Endodontically Treated TeethNCT04691050
Endodontic Management of Primary Molars
A study testing OrthoMTA (BioMTA) in people with Endodontically Treated Teeth, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to describe the clinical and radiological outcome of root canal treatment with OrthoMTA in primary second molars without successors in which traditional root canal treatment with gutta-percha could not be performed. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontically Treated Teeth
- What is being tested?
- OrthoMTA (BioMTA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2019to 6 Jun 2020
- 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Selected to be preserved after an orthodontic consultation
- Absence of permanent tooth germ under second primary molars
- Sensitivity to percussion and palpation, complaints of spontaneous or persistent pain
- Presence of irreversible pulpitis or pulp necrosis, and abscess or fistula, presence of pathological mobility,
- Presence of internal and external pathological root resorption
- Furcal lesions
Show all 10Show fewer
- Presence of infection exceeding 1/3 of the root
- Pathological loss of substantial bone support
- Loss of periodontal attachment
- Contraindication of traditional root canal treatment
Who cannot join
- Presence of any systemic disorder
- Presence of any syndrome
- A history or suspicion of allergies
- Age <7 years,
- Teeth selected to be extracted after an orthodontic consultation
- A score of 1(-) or 2(--) according to the Frankl Behavior Scale
- Parents who refused treatment, children who refused to receive the intended treatment once it was initiated
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa Univercity
Tokat Province, 60230
About this study
Official title: Clinical and Radiologic Evaluation of Root Canal Filling With OrthoMTA in Primary Molars Without Successors
The purpose of this study was to describe the clinical and radiological outcome of root canal treatment with OrthoMTA in primary second molars without successors in which traditional root canal treatment with gutta-percha could not be performed.
Read the detailed description
The study included 13 primary mandibular second molars with infected pulp and congenitally missing second premolars in which traditional root canal treatment with gutta-percha was contraindicated. Pulpectomy was performed in each tooth and the canals were filled with OrthoMTA. The clinical and radiological outcomes of the treatment were evaluated at 3, 6, 9, and 12 months. Fractal analysis was used to detect changes in the trabecular bone after the treatment. Repeated measures analysis of variance test and two independent t-tests were used to evaluate the data.
- Conditions
- Endodontically Treated Teeth
- Being tested
- OrthoMTA (BioMTA)
- Keywords
- Primary teeth, Root canal filling, Fractal analysis
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthoMTA (BioMTA)Procedure or surgery
Primary second molars without successors in which traditional root canal treatment with gutta-percha could not be performed was treated with OrthoMTA
| Study group | Role | What they receive |
|---|---|---|
| OrthoMta (BioMTA) | Other | OrthoMTA was applied in primary molars without successors Receives: Procedure: OrthoMTA (BioMTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate
Clinical evaluation of root canal treatment was performed 3 months after treatment using the present clinical criteria. The treatment was decided a clinical success if the tooth fulfilled the following criteria:(1) continued function of the tooth without recurrence of infection; (2) no sensitivity on percussion and palpation; and (3) healthy soft tissues without fistula, abscess, and inflammation of the gums.
Measured: 3 months after root canal treatment
Radiographic success rate
Radiographic evaluation of root canal treatment was performed 3 months after treatment using periapical radiograhps. The treatment was decided to be radiographically successful if it demonstrated the following criteria: (1) decreased radiolucency in the furcation or periradicular region, (2) absence of a new lesion formation.
Measured: 3 months after root canal treatment
Clinical success rate
Clinical evaluation of root canal treatment was performed 6 months after treatment using the present clinical criteria. The treatment was decided a clinical success if the tooth fulfilled the following criteria:(1) continued function of the tooth without recurrence of infection; (2) no sensitivity on percussion and palpation; and (3) healthy soft tissues without fistula, abscess, and inflammation of the gums.
Measured: 6 months after root canal treatment
Radiographic success rate
Radiographic evaluation of root canal treatment was performed 6 months after treatment using periapical radiograhps. The treatment was decided to be radiographically successful if it demonstrated the following criteria: (1) decreased radiolucency in the furcation or periradicular region, (2) absence of a new lesion formation.
Measured: 6 months after root canal treatment
Clinical success rate
Clinical evaluation of root canal treatment was performed 9 months after treatment using the present clinical criteria. The treatment was decided a clinical success if the tooth fulfilled the following criteria:(1) continued function of the tooth without recurrence of infection; (2) no sensitivity on percussion and palpation; and (3) healthy soft tissues without fistula, abscess, and inflammation of the gums.
