Postoperative Pain After Pulpectomy of Primary Molars

NCT ID: NCT06424353

Last Updated: 2024-05-22

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

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-20

Study Completion Date

2024-06-30

Brief Summary

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

Detailed Description

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Testing postopertive pain after pulpectomy of primary molars with endoflas using lentilospiral files and pressure seringe by using modified Wong-Baker scale of pain.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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lentilospiral group

Obturation of primary molars with calcium hydroxide, eugenol and iodoform paste using paste carrier files(lentiospiral files)

Group Type EXPERIMENTAL

Endoflas pulpectomy

Intervention Type PROCEDURE

obturation of root canals of primary molars with Endoflas using pressure seringe and lentilospiral files

pressure seringe group

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

Group Type ACTIVE_COMPARATOR

Endoflas pulpectomy

Intervention Type PROCEDURE

obturation of root canals of primary molars with Endoflas using pressure seringe and lentilospiral files

Interventions

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Endoflas pulpectomy

obturation of root canals of primary molars with Endoflas using pressure seringe and lentilospiral files

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* The current study will include children who meet the following clinical and radiographic criteria:

3.1a.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.

3.1b. 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:

3.2a. 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.

3.2b. 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

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Shaimaa Mohamed Abdel Hafeez

postgraduate student at faculty of dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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osama s gad elhak, phD

Role: STUDY_DIRECTOR

Pediatric Dentistry Department, Faculty of Dentistry, Minia University

Locations

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Shimaa Mohamed Abd Elhafeez

Minya, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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shimaa m abd elhafeez, postgraduate

Role: CONTACT

+0201068976757

Osama s Gad El-Hak, phD

Role: CONTACT

00201023449797

Facility Contacts

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shimaa m abd elhafeez, postgraduate

Role: primary

00201068976757

Other Identifiers

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87-577

Identifier Type: -

Identifier Source: org_study_id

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