Assessment of Pain and Treatment Success After VPT Versus RCT in Mature Permanent Mandibular Molars With SIP: A RCT

Study Overview
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Brief Summary
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Assessment of postoperative pain and treatment success after vital pulp therapy versus root canal treatment in mandibular molar with signs and symptoms of irreversible pulpitis. the null hypothesis, there is no difference will be observed in the pain level and treatment success between two treatments.

Detailed Description
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After proper clinical and radiographic examination. Teeth will be anesthetized and isolated using a rubber dam. The operative field will be disinfected. Total caries removal will be done from outside making margin caries free to inside. the new diamond bur will be used to remove the last layer and exposed the pulp tissue. Exposed pulp will be inspected under a dental operating microscope and hemostasis will be obtained. The teeth will be randomized into 2 intervention groups (VPT or RCT). Treatment will be finalized, and teeth will be restored with resin-modified glass ionomer followed by composite resin at the same appointment. Ibuprofen 400mg will be prescribed to the patient if needed. Patients will be asked to record postoperative pain after treatment on the pain score sheet.

Official Title
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Assessment of Postoperative Pain and Treatment Success After Vital Pulp Therapy Versus Root Canal Treatment in Mature Permanent Mandibular Molars With Irreversible Pulpitis: A Randomized Controlled Trial

Conditions
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Symptomatic Irreversible Pulpitis

Intervention / Treatment
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* Procedure: Root canal treatment
* Procedure: Vital pulp therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy patients. Patient's age range more than 15 years. Mature permanent mandibular molars with deep caries. Clinical diagnosis of symptomatic irreversible pulpitis. Teeth with no need for the post. Healthy periodontium and mobility within normal limits. Patients who can understand the pain scale and can sign the informed consent Exclusion Criteria: Teeth with a negative response to vitality testing. Teeth with furcal bone loss. Teeth with sinus tract Teeth with swelling. Teeth with a non-restorable crown. Teeth with immature roots. Teeth with no pulp exposure even after caries excavation. History of analgesic intake in the previous week. History of antibiotic intake in the previous month. Insufficient bleeding after pulp exposure suggestive of partial necrosis of the pulp. Inability to control bleeding within 10 min. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Root canal treatment<br>after access cavity preparation, the working length will be determined. chemo-mechanical preparation will be done, and teeth will be obturated. final restoration will be placed. | Procedure: Root canal treatment<br>* after access cavity preparation, the working length will be determined. chemo-mechanical preparation will be done, and teeth will be obturated. final restoration will be placed.<br>* Other names: RCT, Full pulpectomy;|
| Experimental: Vital pulp therapy<br>exposed pulp will be capped with 3 mm calcium silicate material | Procedure: Vital pulp therapy<br>* exposed pulp will be capped with 3 mm calcium silicate material<br>* Other names: pulpotomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | postoperative pain will be recorded by patient using NRS | at 6 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of postoperative pain | postoperative pain will be recorded by patient using NRS | at 24, 48 hours and 7 days | 
| Treatment success | clinical and radiographic success | at 3,6,12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SIP