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Comparative evaluation of clinical and radiographic outcome of 3 indirect pulp capping materials in primary teeth: A Randomized Clinical Trial

Comparative evaluation of clinical and radiographic outcome of MTA, THERACAL LC, and 3MIXTATIN as indirect pulp capping material in primary teeth: A Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101146
Enrollment
60
Registered
2026-01-14
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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: MTA: ProRoot MTA is a biomaterial that has been investigated for endodontic applications since the early 1990s. Despite its many advantages, MTA has some drawbacks such as a long settin

Sponsors

Dr Jaya Bhangdiya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. On clinical examination, deep carious lesion involving occlusal and proximal surfaces or multi surfaces with the gingiva appearing normal in primary second molars. 2. Mild discomfort from chemical and thermal stimuli. 3. History of dull, intermittent, but bearable pain associated with eating. 4. Restorable by a stainless-steel crown (SSC). 5. Radiographically, more than two-thirds of dentin thickness is being involved by caries approaching the pulp with intact lamina dura and periodontal ligament (PDL) space appearing normal. 6. Radiographically more than two-thirds of the root is present, with no periapical changes, and no pathologic external or internal resorption or necrosis. 7. Cooperative children and parents willing to follow the instructions and report for follow-up.

Exclusion criteria

Exclusion criteria: 1. Acute pulpal inflammation and necrosis indicated by a history of sharp penetrating pulpalgia, tenderness on percussion, and prolonged spontaneous pain at night. 2. Clinically, mobile tooth, discolored tooth, and a tooth with sinus opening, fistula, or abscess. 3. Radiographically, interrupted lamina dura, internal or external root resorption, inter radicular or periapical pathoses, and widened periodontal ligament space 4. Presence of chronic systemic diseases such as congenital or rheumatic heart disease, hepatitis, and leukemia 5. On long-term medication such as corticosteroid therapy 6. Physically or mentally challenged.

Design outcomes

Primary

MeasureTime frame
To evaluate and compare the clinical and radiographic outcome of MTA, TheraCal LC and 3Mixtatin as Indirect pulp capping materials in Primary Teeth.Timepoint: BASELINE, 3 MONTH AND 6 MONTH

Secondary

MeasureTime frame
To Compare the clinical and radiographic outcome of MTA, TheraCal LC and 3Mixtatin as Indirect pulp capping materials in Primary Teeth.Timepoint: after 3 month and 6 month

Countries

India

Contacts

Public ContactDR JAYA BHANGDIYA

Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur

milind.wasnik@sdk-dentalcollege.edu.in8888335373

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026