Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials

NCT05475795 | Unknown

• 1 other identifier: 576-2022
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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 .

Study Arms (2)

Metapex group

ACTIVE COMPARATOR

Obturation of primary molars with calcium hydroxide and iodoform paste

Other: Metapex; Other: Endoflas

Endoflas group

EXPERIMENTAL

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

Other: Metapex; Other: Endoflas

Interventions

Metapex OTHER

obturation of root canals of primary molars with Metapex

Endoflas group; Metapex group

Endoflas OTHER

obturation of root canals of primary molars with Endoflas

Endoflas group; Metapex group

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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:
• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Nada Mohamed Hassan Saied

Minya, 61511, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Metapex; Endoflas F.S.

Condition Hierarchy (Ancestors)

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

Study Officials

• Osama S Gad El-Hak, PhD

  Pediatric Dentistry Department, Faculty of Dentistry, Minia University

  STUDY DIRECTOR

Central Study Contacts

Osama S Gad El-Hak

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate student at Faculty of Dentistry Minia University

Study Record Dates

• First Submitted: July 24, 2022
• First Posted: July 27, 2022
• Study Start: June 9, 2022
• Primary Completion: December 15, 2022
• Study Completion: January 16, 2023
• Last Updated: August 2, 2022

Record last verified: 2022-07

Locations

EG (1)