Endodontic Management of Primary Molars

Not Applicable

Completed

• Conditions: Endodontically Treated Teeth
• Interventions: Procedure: OrthoMTA (BioMTA)

• Registration Number: NCT04691050
• Lead Sponsor: Tokat Gaziosmanpasa University

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.

Study Timeline

• Study Start: 2019-01-10
• Primary Completion: 2019-11-29
• Study Completion: 2020-06-06
• Status Verified: 2020-12
• Study First Submitted: 2020-12-25
• Study First Submitted QC: 2020-12-30
• Last Update Submitted: 2020-12-30
• Study First Posted: 2020-12-31
• Last Update Posted: 2020-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OrthoMta (BioMTA)	OrthoMTA (BioMTA)	OrthoMTA was applied in primary molars without successors

Primary Outcome Measures

Name	Time	Method
Radiographic success rate	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.
Clinical success rate	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.

Secondary Outcome Measures

Name	Time	Method
Change of fractal dimension	12 months after root canal treatment	The fractal dimension value of the furcation area between before treatment and 12 months after treatment were compared.

Trial Locations

Locations (1)

Tokat Gaziosmanpasa Univercity; 🇹🇷 Tokat, Turkey