Root Canal TherapyNCT07808489
MB2 Canals in Pediatric Maxillary First Molars
A study testing Stepwise MB2 Clinical Confirmation Protocol in people with Root Canal Therapy, run by Sümeyra Akkoç at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Root Canal Therapy
- What is being tested?
- Stepwise MB2 Clinical Confirmation Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kütahya Health Sciences University, Faculty of Dentistry
Kütahya, Kütahya, 43100
About this study
Official title: Clinical Detection of the Second Mesiobuccal Canal in Maxillary Molars of Pediatric Patients
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.
- Conditions
- Root Canal Therapy
- Being tested
- Stepwise MB2 Clinical Confirmation Protocol
- Keywords
- second mesiobuccal canal, permanent maxillary first molar, pediatric dentistry, root canal therapy, microscopy, ultrasonics, cone-beam computed tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepwise MB2 Clinical Confirmation ProtocolDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Stepwise MB2 Clinical Confirmation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Proportion of all treated teeth in which an MB2 canal was clinically confirmed during Stage 1 by direct clinical examination without magnification.
Measured: Periprocedural (immediately after completion of Stage 1 direct clinical examination during root canal treatment)
Incremental Clinical Confirmation Yield Under Dental Loupes
Proportion of all treated teeth in which an MB2 canal was first clinically confirmed during Stage 2 following selective dentin removal under dental loupes at ×4 magnification.
Measured: 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
Proportion of all treated teeth in which an MB2 canal was first clinically confirmed during Stage 3 following selective dentin removal under a dental operating microscope at ×16 magnification.
Measured: 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
Proportion of all treated teeth in which an MB2 canal was first clinically confirmed during Stage 4 following clinically indicated CBCT-guided re-examination.
Measured: Periprocedural (immediately after completion of Stage 4 clinically indicated CBCT-guided re-examination during root canal treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Oct 2023
- Primary completion24 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sümeyra Akkoç
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sümeyra Akkoç, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808489
- Sponsor's protocol ID
- 2023-12/02
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Detection of the Second Mesiobuccal Canal in Maxillary Molars of Pediatric Patients
- ClinicalTrials.gov ID
- NCT07808489
- Acronym / sponsor ID
- 2023-12/02
- Conditions
- Root Canal Therapy
- Keywords
- second mesiobuccal canal, permanent maxillary first molar, pediatric dentistry, root canal therapy, microscopy, ultrasonics, cone-beam computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Sümeyra AkkoçUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stepwise MB2 Clinical Confirmation Protocol | Experimental | Diagnostic Test: Stepwise MB2 Clinical Confirmation ProtocolParticipants 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. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepwise MB2 Clinical Confirmation ProtocolThe 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. | Diagnostic test | Stepwise MB2 Clinical Confirmation Protocol |
Primary outcome
Cumulative Clinical Confirmation Yield of MB2 Canals
Time frame: Periprocedural (at completion of the stepwise MB2 clinical confirmation protocol during root canal treatment)
Proportion of all treated teeth in which an MB2 canal met the predefined clinical confirmation criteria by the end of the stepwise protocol.
4 secondary outcomes
Initial Clinical Confirmation Yield During Direct Clinical Examination
Time frame: Periprocedural (immediately after completion of Stage 1 direct clinical examination during root canal treatment)
Incremental Clinical Confirmation Yield Under Dental Loupes
Time frame: 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
Time frame: 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
Time frame: Periprocedural (immediately after completion of Stage 4 clinically indicated CBCT-guided re-examination during root canal treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepwise MB2 Clinical Confirmation Protocol in people with Root Canal Therapy, run by Sümeyra Akkoç at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Clinical Confirmation Yield of MB2 Canals (time frame: Periprocedural (at completion of the stepwise MB2 clinical confirmation protocol during root canal treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.