Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials

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

Detailed Description
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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

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

Conditions
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Post Operative Pain

Intervention / Treatment
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* Other: Metapex
* Other: Endoflas


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3.1. Inclusion criteria: The study will include children who meet the following clinical and radiographic criteria: Clinical: 5-7-year old children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale. Children rated as no.3 or 4 in Frankel behavior rating scale (FBRS). Presence of at least one primary molar with deep carious lesion. Asymptomatic necrotic molars confirmed by the absence of bleeding on opening of the pulp chamber. Radiographic: Extensive caries approaching to the pulp. Presence of at least two-thirds of root length. Exclusion Criteria: A child's tooth with any of the following criteria: Clinical findings: History of spontaneous unprovoked toothache. Extensive crown destruction that preclude coronal restoration. Presence of adjacent or opposing tooth with deep carious lesion in the same side. History of administering analgesics 12 hours before tooth obturation. Radiographic findings: Presence of a large furcation or periapical radiolucency approximating the succedaneous tooth. Presence of pathological internal/external root resorption. Absence of underlying permanent successor.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metapex group<br>Obturation of primary molars with calcium hydroxide and iodoform paste | Other: Metapex<br>* obturation of root canals of primary molars with Metapex<br>Other: Endoflas<br>* obturation of root canals of primary molars with Endoflas<br>|
| Experimental: Endoflas group<br>Obturation of primary molars with calcium hydroxide, eugenol and iodoform paste | Other: Metapex<br>* obturation of root canals of primary molars with Metapex<br>Other: Endoflas<br>* obturation of root canals of primary molars with Endoflas<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 . |