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Effect of Simvastatin as Pulpotomy Agent in Cariously Exposed Permanent Molars

Primary Purpose

Reversible Pulpitis

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Complete Pulpotomy using Mineral Trioxide Aggregate
Complete Pulpotomy using Simvastain -alphatricalcium phosphate
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reversible Pulpitis focused on measuring Permanent teeth, Complete pulpotomy, Simvastatin -alpha tricalcium phosphate, Mineral Trioxide Aggregate

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesAccepts 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.

Sites / Locations

  • PGIDS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Complete Pulpotomy using mineral trioxide aggregate

Complete Pulpotomy using Simvastatin-alphatricalcium phosphate

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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

Full Information

First Posted
April 22, 2020
Last Updated
May 1, 2020
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT04374214
Brief Title
Effect of Simvastatin as Pulpotomy Agent in Cariously Exposed Permanent Molars
Official Title
Effect of Simvastatin on Success of Pulpotomy in Cariously Exposed Permanent Molars: a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reversible Pulpitis
Keywords
Permanent teeth, Complete pulpotomy, Simvastatin -alpha tricalcium phosphate, Mineral Trioxide Aggregate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Complete Pulpotomy using mineral trioxide aggregate
Arm Type
Active Comparator
Arm Description
Twenty-eight patients with curiously exposed permanent molars will be treated with complete pulpotomy by using Mineral Trioxide Aggregate.
Arm Title
Complete Pulpotomy using Simvastatin-alphatricalcium phosphate
Arm Type
Active Comparator
Arm Description
Twenty-eight patients with curiously exposed permanent molars will be treated with complete pulpotomy by using Simvastatin -alphatricalcium phospahte.
Intervention Type
Procedure
Intervention Name(s)
Complete Pulpotomy using Mineral Trioxide Aggregate
Intervention Description
Inflammed coronal pulp tissue will be removed till the canal orifices and mineral trioxide aggregate placed over the amputated pulp stump.
Intervention Type
Procedure
Intervention Name(s)
Complete Pulpotomy using Simvastain -alphatricalcium phosphate
Intervention Description
Inflammed coronal pulp tissue will be removed till the canal orifices and Simvastatin -alpha tricalcium phosphate placed over the amputated pulp stump.
Primary Outcome Measure Information:
Title
Clinical success
Description
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.
Time Frame
Baseline to 12 months
Secondary Outcome Measure Information:
Title
Pain analysis
Description
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
Time Frame
Baseline to 7 days
Title
Radiographic success
Description
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
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudeepender Gehlot
Organizational Affiliation
PGIDS, Rohtak
Official's Role
Principal Investigator
Facility Information:
Facility Name
PGIDS
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India

12. IPD Sharing Statement

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Effect of Simvastatin as Pulpotomy Agent in Cariously Exposed Permanent Molars

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