Effect of Simvastatin as Pulpotomy Agent in Cariously Exposed Permanent Molars

Reversible Pulpitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04374214
• Other study ID #: Dr Sudeepender Gehlot
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2020
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: June 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis
• Reversible Pulpitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
India	PGIDS	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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