Measured: 9 months after root canal treatment
Radiographic success rate
Radiographic evaluation of root canal treatment was performed 9 months after treatment using periapical radiograhps. The treatment was decided to be radiographically successful if it demonstrated the following criteria: (1) decreased radiolucency in the furcation or periradicular region, (2) absence of a new lesion formation.
Measured: 9 months after root canal treatment
Clinical success rate
Clinical evaluation of root canal treatment was performed 12 months after treatment using the present clinical criteria. The treatment was decided a clinical success if the tooth fulfilled the following criteria:(1) continued function of the tooth without recurrence of infection; (2) no sensitivity on percussion and palpation; and (3) healthy soft tissues without fistula, abscess, and inflammation of the gums.
Measured: 12 months after root canal treatment
Radiographic success rate
Radiographic evaluation of root canal treatment was performed 12 months after treatment using periapical radiograhps. The treatment was decided to be radiographically successful if it demonstrated the following criteria: (1) decreased radiolucency in the furcation or periradicular region, (2) absence of a new lesion formation.
Measured: 12 months after root canal treatment
Secondary outcomes (1)
Change of fractal dimension
The fractal dimension value of the furcation area between before treatment and 12 months after treatment were compared.
Measured: 12 months after 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 posted31 Dec 2020
- Study start10 May 2019
- Primary completion29 Nov 2019
- Study completion6 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Endodontically Treated TeethStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyra Akkoç, Tokat Gaziosmanpasa University
- Investigators
- Sümeyra Akkoç, Asst Prof, Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691050
- Sponsor's protocol ID
- 19-KAEK-103
- Status last verified
- Dec 2020
- First submitted
- 25 Dec 2020
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bezgin T, Ozgul BM, Arikan V, Sari S. Root canal filling in primary molars without successors: Mineral trioxide aggregate versus gutta-percha/AH-Plus. Aust Endod J. 2016 Aug;42(2):73-81. doi: 10.1111/aej.12132. Epub 2015 Nov 4.
PubMed 26534871O'Sullivan SM, Hartwell GR. Obturation of a retained primary mandibular second molar using mineral trioxide aggregate: a case report. J Endod. 2001 Nov;27(11):703-5. doi: 10.1097/00004770-200111000-00013.
PubMed 11716086Tunc ES, Bayrak S. Usage of white mineral trioxide aggregate in a non-vital primary molar with no permanent successor. Aust Dent J. 2010 Mar;55(1):92-5. doi: 10.1111/j.1834-7819.2009.01181.x.
PubMed 20415918Asgary S, Fazlyab M. Endodontic Management of an Infected Primary Molar in a Child with Agenesis of the Permanent Premolar. Iran Endod J. 2017 Winter;12(1):119-122. doi: 10.22037/iej.2017.25.
PubMed 28179938
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiologic Evaluation of Root Canal Filling With OrthoMTA in Primary Molars Without Successors
- ClinicalTrials.gov ID
- NCT04691050
- Acronym / sponsor ID
- 19-KAEK-103
- Conditions
- Endodontically Treated Teeth
- Keywords
- Primary teeth, Root canal filling, Fractal analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 6 Jun 2020 (actual)
- First posted
- 31 Dec 2020 (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.
The purpose of this study was to describe the clinical and radiological outcome of root canal treatment with OrthoMTA in primary second molars without successors in which traditional root canal treatment with gutta-percha could not be performed.
Detailed description
The study included 13 primary mandibular second molars with infected pulp and congenitally missing second premolars in which traditional root canal treatment with gutta-percha was contraindicated. Pulpectomy was performed in each tooth and the canals were filled with OrthoMTA. The clinical and radiological outcomes of the treatment were evaluated at 3, 6, 9, and 12 months. Fractal analysis was used to detect changes in the trabecular bone after the treatment. Repeated measures analysis of variance test and two independent t-tests were used to evaluate the data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OrthoMta (BioMTA) | Other | Procedure: OrthoMTA (BioMTA)OrthoMTA was applied in primary molars without successors |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Selected to be preserved after an orthodontic consultation
- Absence of permanent tooth germ under second primary molars
- Sensitivity to percussion and palpation, complaints of spontaneous or persistent pain
- Presence of irreversible pulpitis or pulp necrosis, and abscess or fistula, presence of pathological mobility,
- Presence of internal and external pathological root resorption
Key exclusion criteria (7 listed)
- Presence of any systemic disorder
- Presence of any syndrome
- A history or suspicion of allergies
- Age <7 years,
- Teeth selected to be extracted after an orthodontic consultation
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 |
|---|---|---|
| OrthoMTA (BioMTA)Primary second molars without successors in which traditional root canal treatment with gutta-percha could not be performed was treated with OrthoMTA | Procedure or surgery | OrthoMta (BioMTA) |
Primary outcome
Clinical success rate
Time frame: 3 months after root canal treatment
Clinical evaluation of root canal treatment was performed 3 months after treatment using the present clinical criteria. The treatment was decided a clinical success if the tooth fulfilled the following criteria:(1) continued function of the tooth without recurrence of infection; (2) no sensitivity on percussion and palpation; and (3) healthy soft tissues without fistula, abscess, and inflammation of the gums.
