NCT07808489

Brief Summary

This study examined how often an additional root canal, known as the second mesiobuccal canal (MB2), could be found in the upper first permanent molars of children aged 10-15 years. During root canal treatment, an endodontist followed a step-by-step approach using a standard clinical examination, magnifying loupes, a dental microscope, and, when clinically necessary, three-dimensional dental imaging. The study evaluated how much each step contributed to locating and confirming the canal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

12 months

First QC Date

September 2, 2026

Last Update Submit

September 7, 2026

Conditions

Keywords

second mesiobuccal canalpermanent maxillary first molarpediatric dentistryroot canal therapymicroscopyultrasonicscone-beam computed tomography

Outcome Measures

Primary Outcomes (1)

  • Cumulative Clinical Confirmation Yield of MB2 Canals

    Proportion of all treated teeth in which an MB2 canal met the predefined clinical confirmation criteria by the end of the stepwise protocol.

    Periprocedural (at completion of the stepwise MB2 clinical confirmation protocol during root canal treatment)

Secondary Outcomes (4)

  • Initial Clinical Confirmation Yield During Direct Clinical Examination

    Periprocedural (immediately after completion of Stage 1 direct clinical examination during root canal treatment)

  • Incremental Clinical Confirmation Yield Under Dental Loupes

    Periprocedural (immediately after completion of Stage 2 selective dentin removal under magnifying dental loupes during root canal treatment)

  • Incremental Clinical Confirmation Yield Under a Dental Operating Microscope

    Periprocedural (immediately after completion of Stage 3 selective dentin removal under a dental operating microscope during root canal treatment)

  • Incremental Clinical Confirmation Yield Following CBCT-Guided Re-examination

    Periprocedural (immediately after completion of Stage 4 clinically indicated CBCT-guided re-examination during root canal treatment)

Study Arms (1)

Stepwise MB2 Clinical Confirmation Protocol

EXPERIMENTAL

Participants underwent a predefined stepwise protocol for the clinical confirmation of the second mesiobuccal canal during primary root canal treatment of a permanent maxillary first molar. The protocol progressed from direct clinical examination without magnification to selective dentin removal under dental loupes and then under a dental operating microscope. Clinically indicated CBCT assessment and CBCT-guided re-examination were considered only when clinical confirmation had not been achieved during the first three stages. Once an MB2 canal was clinically confirmed, no subsequent confirmation stage was undertaken.

Diagnostic Test: Stepwise MB2 Clinical Confirmation Protocol

Interventions

The MB2 canal was assessed sequentially using: Stage 1, direct clinical examination without magnification; Stage 2, selective dentin removal under dental loupes at ×4 magnification using ultrasonic instrumentation; Stage 3, selective dentin removal under a dental operating microscope at ×16 magnification; and Stage 4, clinically indicated CBCT assessment followed, when radiographic evidence of an MB2 canal was observed, by CBCT-guided re-examination under the dental operating microscope. Clinical confirmation required identification of an orifice separate from the MB1 canal and negotiation of the canal to the working length.

Stepwise MB2 Clinical Confirmation Protocol

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patients aged 10-15 years requiring primary root canal treatment of a permanent maxillary first molar
  • A clinically and radiographically restorable study tooth
  • "Positive" or "definitely positive" behavior according to the Frankl Behavior Rating Scale
  • No systemic condition contraindicating the planned endodontic treatment
  • No known hypersensitivity to the local anesthetics, irrigation solutions, or other materials used during treatment
  • Written informed consent provided by a parent or legal guardian

You may not qualify if:

  • Previous root canal treatment or endodontic intervention involving the study tooth
  • Presence of a vertical root fracture, root resorption, or pre-existing perforation in the study tooth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kütahya Health Sciences University, Faculty of Dentistry

Kütahya, Kütahya, 43100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Pediatric Dentistry

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 8, 2026

Study Start

October 1, 2023

Primary Completion

September 24, 2024

Study Completion

October 1, 2024

Last Updated

September 8, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Because this is a descriptive study, all data necessary to address the study objectives will be reported in aggregate form in the resulting publication. The underlying individual participant data will not be shared to protect the confidentiality of the pediatric participants

Locations