Endodontic Management of Primary Molars

Sponsor
Tokat Gaziosmanpasa University (Other)
Overall Status
Completed
CT.gov ID
NCT04691050
Collaborator
(none)
13
1
1
16.9
0.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: OrthoMTA (BioMTA)
N/A

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
Actual Enrollment :
13 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical and Radiologic Evaluation of Root Canal Filling With OrthoMTA in Primary Molars Without Successors
Actual Study Start Date :
Jan 10, 2019
Actual Primary Completion Date :
Nov 29, 2019
Actual Study Completion Date :
Jun 6, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: OrthoMta (BioMTA)

OrthoMTA was applied in primary molars without successors

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

Outcome Measures

Primary Outcome Measures

  1. Clinical success rate [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 [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 [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 [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 [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 [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 [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 [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 Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 14 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tokat Gaziosmanpasa Univercity Tokat Turkey 60230

Sponsors and Collaborators

  • Tokat Gaziosmanpasa University

Investigators

  • Principal Investigator: Sümeyra Akkoç, Asst Prof, Kutahya Health Sciences University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sümeyra Akkoç, Assistant Proffessor, Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier:
NCT04691050
Other Study ID Numbers:
  • 19-KAEK-103
First Posted:
Dec 31, 2020
Last Update Posted:
Dec 31, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sümeyra Akkoç, Assistant Proffessor, Tokat Gaziosmanpasa University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 31, 2020