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Assessing the efficacy of a novel pulpotomy medicament for treating irreversible pulpitis: A clinical investigation

Evaluating the efficiency of a novel pulpotomy medicament in treating mature permanent teeth with irreversible pulpitis: An in vivo study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/07/089909
Enrollment
30
Registered
2025-07-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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: Simvastatin: Simvastatin in powder form is mixed with distilled water and formed into a thick paste like consistency and placed over the pulp and is covered with MTA. RMGIC is placed ov

Sponsors

RVS DENTAL COLLEGE AND HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients between the age of 16 to 40 years with no medical history. 2. Mature permanent teeth with diagnosis of irreversible pulpitis. 3. Teeth exhibiting positive response to cold and electric pulp test. 4. Restorable teeth with normal probing pocket depth and mobility within normal limits. 5. Pre-operative pain scores less than or equal to 6. 6. Final selection will be made intra operatively, only if there is fresh vital bleeding from the canals and only if hemostasis is achieved within 10 minutes of coronal pulp removal.

Exclusion criteria

Exclusion criteria: 1.Patients under systemic conditions/allergy/medication 2.Previously restored teeth 3.Fractured teeth 4.Non-restorable teeth 5.Teeth with negative response to sensibility test. 6.Teeth with clinical signs and symptoms of pulp necrosis. 7.Teeth exhibiting tenderness on percussion and palpation 8.Presence of swelling or sinus tract or fistula 9.Teeth with pathological mobility Radiographic exclusion including pdl widening, periapical pathology,internal and external resorption,pulp calcification,furcation defects,inter radicular and peri radicular bone destruction Intraoperative exclusion includes no pulp exposure after caries excavation, uncontrollable bleeding of more than 10 minutes and absence of bleeding after pulp exposure.

Design outcomes

Primary

MeasureTime frame
Post-operative pain scores Timepoint: 24 hours, 48 hours, 1 week, 6 months and 12 months

Secondary

MeasureTime frame
Clinical criteria including post operative pain scores, positive response to electric pulp test,no recurrent caries,no tenderness on percussion and palpation,normal mobility limits and probing depth,no abscess or fistula tion, normal surrounding soft tissues Radiographic criteria includes no pdl widening,no new periapical lesion,no resorption or calcification.Timepoint: 6 months and 12 months

Countries

India

Contacts

Public ContactB Suvetha

RVS dental college and hospital, Department of conservative dentistry and endodontics

vinoomds@yahoo.com9841242628

Outcome results

None listed

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