NCT05279781

Outcome of Pulpotomy Versus Root Canal Therapy

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Jordan University of Science and Technology · Academic / Other
• Sex: All
• Age: 9 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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

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: 1. Characteristics of the patient; including age, gender, socioeconomic status, smoking, oral hygiene practices, frequency of dental visits, and dental history. 2. 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. 3. Quality of life instruments designed 4. 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.

Conditions

• Caries
• Pulpitis - Irreversible

Interventions

Type	Name	Description
PROCEDURE	Non surgical root canal treatment	Complete root canal treatment will be performed followed by direct restoration
PROCEDURE	Pulpotomy	Full pulpotomy followed by direct restoration

Timeline

• Start date: 2019-04-01
• Primary completion: 2024-09-20
• Completion: 2025-01-01
• First posted: 2022-03-15
• Last updated: 2022-10-26

Locations

1 site across 1 country: Jordan