Outcome of Pulpotomy Versus Root Canal Therapy

Jordan University of Science and Technology

Status: Enrolling

Conditions: Pulpitis - Irreversible; Caries

Treatments: Procedure: Non surgical root canal treatment; Procedure: Pulpotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05279781

375/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 9 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Root canal treatment group

Active Comparator group

Description:

This group will receive complete root canal therapy

Treatment:

Procedure: Non surgical root canal treatment

Pulpotomy group

Active Comparator group

Description:

This group will receive full pulpotomy

Treatment:

Procedure: Pulpotomy