Endodontic Management of Primary Molars

NCT04691050 | Completed

• 1 other identifier: 19-KAEK-103
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Endodontically Treated Teeth

Keywords

Primary teeth; Root canal filling; Fractal analysis

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Change of fractal dimension

  12 months after root canal treatment

Study Arms (1)

OrthoMta (BioMTA)

OTHER

OrthoMTA was applied in primary molars without successors

Procedure: OrthoMTA (BioMTA)

Interventions

OrthoMTA (BioMTA) PROCEDURE

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

OrthoMta (BioMTA)

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Tokat Gaziosmanpasa Univercity

Tokat Province, 60230, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 26534871 BACKGROUND

• 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.

  PMID: 11716086 BACKGROUND

• 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.

  PMID: 20415918 BACKGROUND

• 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.

  PMID: 28179938 BACKGROUND

MeSH Terms

Conditions

Tooth, Nonvital

Interventions

mineral trioxide aggregate

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Sümeyra Akkoç, Asst Prof

  Kutahya Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffessor

Study Record Dates

• First Submitted: December 25, 2020
• First Posted: December 31, 2020
• Study Start: May 10, 2019
• Primary Completion: November 29, 2019
• Study Completion: June 6, 2020
• Last Updated: February 11, 2026

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)