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Clinical Trials/NCT06256250
NCT06256250
Active, not recruiting
Not Applicable

The Effect of Different Instrumentation Techniques on the Post-Operative Pain in Pulpectomy Treatment of Primary Molars: A Blind Randomized Controlled Clinical Trial

Mansoura University1 site in 1 country75 target enrollmentAugust 10, 2023
ConditionsPulp Necroses

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulp Necroses
Sponsor
Mansoura University
Enrollment
75
Locations
1
Primary Endpoint
Assessment of post-operative pain after pulpectomy treatment in primary teeth
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

The goal of this clinical trial is to compare the post operative pain after using three different instrumentation techniques in pulpectomy treatment of pediatric participant. The main question it aims to answer:

If different instrumentation techniques will affect the post operative pain in pulpectomy treatment of primary molars ? Participants will evaluate the pain using Modified Wong baker pain rating scale.

Researchers will compare [ the adaptive XP endo shaper, Fanta AF baby files, and hand K files] to see if they will affect the post operative pain.

Registry
clinicaltrials.gov
Start Date
August 10, 2023
End Date
May 11, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amal Taha

Principal Investigator

Mansoura University

Eligibility Criteria

Inclusion Criteria

  • Cooperative children free from systemic diseases.
  • Teeth with sufficient coronal tooth structure.
  • Teeth with necrotic pulp.
  • Teeth should have 2/3 of the remaining roots.

Exclusion Criteria

  • Children taking medications up to six hours before the treatment.
  • Children with multiple teeth that required pulpectomy will not be included to eliminate the possibility of pain referral.
  • Excessive tooth mobility.
  • Teeth with perforated pulpal floor.
  • Teeth with external or internal root resorption.

Outcomes

Primary Outcomes

Assessment of post-operative pain after pulpectomy treatment in primary teeth

Time Frame: one week

Assessment of post-operative pain using Modified Wong-baker pain rating scale. It is 4-point scale measures pain as: * Score zero - no pain. * Score one - slight pain. * Score two - moderate pain. Score three - severe pain. so ( score 0 is the best score \& score 3 is the worst) These data will be recorded at intervals of 6, 12, 24, 72 hours, and one week. A telephonic communication will be done with the parents by the second assessor who will be blinded to the treatment protocol at 6, 12, 72 hours to assess the pain, and the patients will be given two appointments, first after 24 hours and the second after one week from the operating day. During both visits, the second assessor will collect the results of the pain assessment from the child's parent and will cross-check all the results to ensure that the reported values are consistent.

Study Sites (1)

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