NCT07467096

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

March 8, 2026

Last Update Submit

March 8, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • change in Gingival recession depth

    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 weeks, 3 months, 6 months

  • change in Gingival recession width (GRW)

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

    2 weeks, 3 months, 6 months

Secondary Outcomes (6)

  • change in Keratinized tissue width (KTW)

    2 weeks, 3 months, 6 months

  • change in Clinical attachment loss (CAL)

    2 weeks, 3 months, 6 months

  • change in Probing depth (PD)

    2 weeks, 3 months, 6 months

  • change in Gingival thickness (GT)

    2 weeks, 3 months, 6 months

  • change in Recession esthetic score (RES)

    2 weeks, 3 months, 6 months

  • +1 more secondary outcomes

Study Arms (2)

Test Group

EXPERIMENTAL
Other: Vestibular incision sub-periosteal tunnel access + fascia lata

Control Group

ACTIVE COMPARATOR
Other: Vestibular incision sub-periosteal tunnel access + subepithelial connective tissue graft

Interventions

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

Test Group

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

Control Group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafr El-sheikh University

Kafr Elsheikh, Egypt

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of Dental Public Health and biostatistical consultanat

Study Record Dates

First Submitted

March 8, 2026

First Posted

March 12, 2026

Study Start

March 1, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations