Effect of Simvastatin as Pulpotomy Agent in Cariously Exposed Permanent Molars

NCT ID: NCT04374214

Last Updated: 2020-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-06-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Reversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Double

Study Groups

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Complete Pulpotomy using mineral trioxide aggregate

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

Group Type ACTIVE_COMPARATOR

Complete Pulpotomy using Mineral Trioxide Aggregate

Intervention Type PROCEDURE

Inflammed coronal pulp tissue will be removed till the canal orifices and mineral trioxide aggregate placed over the amputated pulp stump.

Complete Pulpotomy using Simvastatin-alphatricalcium phosphate

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

Group Type ACTIVE_COMPARATOR

Complete Pulpotomy using Simvastain -alphatricalcium phosphate

Intervention Type PROCEDURE

Inflammed coronal pulp tissue will be removed till the canal orifices and Simvastatin -alpha tricalcium phosphate placed over the amputated pulp stump.

Interventions

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Complete Pulpotomy using Mineral Trioxide Aggregate

Inflammed coronal pulp tissue will be removed till the canal orifices and mineral trioxide aggregate placed over the amputated pulp stump.

Intervention Type PROCEDURE

Complete Pulpotomy using Simvastain -alphatricalcium phosphate

Inflammed coronal pulp tissue will be removed till the canal orifices and Simvastatin -alpha tricalcium phosphate placed over the amputated pulp stump.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sudeepender Gehlot

Role: PRINCIPAL_INVESTIGATOR

PGIDS, Rohtak

Locations

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PGIDS

Rohtak, Haryana, India

Site Status

Countries

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India

Other Identifiers

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Dr Sudeepender Gehlot

Identifier Type: -

Identifier Source: org_study_id

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