NCT07064603

Brief Summary

the aim of the study is to evaluate the changes in gingival recession depth reduction following, treatment of multiple RT2 recession with tunnel coronal advanced flap in comparison to coronal advanced flap, both combined with connective tissue graft

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Oct 2025

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Oct 2025Dec 2026

First Submitted

Initial submission to the registry

July 1, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

July 1, 2025

Last Update Submit

July 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Gingival recession depth reduction (GRD)

    ONE YEAR

Secondary Outcomes (9)

  • Percentage of mean root coverage (MRC %)

    one year

  • Percentage of complete root coverage (CRC%)

    one year

  • Gingival Recession width

    one year

  • Keratinized tissue width (KTW)

    one year

  • Probing pocket depth

    one year

  • +4 more secondary outcomes

Study Arms (2)

CORONAL ADVANCED FLAP WITH CONNECTIVE TISSUE GRAFT

ACTIVE COMPARATOR

The surgical papillae will be elevated using split thickness manner while maintaining the blade in a nearly parallel position to the root. * The flap apical to the exposed root will be elevated in a full-thickness The full thickness flap covers the avascular root exposure. * The releasing vertical incisions will be elevated protect the underlying bone in the lateral areas of the flap. * The part of the flap apical to bone exposure will be elevated by split-thickness, this step will be done so it is possible to move the flap passively in the coronal direction. * To permit the coronal advancement of the flap, all muscle insertions present in the thickness of the flap will be eliminated. This will be done by keeping the blade parallel to the external mucosal surface. The connective tissue graft, is harvested from the hard palate (donor site) then it will be sutured in the surgical recipient site then covered by the coronal advancement of the flap and suturing it.

Procedure: TCAF

Tunnel coronal advanced flap with connective tissue graft

EXPERIMENTAL

only one surgical papilla will be elevated. The papilla chosen for incision must be with the least interproximal attachment loss. A slightly divergent vertical incision extending beyond the mucogingival junction then a horizontal incision at a distance equal to the recession depth plus 1 mm apical to the papilla tip. The other papillae integrity is preserved , and will be detached using tunneling miniblades and papilla elevator. The flap will be tunneled till the planned papilla .Connective tissue graft will be harvested the graft will be inserted underneath the flap and tunneled below the non-incised papillae. The TCAF is coronally advanced and stabilized 2 mm above the CEJ with sling and simple interrupted sutures at the level of the papillae and simple interrupted sutures for the vertical incision Further coronal advancement of the tunneled papilla with a suspended suture around the with a composite stop

Procedure: TCAF

Interventions

TCAFPROCEDURE

tunnel coronal advanced flap

CORONAL ADVANCED FLAP WITH CONNECTIVE TISSUE GRAFTTunnel coronal advanced flap with connective tissue graft

Eligibility Criteria

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

You may qualify if:

  • Patients age 18 years or older.
  • Multiple adjacent recession defect classified as RT2.
  • Patients with healthy systemic condition (Mazzotti et al., 2023).
  • An esthetic concern or hypersensitivity associated with GR
  • The gingival recessions must have at least 1.5 mm of KTW.
  • Presence of an identified CEJ (A step ≤ 1mm of the CEJ level)

You may not qualify if:

  • Full-mouth plaque and bleeding scores \>20 (O'Leary et al., 1972)
  • Patients with active periodontal disease;
  • Intake of any medications known to affect gingival homeostasis or to interfere with wound healing
  • Pregnancy and nursing women
  • Smokers: a contraindication for any plastic periodontal surgery (Khuller, 2009).
  • Absence of cervical restorations, crowding or malalignment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

July 1, 2025

First Posted

July 14, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 16, 2025

Record last verified: 2025-07