Effect of Simvastatin as Pulpotomy Agent in Cariously Exposed Permanent Molars

Effect of Simvastatin on Success of Pulpotomy in Cariously Exposed Permanent Molars: a Randomized Control Trial

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

Study Overview

• Status: Unknown
• Conditions: Reversible Pulpitis
• Intervention / Treatment: Procedure: Complete Pulpotomy using Mineral Trioxide Aggregate; Procedure: Complete Pulpotomy using Simvastain -alphatricalcium phosphate

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • PGIDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 38 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain analysis	Assess the incidence and intensity of pain postoperatively at every 6 hours to 1 day till 7d ays using Visual Analogue scale.Pain intensity will be noted as no pain (0-4mm), mild pain (5-44), moderate pain (45-74mm) and severe pain (75-100mm) on the scale of 0-100mm	Baseline to 7 days
Radiographic success	Radiographic success will be evaluated by change in periapical index (PAI) scores. PAI score 1: Normal periapical structure PAI score 2: Small changes in bone structure PAI score 3: Changes in bone structure with some mineral loss PAI score 4: Periodontis with well defined radiolucent area PAI score 5: Severe periodontitis with elements indicating expansion of lesion	Baseline to 12 months

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: Sudeepender Gehlot, PGIDS, Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Permanent teeth; Complete pulpotomy; Simvastatin -alpha tricalcium phosphate; Mineral Trioxide Aggregate
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis
• Other Study ID Numbers: Dr Sudeepender Gehlot

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No