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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sudeepender Gehlot | PGIDS, Rohtak | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PGIDS | Rohtak | Haryana | 124001 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41652862 | Derived | Gehlot S, Kumar V, Mittal S, Duhan J, Sangwan P, Arora M, Chauhan N. Effect of Simvastatin on Success of Pulpotomy in Carious Permanent Molars With Symptomatic Irreversible Pulpitis: A Randomised Controlled Trial. Aust Endod J. 2026 Feb 6. doi: 10.1111/aej.70062. Online ahead of print. |
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Double
| 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. |
|
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 |