Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials

Not Applicable

• Conditions: Post Operative Pain
• Interventions: Other: Metapex; Other: Endoflas

• Registration Number: NCT05475795
• Lead Sponsor: Minia University

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2022-06-09
• Status Verified: 2022-07
• Study First Submitted: 2022-07-24
• Study First Submitted QC: 2022-07-24
• Study First Posted: 2022-07-27
• Last Update Submitted: 2022-07-31
• Last Update Posted: 2022-08-02
• Primary Completion: 2022-12-15
• Study Completion: 2023-01-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metapex group	Metapex	Obturation of primary molars with calcium hydroxide and iodoform paste
Metapex group	Endoflas	Obturation of primary molars with calcium hydroxide and iodoform paste
Endoflas group	Metapex	Obturation of primary molars with calcium hydroxide, eugenol and iodoform paste
Endoflas group	Endoflas	Obturation of primary molars with calcium hydroxide, eugenol and iodoform paste

Primary Outcome Measures

Name	Time	Method
postoperative pain.	after one day and after one week .	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).

Trial Locations

Locations (1)

Nada Mohamed Hassan Saied; 🇪🇬 Minya, Egypt