Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials

Post Operative Pain Clinical Trial

Official title:

Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials: A Parallel Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05475795
• Other study ID #: 576-2022
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2022
• Est. completion date: January 16, 2023

Study information

• Verified date: July 2022
• Source: Minia University
• Contact: Osama S Gad El-Hak
• Phone: 00201023449797
• Email: osama.seif[@]mu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Testing postopertive pain after pulpectomy of primary molars with Metapex and Endoflas using modified Wong-Baker scale of pain.

Description:

The current equivalent parallel randomized controlled trial will be conducted to evaluate intensity and duration of post-operative pain after pulpectomy of asymptomatic necrotic primary molars, using Metapex and Endoflas obturation materials

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 16, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 7 Years

Eligibility

Inclusion Criteria:

• 3.1. Inclusion criteria: The study will include children who meet the following clinical and radiographic criteria:

Clinical:

1. 5-7-year old children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.

2. Children rated as no.3 or 4 in Frankel behavior rating scale (FBRS).

3. Presence of at least one primary molar with deep carious lesion.

4. Asymptomatic necrotic molars confirmed by the absence of bleeding on opening of the pulp chamber.

Radiographic:

1. Extensive caries approaching to the pulp.

2. Presence of at least two-thirds of root length.

Exclusion Criteria:

• A child's tooth with any of the following criteria:

Clinical findings:

1. History of spontaneous unprovoked toothache.

2. Extensive crown destruction that preclude coronal restoration.

3. Presence of adjacent or opposing tooth with deep carious lesion "in the same side".

4. History of administering analgesics 12 hours before tooth obturation.

Radiographic findings:

1. Presence of a large furcation or periapical radiolucency approximating the succedaneous tooth.

2. Presence of pathological internal/external root resorption.

3. Absence of underlying permanent successor.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Other:
• Metapex
obturation of root canals of primary molars with Metapex
• Endoflas
obturation of root canals of primary molars with Endoflas

Locations

Country	Name	City	State
Egypt	Nada Mohamed Hassan Saied	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain.	Measuring post operative pain after pulpectomy with two different obturation materials using (Modified Wong-backer scale of pain )which have four scales from( 0 to 3) which 0 is the better outcome( no pain) and 3 is the worst (severe pain).	after one day and after one week .