Clinical Success of Indirect Pulp Capping: 1-Year Follow-Up

NCT06325540 | Completed

• 1 other identifier: pulpcapping
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the clinical success of theracal pt, therabase, and biodentine indirect pulp capping on primary molars with deep dentin caries. Indirect pulp capping was used on the primary molars of the participants with deep dentin caries. It is aimed to compare the success of biodentine, which is considered the gold standard used in capping treatments, and the currently marketed Teracal PT and Therabase materials after 1, 6 months and 1 year, with biodentine and with each other, and find out which material is more successful.

Conditions

Dentin, Carious; Indirect Pulp Capping

Keywords

calcium silicate; deep dentine carries; indirect pulp capping

Outcome Measures

Primary Outcomes (2)

• successful completion of research

  Completion of 1-year follow-up of patients. The patients were called for follow-up at 1 months, 6 months and 1 year during the first year. At each follow-up visit, a clinical examination was performed to assess the presence of tenderness to percussion or palpation, spontaneous pain or prolonged pain response, discoloration, infectious symptoms such as fistula or abscess, and pathological mobility. Additionally, a radiographic examination was performed to assess the presence of lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The teeth detected with none of these findings at any time considered successful.

  1 year

• unseccessful completion of research

  The patients were called for follow-up at 1 months, 6 months and 1 year during the first year. At each follow-up visit, a clinical examination was performed to assess the presence of tenderness to percussion or palpation, spontaneous pain or prolonged pain response, discoloration, infectious symptoms such as fistula or abscess, and pathological mobility. Additionally, a radiographic examination was performed to assess the presence of lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The teeth detected with at least one of these findings were considered 'unsuccessful.'

  1 year

Study Arms (3)

theracal pt

EXPERIMENTAL

Teeth treated with indirect pulp capping with theracal pt

Procedure: indirect pulp capping with theracal pt

therabase

EXPERIMENTAL

Teeth treated with indirect pulp capping with therabase

Procedure: indirect pulp capping with therabase

biodentine

ACTIVE COMPARATOR

Teeth treated with indirect pulp capping with biodentine

Procedure: indirect pulp capping with biodentine

Interventions

indirect pulp capping with theracal pt PROCEDURE

indirect pulp capping using the theracal pt material

theracal pt

indirect pulp capping with therabase PROCEDURE

indirect pulp capping using the therabase material

therabase

indirect pulp capping with biodentine PROCEDURE

indirect pulp capping using the biodentine material

biodentine

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children aged 5-9 years
• Previously untreated first and second primary molars with deep caries
• First and second primary molar teeth with positive pulpal response in vitality tests
• Primary molar teeth with radiographically detected caries involving approximately ¾ of the dentin thickness
• Primary molar teeth with the potential for pulp exposure according to the procedure in which the carious tissue is completely removed

You may not qualify if:

• Teeth showing signs of irreversible pulpitis (spontaneous pain, no prolonged pain response)
• Teeth with symptoms of pain on percussion or palpation
• Teeth with pathological mobility
• Teeth with infectious symptoms such as fistula or abscess
• Teeth showing discoloration on clinical examination
• Radiolucency observed in the periapical region or furcation on radiographic examination

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Sağlık Bilimleri Üniversitesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Interventions

tricalcium silicate

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• şükriye türkoğlu kayacı

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: patients and the researcher who evaluates the follow-up results of the patients will not know which material was used for indirect pulp coating.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Indirect pulp capping will be applied to primary molar teeth with deep dentin caries in 3 groups with 3 different materials(biodentine, thermal pt, therabase).

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 22, 2024
• Study Start: January 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 15, 2024
• Last Updated: July 25, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)