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A clinical trial to study the clinical efficacy of two premixed direct pulp capping agents, one available in condensable consistency and other available in injectable consistency on the pulp exposed during caries excavation

One year comparative evaluation of Premixed Bioceramic Putty and Premixed Injectable Bioceramic as a Direct Pulp Capping Material: A Randomized Clinical Study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083573
Enrollment
60
Registered
2025-03-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: Angelus BioC Repair: Premixed Bioceramic available in Putty consistency ready for use of Angelus company and follow up will be done at 15days, 6 months and 1 year. Control Intervention1

Sponsors

Dr Aditi Goel
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy patient aged between 16- 40 years will be included 2. Patients with mechanically and traumatically exposed pulp will be selected 3. Patients having deep carious lesions not involving pulp with clinical diagnosis of reversible pulpitis. 4. Patients showing thin radio-opaque dentin layer between the base of the caries and pulp chamber radiographically. 5. Patients who will give informed consent and are ready to come for follow up will be included.

Exclusion criteria

Exclusion criteria: 1. Teeth with immature roots, those diagnosed with irreversible pulpitis or pulp necrosis, cracks, internal/external root resorption or pulp canal obliteration and exhibiting clinical and/or radiographic signs of chronic/severe periodontitis will be excluded. 2. Patients in which, bleeding will not be controlled after 5 minutes post pulpal exposure after application of 5% sodium hypochlorite. 3. Teeth showing clinically inflamed , bright red or yellowish tissue or dentin chips on the exposure intra-operatively when evaluated under dental microscope will be excluded. 4. Non restorable teeth will be excluded 5. Pregnant or lactating women will be excluded.

Design outcomes

Primary

MeasureTime frame
Absence of pain, pus discharge, tenderness on percussion and palpation, swelling, Maintained vitality of tooth, Healthy PDL status, Continuity of lamina dura, Absence of periapical pathology, and Dentin bridge formationTimepoint: 15 days, 6 months, 12 months

Secondary

MeasureTime frame
Not applicableTimepoint: Not applicable

Countries

India

Contacts

Public ContactDr Aditi Goel

K.M Shah Dental College and Hospital

nshah7873@gmail.com9998994299

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026