Evaluation of increase in hard tissue formation by two different indirect pulp capping agents in primary molars- a randomized controlled trial

Evaluation of the increase in dentinal barrier thickness formed by indirect pulp treatment with two different indirect pulp capping agents in primary molars- a randomized controlled trial - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076988

Enrollment

Registered

2024-11-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: SafeEndo BioStructure MTA putty: composition is Tricalcium Silicate, Dicalcium silicate, Tricalcium Aluminate, Zirconium oxide, Paste forming agents it is an indirect pulp capping agent

Eligibility

Inclusion criteria

Inclusion criteria: Primary molars meeting the following criteria will be included in the study: On clinical examination, large carious lesions involving either occlusal or proximal surfaces, with normal appearances of the gingiva will be identified. Participants with a history of tolerable dull intermittent pain and mild discomfort associated with eating will be included. On radiographic evaluation, primary molars with carious lesions involving more than 2/3rd thickness of dentin approximating the pulp, normal lamina dura and periodontal ligament space, and more than 2/3rd of the root present without periapical changes will be included.

Exclusion criteria

Exclusion criteria: Primary molars with the following criteria will be excluded from the trial: Having history of sharp, penetrating pulpalgia indicating acute pulp inflammation and necrosis, prolonged pain at night. On Clinical examination, presence of mobility of tooth, discoloration of tooth, negative reaction to electric pulp testing, sinus opening or abscessed tooth. On radiographic evaluation, carious lesion with definite pulp exposure, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency, internal or external resorption.

Design outcomes

Primary

Measure	Time frame
To compare the increase in dentinal barrier thickness formed by two types of Indirect pulp capping agents used in the treatment of carious lesions in primary molars over a period of 12 months.Timepoint: 3,6,12 months	—

Secondary

Measure	Time frame
follow upTimepoint: 3,6,12 months	—

Countries

India

Contacts

Public ContactBalagopal Varma R

Amrita School of Dentistry

balagopalvarma@aims.amrita.edu9447032358

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jul 23, 2026