NCT07239180

Brief Summary

The technique under investigation aims to provide effective root coverage while offering the advantage of being less invasive.

Trial Health

65
Monitor

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
1mo left

Started Dec 2025

Shorter than P25 for not_applicable

Status
not yet 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 Progress91%
Dec 2025Aug 2026

First Submitted

Initial submission to the registry

November 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

December 14, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Expected
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

November 16, 2025

Last Update Submit

November 25, 2025

Conditions

Keywords

Single Recession defects (RT2)TCAFMCATClinical performanceRoot CoverageGingival Recession

Outcome Measures

Primary Outcomes (1)

  • Gingival Recession Depth (GRD)

    Measuring gingival recession depth (GRD) using UNC Periodontal probe in millimeter (mm)

    6 months

Secondary Outcomes (12)

  • The Percentage of Mean Root Coverage (MRC %)

    6 months

  • Complete Root Coverage (CRC)

    6 months

  • Root Coverage Esthetic Score (RES)

    6 months

  • The Distance between the contact point and the top of the papilla (DCP)

    6 months

  • Gingival Recession Width (RW)

    6 months

  • +7 more secondary outcomes

Study Arms (2)

Modified Coronally Advanced Tunnel with Connective Tissue Graft

ACTIVE COMPARATOR
Procedure: Modified Coronally Advanced Tunnel with Connective Tissue Graft

Tunneled Coronally Advance Flap (TCAF) with Connective Tissue Graft

EXPERIMENTAL
Procedure: Tunneled Coronally Advance Flap with Connective Tissue Graft

Interventions

Modified coronally advanced tunnel with connective tissue graft without vertical releasing incisions

Modified Coronally Advanced Tunnel with Connective Tissue Graft

Tunneled coronally advance flap with connective tissue graft with one vertical releasing incision

Tunneled Coronally Advance Flap (TCAF) with Connective Tissue Graft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with single RT2 gingival recession defect ≥ 2 mm
  • Age \>18 years old.
  • Systemically healthy patients with no contraindications for periodontal surgeries.
  • Gingival and plaque index less than 20%.
  • No previous surgeries at the defect site.
  • Accepts 6 months follow-up period (compliant patients).

You may not qualify if:

  • RT1 gingival recession.
  • Smokers \>10 cigarettes a day a contraindicating for any plastic periodontal surgery.
  • Poor oral hygiene.
  • Active periodontitis patients.
  • Patients on medications causing gingival enlargement.
  • Pregnancy.
  • Teeth mobility ≥ 1 mm.
  • Patients using fixed or removable orthodontic appliances.
  • Restoration and/or periapical radiolucency at the defect site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Central Study Contacts

Khaled Hashem Kamal, Masters Degree

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bachelor Degree

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 20, 2025

Study Start

December 14, 2025

Primary Completion

March 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

November 26, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Limited RCTs have been found in the literature comparing the root coverage capacity of the tunneled coronally advanced flap versus modified coronally advanced tunnel combined with connective tissue graft in single RT2 defects. So, this trial aims to fill this gap of knowledge.