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Status unknownNCT06424353Updated May 22, 2024

Postoperative Pain After Pulpectomy of Primary Molars

An interventional study of Endoflas pulpectomy in Postoperative Pain, sponsored by Minia University. Status unknown at 1 site in Egypt. Open to participants aged 5 Years to 7 Years. Per ClinicalTrials.gov, last updated 2024-05-22.

Sponsored by Minia University · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified May 2024), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jan 2024, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
5 Years to 7 Years
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Postoperative Pain

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03

In context

Pain, Postoperative

5,227 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.

This study's planned enrollment of 100 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Minia University is the lead sponsor of 369 studies on the registry; 117 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    lentilospiral group

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

    Procedure: Endoflas pulpectomy

  • Active comparator
    pressure seringe group

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

    Procedure: Endoflas pulpectomy

Interventions

  • ProcedureEndoflas pulpectomy

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

06

What researchers measure

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)

    Time frame: after one day and after one week

07

Study locations

1 of 1 sites recruiting
  • Shimaa Mohamed Abd Elhafeez
    Minya, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06424353
Lead sponsor
Minia University
Responsible party
Shaimaa Mohamed Abdel Hafeez (postgraduate student at faculty of dentistry, Minia University) — Principal investigator
First posted
May 22, 2024
Start date
Jan 20, 2024
Primary completion
May 2024 (estimated)
Completion
Jun 2024 (estimated)
Last update
May 22, 2024

Study contacts

shimaa m abd elhafeez, postgraduate
Contact
drshimaaalhhafeez93@gmail.com
+0201068976757
Osama s Gad El-Hak, phD
Contact
osama.seif@mu.edu.eg
00201023449797
osama s gad elhak, phD
study director · Pediatric Dentistry Department, Faculty of Dentistry, Minia University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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