NCT05823415

Brief Summary

The aim of this study is to evaluate reduction of recession depth using lateral closed tunnel technique versus CAF technique using connective tissue graft in single RT2 gingival recession cases.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Status
unknown

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

First Submitted

Initial submission to the registry

February 16, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

11 months

First QC Date

February 16, 2023

Last Update Submit

April 19, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reduction in recession depth

    6 Months

Secondary Outcomes (6)

  • Post-operative pain assessed by VAS Scale

    2 week

  • Probing Depth

    6 months

  • Clinical Attachment Level

    6 months

  • Width of Keratinized Tissue

    6 months

  • Gingival Thickness

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Laterally closed tunnel technique with CTG

EXPERIMENTAL
Procedure: Laterally Closed Tunnel with CTG

Coronally advanced flap with CTG

ACTIVE COMPARATOR
Procedure: CAF with CTG

Interventions

A novel minimally invasive surgical approach laterally closed tunnel technique (LCT) has been recently introduced for the management of isolated gingival recession. The laterally closed tunnel technique ensures predictability by tunneling and mobilization of flap for graft coverage.

Laterally closed tunnel technique with CTG
CAF with CTGPROCEDURE

Gold standard surgical technique

Coronally advanced flap with CTG

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Single RT2 buccal gingival recession ≥ 2 mm in the esthetic zone (Gingival recession associated with loss of inter-proximal attachment. The amount of interproximal attachment loss (measured from the interproximal CEJ to the depth of the interproximal pocket) was less than or equal to the buccal attachment loss (measured from the buccal CEJ to the depth of the buccal pocket)
  • Patients with good oral hygiene
  • Medically free patients
  • No signs of active periodontal disease (with no site showing probing depth \> 4 mm and full-mouth bleeding score (FMBS) 20% (measured at four sites per tooth).
  • Palate with sufficient thickness to accommodate soft tissue defect.

You may not qualify if:

  • Smokers
  • Pregnancy
  • Severe gag reflex
  • Non-carious cervical lesion
  • History of mucogingival or periodontal surgery at the experimental site
  • History of medication that can affect periodontal healing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2023

First Posted

April 21, 2023

Study Start

April 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

April 21, 2023

Record last verified: 2023-04