Radiographic success rate
Time frame: 3 months after root canal treatment
Radiographic evaluation of root canal treatment was performed 3 months after treatment using periapical radiograhps. The treatment was decided to be radiographically successful if it demonstrated the following criteria: (1) decreased radiolucency in the furcation or periradicular region, (2) absence of a new lesion formation.
Clinical success rate
Time frame: 6 months after root canal treatment
Clinical evaluation of root canal treatment was performed 6 months after treatment using the present clinical criteria. The treatment was decided a clinical success if the tooth fulfilled the following criteria:(1) continued function of the tooth without recurrence of infection; (2) no sensitivity on percussion and palpation; and (3) healthy soft tissues without fistula, abscess, and inflammation of the gums.
Radiographic success rate
Time frame: 6 months after root canal treatment
Radiographic evaluation of root canal treatment was performed 6 months after treatment using periapical radiograhps. The treatment was decided to be radiographically successful if it demonstrated the following criteria: (1) decreased radiolucency in the furcation or periradicular region, (2) absence of a new lesion formation.
Clinical success rate
Time frame: 9 months after root canal treatment
Clinical evaluation of root canal treatment was performed 9 months after treatment using the present clinical criteria. The treatment was decided a clinical success if the tooth fulfilled the following criteria:(1) continued function of the tooth without recurrence of infection; (2) no sensitivity on percussion and palpation; and (3) healthy soft tissues without fistula, abscess, and inflammation of the gums.
Radiographic success rate
Time frame: 9 months after root canal treatment
Radiographic evaluation of root canal treatment was performed 9 months after treatment using periapical radiograhps. The treatment was decided to be radiographically successful if it demonstrated the following criteria: (1) decreased radiolucency in the furcation or periradicular region, (2) absence of a new lesion formation.
Clinical success rate
Time frame: 12 months after root canal treatment
Clinical evaluation of root canal treatment was performed 12 months after treatment using the present clinical criteria. The treatment was decided a clinical success if the tooth fulfilled the following criteria:(1) continued function of the tooth without recurrence of infection; (2) no sensitivity on percussion and palpation; and (3) healthy soft tissues without fistula, abscess, and inflammation of the gums.
Radiographic success rate
Time frame: 12 months after root canal treatment
Radiographic evaluation of root canal treatment was performed 12 months after treatment using periapical radiograhps. The treatment was decided to be radiographically successful if it demonstrated the following criteria: (1) decreased radiolucency in the furcation or periradicular region, (2) absence of a new lesion formation.
1 secondary outcome
Change of fractal dimension
Time frame: 12 months after 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 11 Feb 2026.
- Background: PubMed 26534871Bezgin T, Ozgul BM, Arikan V, Sari S. Root canal filling in primary molars without successors: Mineral trioxide aggregate versus gutta-percha/AH-Plus. Aust Endod J. 2016 Aug;42(2):73-81. doi: 10.1111/aej.12132. Epub 2015 Nov 4.
- Background: PubMed 11716086O'Sullivan SM, Hartwell GR. Obturation of a retained primary mandibular second molar using mineral trioxide aggregate: a case report. J Endod. 2001 Nov;27(11):703-5. doi: 10.1097/00004770-200111000-00013.
- Background: PubMed 20415918Tunc ES, Bayrak S. Usage of white mineral trioxide aggregate in a non-vital primary molar with no permanent successor. Aust Dent J. 2010 Mar;55(1):92-5. doi: 10.1111/j.1834-7819.2009.01181.x.
- Background: PubMed 28179938Asgary S, Fazlyab M. Endodontic Management of an Infected Primary Molar in a Child with Agenesis of the Permanent Premolar. Iran Endod J. 2017 Winter;12(1):119-122. doi: 10.22037/iej.2017.25.
- Individual participant dataSharing planned: No
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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.
Sümeyra Akkoç, Asst Prof principal investigator
Kutahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OrthoMTA (BioMTA) in people with Endodontically Treated Teeth, run by Tokat Gaziosmanpasa University 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 10 inclusion and 7 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 11 Feb 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?
Clinical success rate (time frame: 3 months after root canal treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04691050, which also lists 4 linked publications.
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 11 Feb 2026.