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Endodontic Management of Primary Molars

Primary Purpose

Endodontically Treated Teeth

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
OrthoMTA (BioMTA)
Sponsored by
Tokat Gaziosmanpasa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontically Treated Teeth focused on measuring Primary teeth, Root canal filling, Fractal analysis

Eligibility Criteria

8 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tokat Gaziosmanpasa Univercity

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

OrthoMta (BioMTA)

Arm Description

OrthoMTA was applied in primary molars without successors

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
December 25, 2020
Last Updated
December 30, 2020
Sponsor
Tokat Gaziosmanpasa University
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1. Study Identification

Unique Protocol Identification Number
NCT04691050
Brief Title
Endodontic Management of Primary Molars
Official Title
Clinical and Radiologic Evaluation of Root Canal Filling With OrthoMTA in Primary Molars Without Successors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
November 29, 2019 (Actual)
Study Completion Date
June 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth
Keywords
Primary teeth, Root canal filling, Fractal analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OrthoMta (BioMTA)
Arm Type
Other
Arm Description
OrthoMTA was applied in primary molars without successors
Intervention Type
Procedure
Intervention Name(s)
OrthoMTA (BioMTA)
Intervention Description
Primary second molars without successors in which traditional root canal treatment with gutta-percha could not be performed was treated with OrthoMTA
Primary Outcome Measure Information:
Title
Clinical success rate
Description
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.
Time Frame
3 months after root canal treatment
Title
Radiographic success rate
Description
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.
Time Frame
3 months after root canal treatment
Title
Clinical success rate
Description
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.
Time Frame
6 months after root canal treatment
Title
Radiographic success rate
Description
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.
Time Frame
6 months after root canal treatment
Title
Clinical success rate
Description
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.
Time Frame
9 months after root canal treatment
Title
Radiographic success rate
Description
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.
Time Frame
9 months after root canal treatment
Title
Clinical success rate
Description
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.
Time Frame
12 months after root canal treatment
Title
Radiographic success rate
Description
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.
Time Frame
12 months after root canal treatment
Secondary Outcome Measure Information:
Title
Change of fractal dimension
Description
The fractal dimension value of the furcation area between before treatment and 12 months after treatment were compared.
Time Frame
12 months after root canal treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sümeyra Akkoç, Asst Prof
Organizational Affiliation
Kutahya Health Sciences University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tokat Gaziosmanpasa Univercity
City
Tokat
ZIP/Postal Code
60230
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26534871
Citation
Bezgin T, Ozgul BM, Arikan V, Sari S. Root canal filling in primary molars without successors: Mineral trioxide aggregate versus gutta-percha/AH-Plus. Aust Endod J. 2016 Aug;42(2):73-81. doi: 10.1111/aej.12132. Epub 2015 Nov 4.
Results Reference
background
PubMed Identifier
11716086
Citation
O'Sullivan SM, Hartwell GR. Obturation of a retained primary mandibular second molar using mineral trioxide aggregate: a case report. J Endod. 2001 Nov;27(11):703-5. doi: 10.1097/00004770-200111000-00013.
Results Reference
background
PubMed Identifier
20415918
Citation
Tunc ES, Bayrak S. Usage of white mineral trioxide aggregate in a non-vital primary molar with no permanent successor. Aust Dent J. 2010 Mar;55(1):92-5. doi: 10.1111/j.1834-7819.2009.01181.x.
Results Reference
background
PubMed Identifier
28179938
Citation
Asgary S, Fazlyab M. Endodontic Management of an Infected Primary Molar in a Child with Agenesis of the Permanent Premolar. Iran Endod J. 2017 Winter;12(1):119-122. doi: 10.22037/iej.2017.25.
Results Reference
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Endodontic Management of Primary Molars

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