISTA) technique for all groups will be done and the patients will receive VISTA techniques with subepithelial connective tissue graft CTG

Primary outcomes

  1. change in Gingival recession depth

    Time frame: 2 weeks, 3 months, 6 months

    will be measured at the mid-buccal aspect of the tooth from the (CEJ) to the most apical point of the gingival margin (GM).

  2. change in Gingival recession width (GRW)

    Time frame: 2 weeks, 3 months, 6 months

    it will be measured at the mesiodistal direction of the GM at the level of CEJ

Secondary outcomes

  1. change in Keratinized tissue width (KTW)

    Time frame: 2 weeks, 3 months, 6 months

    will be measured as the distance between the GM and the mucogingival junction (MGJ)

  2. change in Clinical attachment loss (CAL)

    Time frame: 2 weeks, 3 months, 6 months

    will be measured at the mid-buccal aspect of the tooth from CEJ to the bottom of the sulcus.

  3. change in Probing depth (PD)

    Time frame: 2 weeks, 3 months, 6 months

    it will be measured from the GM to the bottom of the sulcus.

  4. change in Gingival thickness (GT)

    Time frame: 2 weeks, 3 months, 6 months

    it will be measured at the mid-buccal aspect of a treated tooth on the long axis, 3 mm apically from the GM using K-file 25 ISO with a silicon marker driven perpendicularly to the gingival surface after application of local anesthesia.

  5. change in Recession esthetic score (RES)

    Time frame: 2 weeks, 3 months, 6 months

    it evaluates five outcome variables (GM level, marginal tissue contour, soft tissue texture, MGJ alignment, and gingival color) leading to a final score ranging from 0 to 10 points.

  6. change in Percentage of root coverage (RC)

    Time frame: 2 weeks, 3 months, 6 months

    it will be calculated at 3 and 6 months post- operative by the following formula: (GRD baseline - GRD 3/6 months)/GRD baseline × 100%

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

Evaluation The Efficacy of Vestibular Incision Subperiosteal Tunnel Access With Fascia Lata Allograft in The Treatment of Gingival Recession A Randomized Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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