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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06424353
Other study ID # 87-577
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 20, 2024
Est. completion date June 2024

Study information

Verified date May 2024
Source Minia University
Contact shimaa m abd elhafeez, postgraduate
Phone +0201068976757
Email drshimaaalhhafeez93@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 5 Years to 7 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Shimaa Mohamed Abd Elhafeez 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 techniques 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
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