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OpenTrials
Completed

NCT Number: NCT04691050

Endodontic Management of Primary Molars

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.

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Key information

Conditions

Endodontically Treated Teeth Dental Pulp Diseases Stomatognathic Diseases Tooth Diseases Tooth, Nonvital

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tokat Gaziosmanpasa Univercity

Tokat Province, 60230, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OrthoMTA (BioMTA)

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. Change of fractal dimension

    Time frame: 12 months after root canal treatment

    The fractal dimension value of the furcation area between before treatment and 12 months after treatment were compared.

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Dec 31, 2020
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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