NCT07526259

Brief Summary

Defects associated with severe interdental hard and soft tissue loss are challenging to the periodontist, mainly due to the increased avascular surface and the reduced interproximal periosteal bed. Reports on the surgical techniques used to address recession type 2 or 3 defects mostly showed statistics on the mid-facial root coverage that yielded outcomes that do not encompass coverage of the interdental exposed root surface which highlights areas of controversy in their use for papilla reconstruction. Several case reports and clinical studies have shown encouraging results, but the long-term data are not available in the literature yet. The novel 3D tunneling (3DT) method achieved significant clinical improvement with long term stability in a recent case series. However, additional research is needed to validate 3DT for its routine clinical use. Moreover, the 3DT method achieved a decrease in the lingual recession depth which should be pointed out that the technique also addresses lingual recession.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress50%
May 2025May 2027

Study Start

First participant enrolled

May 10, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

March 30, 2026

Last Update Submit

April 10, 2026

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

  • Gingival recession depth

    From enrollment to the end of treatment at 1 year

Secondary Outcomes (8)

  • Gingival recession depth lingual

    From enrollment to the end of treatment at 1 year

  • Clinical attachment level (CAL) buccal and lingual

    From enrollment to the end of treatment at 1 year

  • Periodontal probing depth (PPD) buccal and lingual

    From enrollment to the end of treatment at 1 year

  • Width of keratinized tissue (KTW)

    From enrollment to the end of treatment at 1 year

  • Papilla tip to contact point distance

    From enrollment to the end of treatment at 1 year

  • +3 more secondary outcomes

Study Arms (2)

Modified coronally advanced tunnel (MCAT)

ACTIVE COMPARATOR
Procedure: Root coverage

novel 3D tunneling (3DT)

EXPERIMENTAL
Procedure: Root coverage

Interventions

Root coveragePROCEDURE

The novel 3D tunneling (3DT) method achieved significant clinical improvement with long term stability in a recent case series. However, additional research is needed to validate 3DT for its routine clinical use.

Modified coronally advanced tunnel (MCAT)novel 3D tunneling (3DT)

Eligibility Criteria

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

You may qualify if:

  • Buccal and lingual multiple adjacent recession defects classified as Cairo et al RT2.
  • Age ≥18 years
  • Full mouth plaque index score less than 20% O'Leary et al. 1972
  • Patients with healthy systemic condition
  • Clinical indication and/or patient request for root coverage

You may not qualify if:

  • Patients with systemically compromised health
  • Periodontal surgical treatment during the previous 24 months in the involved site
  • Pregnant or lactating mothers
  • Smokers
  • Non-compliant patients
  • Restored teeth
  • Non-carious cervical lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, AlManial, 11562, Egypt

RECRUITING

Related Publications (1)

  • Kazarian E, Inozemtseva K, Lebedeva E. A Novel 3D Tunneling (3DT) Surgical Technique for the Treatment of Gingival Recessions with Reconstruction of the Deficient Interdental Papilla and Interproximal Attachment Regeneration: A Case Series. Int J Periodontics Restorative Dent. 2025 Jan 24;45(1):31-45. doi: 10.11607/prd.6960. PMID: 38198432.

    BACKGROUND

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
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

March 30, 2026

First Posted

April 13, 2026

Study Start

May 10, 2025

Primary Completion (Estimated)

January 10, 2027

Study Completion (Estimated)

May 10, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

EG(1)