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Clinical Trials/NCT05448937
NCT05448937
Completed
Phase 2

Clinical And Radiographic Evaluation Of Lesion Sterilization And Tissue Repair Versus Zinc Oxide And Eugenol For Treatment of Necrotic Primary Molars

Cairo University1 site in 1 country60 target enrollmentOctober 1, 2022

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Necrotic Primary Molars
Sponsor
Cairo University
Enrollment
60
Locations
1
Primary Endpoint
Post oper3tive pain
Status
Completed
Last Updated
9 months ago

Overview

Brief Summary

The aim of this study is to evaluate the clinical and radiographic success of Lesion Sterilization And Tissue Repair [ LSTR] antibiotic paste versus Zinc Oxide and Eugenol pulpectomy in the treatment of non-vital primary molars.

Detailed Description

Primary teeth with infected root canals are a common problem, particularly in patients where the infection has reached the peri radicular tissues . Among the pastes used in the pulp therapy of primary teeth with pulp necrosis, zinc oxide and eugenol paste has been a reference in dentistry since 1930. Endodontic treatment using zinc oxide and eugenol paste has shown satisfactory clinical and radiographic results, requires mechanical chemical preparation before filling root canals. The main difficulties of endodontic treatment of primary molars are related to the anatomical complexity of the root canals and the long time needed to carry out the treatment. The additional difficulty involved in diagnosing root resorption is a limiting condition for determining the actual working length and instrumentation. Other pastes have been studied, such as those containing antibiotics in their composition, thus dispensing with root canal instrumentation (such as lesion sterilization and tissue repair using triple antibiotic paste in treatment of non-vital primary molars. Lesion sterilization and tissue repair using triple antibiotic paste has relevant clinical and radiographic success rates in treatment of non-vital primary molars.

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
March 8, 2025
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Esraa Mohamed Ahmed Abdeltawab

principlal investigator

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Children:
  • Aged between 5 years and 7 years.
  • With deep caries involving pulp in primary molars.
  • Necrotic teeth with or without periapical or furcal lesions.
  • Primary molars with minimal root resorption not more than 1/3 of root.

Exclusion Criteria

  • Children:
  • Children with systemic disease
  • Previous history of allergy to antibiotics used in the study.
  • Children that will not attend follow up.
  • Caries in primary teeth exhibiting pre-shedding mobility.
  • Non restorable teeth.

Outcomes

Primary Outcomes

Post oper3tive pain

Time Frame: 1 month

Measured by verbal question to patient/parents

Tenderness

Time Frame: 6 months

Percussion test using back of a dental mirror

Post operative pain

Time Frame: 6 months

Measured by verbal question to patient/parents

Swelling /sinus tract or fistula

Time Frame: 6 months

Visual examination

Tooth mobility

Time Frame: 6 months

Mobility test

Secondary Outcomes

  • Furcation involvement /radiolucency(6 months)
  • Internal /External root resorption(6 months)

Study Sites (1)

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