Clinical trial NCT04691050: 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
Overall status: COMPLETED
Phase: NA
Conditions: Endodontically Treated Teeth
Keywords: Primary teeth
Root canal filling
Fractal analysis
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 13
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical success rate
timeFrame: 3 months after root canal treatment
measure: Radiographic success rate
timeFrame: 3 months after root canal treatment
measure: Clinical success rate
timeFrame: 6 months after root canal treatment
measure: Radiographic success rate
timeFrame: 6 months after root canal treatment
measure: Clinical success rate
timeFrame: 9 months after root canal treatment
measure: Radiographic success rate
timeFrame: 9 months after root canal treatment
measure: Clinical success rate
timeFrame: 12 months after root canal treatment
measure: Radiographic success rate
timeFrame: 12 months after root canal treatment
Secondary outcomes:
measure: Change of fractal dimension
timeFrame: 12 months after root canal treatment
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpasa Univercity
Study officials:
affiliation: Kutahya Health Sciences University
name: Sümeyra Akkoç, Asst Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.