Outcome of Pulpotomy Versus Root Canal Therapy

Study Overview
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Brief Summary
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Root canal therapy (RCT) is indicated once the pulp is diagnosed with irreversible pulpitis. Despite favorable success rate reported for RCT in vital cases, it is time consuming, and might increases fracture susceptibility of teeth. With the advancement of materials and better understanding of pulpal healing, vital pulp therapy is practiced as an alternative treatment with high success rate. The aim of this study is to explore the outcome, quality of life and patient satisfaction after full pulpotomy compared to RCT.

Detailed Description
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Permanent molar teeth with carious pulp exposure and mature roots as evident on the preoperative periapical radiograph will be included in the study. The teeth will be randomly divided into 2 groups (n=30). The first group will be treated with Biodentine full pulpotomy and the second group will be endodontically treated. Based on a previously validated questionnaire. The quality of life and satisfaction of patients after pulpotomy treatment will be evaluated compared to those after endodontic treatment. Clinical and radiographic assessment of the treated teeth will be done 3, 6 and 12 months postoperatively. Pain level will be recorded preoperatively and 1, 2, 3, 5 and 7 days after treatment. The questionnaire consists of five components: Characteristics of the patient; including age, gender, socioeconomic status, smoking, oral hygiene practices, frequency of dental visits, and dental history. Postoperative complications including postoperative pain, discomfort,or swelling. These symptoms will be evaluated after 1, 2, 3,5 and 7 days by contacting the patient on the phone and at follow up visits at 3, 6, and 12 months. Quality of life instruments designed Semantic scales designed to evaluate patient satisfaction with the treatment received. Clinical and radiographic assessment of the treated teeth will be recorded. Success will be defined as clinically asymptomatic tooth with no sinus tract or swelling or periapical lesion. Data will be analysed statistically using appropriate tests based on the distribution of the results.

Official Title
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Quality of Life, Satisfaction and Outcome After Full Pulpotomy Compared to Root Canal Therapy

Conditions
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Caries, Pulpitis - Irreversible

Intervention / Treatment
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* Procedure: Non surgical root canal treatment
* Procedure: Pulpotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medically fit patient mature permanent tooth with deep caries diagnosis of irreversible pulpits. tooth is restored with a direct restoration Exclusion Criteria: immature teeth teeth were hemostasis cannot be achieved after pulpotomy necrotic teeth lack of response to cold test

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 70 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
Interventional Model Description: Two groups. One will receive root canal treatment t and the other will receive pulpotomy.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Root canal treatment group<br>This group will receive complete root canal therapy | Procedure: Non surgical root canal treatment<br>* Complete root canal treatment will be performed followed by direct restoration<br>|
| Active Comparator: Pulpotomy group<br>This group will receive full pulpotomy | Procedure: Pulpotomy<br>* Full pulpotomy followed by direct restoration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain level on numerical pain scale | Pain level after treatment will be assessed on a numerical scale from 0-10 where is zero refer to no pain and 10 is the most sever pain. | 7 days | 
| Post operative pain level on visual analogue scale | Pain level after treatment will be assessed on a visual analogy scale from 0-10, where is zero refer to no pain and 10 is the most sever pain. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success | The tooth should be pain free, no sinus tract, no tenderness to palpation and no swelling. As measured by clinical examination | 6, 12, 24, 48 months | 
| Radiographic success | Periapical x-ray will be taken it should show no bone lesions or root resorption | 6, 12, 24, 48 months |