Endodontic Management of Primary Molars

Endodontically Treated Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04691050
• Other study ID #: 19-KAEK-103
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: June 6, 2020

Study information

• Verified date: December 2020
• Source: Tokat Gaziosmanpasa University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 6, 2020
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Endodontically Treated Teeth
• Tooth, Nonvital

Intervention

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

Locations

Country	Name	City	State
Turkey	Tokat Gaziosmanpasa Univercity	Tokat

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months after root canal treatment
Primary	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.	3 months after root canal treatment
Primary	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.	6 months after root canal treatment
Primary	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.	6 months after root canal treatment
Primary	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.	9 months after root canal treatment
Primary	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.	9 months after root canal treatment
Primary	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.	12 months after root canal treatment
Primary	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.	12 months after root canal treatment
Secondary	Change of fractal dimension	The fractal dimension value of the furcation area between before treatment and 12 months after treatment were compared.	12 months after root canal treatment