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Clinical Trials/NCT04691050
NCT04691050CompletedNot Applicable

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

Tokat Gaziosmanpasa University1 site in 1 country13 target enrollmentStarted: May 10, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
13
Locations
1
Primary Endpoint
Radiographic success rate

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
8 Years to 14 Years (Child)
Sex
All
Accepts 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

Arms & Interventions

OrthoMta (BioMTA)

Other

OrthoMTA was applied in primary molars without successors

Intervention: OrthoMTA (BioMTA) (Procedure)

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • Change of fractal dimension(12 months after root canal treatment)

Investigators

Sponsor
Tokat Gaziosmanpasa University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sümeyra Akkoç

Assistant Proffessor

Tokat Gaziosmanpasa University

Study Sites (1)

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