Outcome of Pulpotomy Versus Root Canal Therapy

Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05279781
• Other study ID #: 375/2019
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: January 2025

Study information

• Verified date: October 2022
• Source: Jordan University of Science and Technology
• Contact: Prof Taha
• Phone: +962776566110
• Email: n.taha[@]just.edu.jo
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2025
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries
• Pulpitis
• Pulpitis - Irreversible

Intervention

Procedure:
• Non surgical root canal treatment
Complete root canal treatment will be performed followed by direct restoration
• Pulpotomy
Full pulpotomy followed by direct restoration

Locations

Country	Name	City	State
Jordan	Jordan University of science and technology	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

References & Publications (1)

Taha NA, About I, Sedgley CM, Messer HH. Conservative Management of Mature Permanent Teeth with Carious Pulp Exposure. J Endod. 2020 Sep;46(9S):S33-S41. doi: 10.1016/j.joen.2020.06.025. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The quality of life questionnaire	A questionnaire validated previously by Dugas et al 2002 will be used to assess Quality of life	6,12, 24, 48 months
Primary	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
Primary	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	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
Secondary	Radiographic success	Periapical x-ray will be taken it should show no bone lesions or root resorption	6, 12, 24, 48 months