Clinical trial

Comparative Evaluation of Success Rate of TheraCal LC Coronal Pulpotomy and MTA Coronal Pulpotomy in Cariously Exposed Mature Permanent Molars- A Randomized Clinical Study

Name

Dr. Vignesh R

Description

To evaluate and compare the clinical and radiographic success rate of TheraCal LC and MTA for coronal pulpotomy of mature permanent molar in 9-14 year children.

Trial arms

Trial start

2022-07-01

Estimated PCD

2024-03-01

Trial end

2024-05-30

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Theracal LC

After hemorrhage control , 1-1.5mm of TheraCal LC will be placed on the radicular pulp stumps followed by light curing, followed by the placement of IRM and composite restorative material after 2 weeks

Arms:

Theracal LC Pulpotomy

Other names:

Resin-modified calcium silicate

MTA

After hemorrhage control , a small ball like consistency of 2-3mm of MTA will be placed on the radicular pulp stumps, followed by the placement of IRM and composite restorative material after 2 weeks

Arms:

MTA Pulpotomy

Other names:

Bioactive calcium silicate

Size

Primary endpoint

Clinical success rate

Baseline to 12 months

Radiographic success rate

Baseline to 12 months

Eligibility criteria

Inclusion Criteria: 1. Patient should be between 9-14 years of age 2. Intermittent or spontaneous, sharp or dull, localized, diffuse, or referred pain 3. Permanent molar tooth with deep caries and subsequent pulp bleeding evident upon excavation of caries. 4. Rapid exposure to dramatic temperature changes elicited heightened and prolonged episodes of pain even after the thermal stimulus has been removed 5. Vital bleeding pulp tissue should be present in all canals after complete pulpotomy 6. Diagnosis should be irreversible pulpitis. 7. The tooth is restorable and free from advanced periodontal disease 8. Soft tissues around the tooth are normal with no swelling or sinus tract 9. Haemostasis should be achieved after complete pulpotomy 10. The patient has non-contributory medical history Exclusion Criteria: 1. Teeth with immature roots 2. Non-restorable 3. Pathological mobility 4. Pus discharge through an associated sinus tract 5. Swelling of associated tissues 6. Radiographic internal or external resorption or with any periapical rarefaction 7. Necrotic pulp upon exposure. 8. Bleeding beyond 25 minutes 9. Children with severe systemic illness (mental retardation/ severe psychotic disorders), prior history of allergy and any medical condition not permitting the intervention. 10. Parents and patients unwilling for participation in the study.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 72, 'type': 'ACTUAL'}}

Updated at

2023-02-17

1 organization

2 products

2 indications

Organization

Postgraduate Institute of Dental Sciences Rohtak

Product

Indication

Indication

Product