Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-09

Study Completion Date

2023-01-16

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.

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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

Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Metapex group

Obturation of primary molars with calcium hydroxide and iodoform paste

Group Type ACTIVE_COMPARATOR

Metapex

Intervention Type OTHER

obturation of root canals of primary molars with Metapex

Endoflas

Intervention Type OTHER

obturation of root canals of primary molars with Endoflas

Endoflas group

Obturation of primary molars with calcium hydroxide, eugenol and iodoform paste

Group Type EXPERIMENTAL

Metapex

Intervention Type OTHER

obturation of root canals of primary molars with Metapex

Endoflas

Intervention Type OTHER

obturation of root canals of primary molars with Endoflas

Interventions

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Metapex

obturation of root canals of primary molars with Metapex

Intervention Type OTHER

Endoflas

obturation of root canals of primary molars with Endoflas

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes