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Endodontic Management of Primary Molars

Clinical and Radiologic Evaluation of Root Canal Filling With OrthoMTA in Primary Molars Without Successors

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04691050
Enrollment
13
Registered
2020-12-31
Start date
2019-05-10
Completion date
2020-06-06
Last updated
2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endodontically Treated Teeth

Keywords

Primary teeth, Root canal filling, Fractal analysis

Brief 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.

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.

Interventions

PROCEDUREOrthoMTA (BioMTA)

Primary second molars without successors in which traditional root canal treatment with gutta-percha could not be performed was treated with OrthoMTA

Sponsors

Tokat Gaziosmanpasa University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
Yes

Inclusion criteria

* 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 * 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Clinical success rate3 months after root canal treatmentClinical 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 rate3 months after root canal treatmentRadiographic 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.

Secondary

MeasureTime frameDescription
Change of fractal dimension12 months after root canal treatmentThe fractal dimension value of the furcation area between before treatment and 12 months after treatment were compared.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORSümeyra Akkoç, Asst Prof

Kutahya Health Sciences University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026