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Endodontic Management of Primary Molars

NCT ID: NCT04691050

Last Updated: 2020-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-10

Study Completion Date

2020-06-06

Brief Summary

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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

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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.

Conditions

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Endodontically Treated Teeth

Keywords

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Primary teeth Root canal filling Fractal analysis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OrthoMta (BioMTA)

OrthoMTA was applied in primary molars without successors

Group Type OTHER

OrthoMTA (BioMTA)

Intervention Type PROCEDURE

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

Interventions

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OrthoMTA (BioMTA)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tokat Gaziosmanpasa University

OTHER

Sponsor Role lead

Responsible Party

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Sümeyra Akkoç

Assistant Proffessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sümeyra Akkoç, Asst Prof

Role: PRINCIPAL_INVESTIGATOR

Kutahya Health Sciences University

Locations

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Tokat Gaziosmanpasa Univercity

Tokat Province, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 26534871 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11716086 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20415918 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28179938 (View on PubMed)

Other Identifiers

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19-KAEK-103

Identifier Type: -

Identifier Source: org_study_id