Effect of Simvastatin as Pulpotomy Agent in Cariously Exposed Permanent Molars

NCT04374214 | Unknown DMC

• 1 other identifier: Dr Sudeepender Gehlot
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Reversible Pulpitis

Keywords

Permanent teeth; Complete pulpotomy; Simvastatin -alpha tricalcium phosphate; Mineral Trioxide Aggregate

Outcome Measures

Primary Outcomes (1)

• Clinical success

  criteria for successful clinical outcome will be absence of clinical sign and symtoms which include Absence of tenderness to percussion,tooth mobility of grade 1 or less.Absence of associated soft tissue swelling or tenderness to palpation.

  Baseline to 12 months

Secondary Outcomes (2)

• Pain analysis

  Baseline to 7 days

• Radiographic success

  Baseline to 12 months

Study Arms (2)

Complete Pulpotomy using mineral trioxide aggregate

ACTIVE COMPARATOR

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

Procedure: Complete Pulpotomy using Mineral Trioxide Aggregate

Complete Pulpotomy using Simvastatin-alphatricalcium phosphate

ACTIVE COMPARATOR

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

Procedure: Complete Pulpotomy using Simvastain -alphatricalcium phosphate

Interventions

Complete Pulpotomy using Mineral Trioxide Aggregate 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 mineral trioxide aggregate

Complete Pulpotomy using Simvastain -alphatricalcium phosphate PROCEDURE

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

Complete Pulpotomy using Simvastatin-alphatricalcium phosphate

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Primary teeth.
• 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.
• Immune-compromised, pregnant and patients with any systemic disorder.
• Patients taking statin medication.
• Failure to obtain authorization from the patient.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

Location

Study Officials

• Sudeepender Gehlot

  PGIDS, Rohtak

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: May 5, 2020
• Study Start: December 1, 2018
• Primary Completion: April 30, 2020
• Study Completion: June 30, 2020
• Last Updated: May 5, 2020

Record last verified: 2020-04

Locations

IN (1)