Endodontic Management of Primary Molars

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endodontically Treated Teeth

Intervention / Treatment
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* Procedure: OrthoMTA (BioMTA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: OrthoMta (BioMTA)<br>OrthoMTA was applied in primary molars without successors | Procedure: OrthoMTA (BioMTA)<br>* Primary second molars without successors in which traditional root canal treatment with gutta-percha could not be performed was treated with OrthoMTA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 12 months after root canal treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of fractal dimension | The fractal dimension value of the furcation area between before treatment and 12 months after treatment were compared. | 12 months after root canal treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary teeth, Root canal filling, Fractal analysis