Effect of Simvastatin as Pulpotomy Agent in Cariously Exposed Permanent Molars

Postgraduate Institute of Dental Sciences Rohtak

Status: Unknown

Conditions: Reversible Pulpitis

Treatments: Procedure: Complete Pulpotomy using Mineral Trioxide Aggregate; Procedure: Complete Pulpotomy using Simvastain -alphatricalcium phosphate

Study type: Interventional

Funder types: Other

Identifiers

NCT04374214

Dr Sudeepender Gehlot

Details and patient eligibility

About

The study will compare the outcome of complete pulpotomy in mature permanent mandibular molars with deep carious lesions by using Mineral Trioxide Aggregate and Simvastatin -alpha tricalcium phosphate as medicament agent

Full description

After a thorough history, clinical and radiographic examination with all eligibility confirmation, written informed consent will be taken from the patient after explaining the procedure, its associated risks and benefits. Clinical diagnosis of reversible pulpitis will be established. Complete pulpotomy will be done in both groups. Mineral Trioxide Aggregate and Simvastatin -alpha tricalcium phosphate will be used as pulpotomy agents. Pain analysis will be carried out preoperatively and postoperatively at every 6 hours for 1 day and then every 24 hours till 7 days after the intervention. All the subjects will be followed up for evaluation of clinical and radiographic success at 3, 6 months and 1 year.

Enrollment: 56 estimated patients

Sex: All

Ages: 15 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patient willing to participate in the study.
2. Age group of 15 to 40 years
3. Mature permanent mandibular molars with reversible pulpitis (positive response on the cold test and early response as compared to the adjacent or contralateral tooth)
4. Teeth exhibiting occlusal pulp exposure from primary dental caries.
5. Absence of periapical lesions assessed by radiographic examination.
6. Tooth demonstrating no mobility or swelling and no tenderness to percussion or palpation

Exclusion criteria

1. Primary teeth.
2. Teeth with irreversible pulpitis (spontaneous pain) or pulp necrosis, chronic periodontitis, cracked tooth, internal or external resorption, calcified canals, associated with sinus tract and furcation or apical radiolucency.
3. Immune-compromised, pregnant and patients with any systemic disorder.
4. Patients taking statin medication.
5. Failure to obtain authorization from the patient.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

Complete Pulpotomy using mineral trioxide aggregate

Active Comparator group

Description:

Twenty-eight patients with curiously exposed permanent molars will be treated with complete pulpotomy by using Mineral Trioxide Aggregate.

Treatment:

Procedure: Complete Pulpotomy using Mineral Trioxide Aggregate

Complete Pulpotomy using Simvastatin-alphatricalcium phosphate

Active Comparator group

Description:

Twenty-eight patients with curiously exposed permanent molars will be treated with complete pulpotomy by using Simvastatin -alphatricalcium phospahte.

Treatment:

Procedure: Complete Pulpotomy using Simvastain -alphatricalcium phosphate