Postoperative Pain After Pulpectomy of Primary Molars

NCT06424353 | Recruiting

• 1 other identifier: 87-577
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

lentilospiral group

EXPERIMENTAL

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

Procedure: Endoflas pulpectomy

pressure seringe group

ACTIVE COMPARATOR

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

Procedure: Endoflas pulpectomy

Interventions

Endoflas pulpectomy PROCEDURE

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

lentilospiral group; pressure seringe group

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The current study will include children who meet the following clinical and radiographic criteria:
• a.Clinical:
• 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.
• b. Radiographic:
• Extensive caries approaching to the pulp.
• Presence of at least two-thirds of root length.

You may not qualify if:

• A child's tooth with any of the following criteria:
• a. 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.
• b. 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Shimaa Mohamed Abd Elhafeez

Minya, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• osama s gad elhak, phD

  Pediatric Dentistry Department, Faculty of Dentistry, Minia University

  STUDY DIRECTOR

Central Study Contacts

shimaa m abd elhafeez, postgraduate

CONTACT

+0201068976757; drshimaaalhhafeez93@gmail.com

Osama s Gad El-Hak, phD

CONTACT

00201023449797; osama.seif@mu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: postgraduate student at faculty of dentistry

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 22, 2024
• Study Start: January 20, 2024
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

EG (1)