Caries Clinical Trial - Outcome of Pulpotomy Versus Root Canal Therapy

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05279781
Study type	Interventional
Source	Jordan University of Science and Technology
Contact	Prof Taha
Phone	+962776566110
Email	n.taha@just.edu.jo
Status	Recruiting
Phase	N/A
Start date	April 1, 2019
Completion date	January 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.