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Clinical and Radiographic Success of Calcium Hydroxide-Iodoform Paste Versus Modified Triple Antibiotic Paste for Necrotic Primary Molars in Children

NCT07773805 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-19

No results posted yet for this study

Summary

This randomized clinical trial aims to compare the clinical and radiographic success of calcium hydroxide-iodoform paste and modified triple antibiotic paste when used for the treatment of necrotic primary molars in children using the lesion sterilization and tissue repair (LSTR) technique. The study will include children aged 4-7 years with restorable necrotic mandibular second primary molars. Participants will be randomly assigned to receive LSTR treatment with either calcium hydroxide-iodoform paste or modified triple antibiotic paste. Clinical and radiographic findings will be assessed during follow-up over 12 months to determine the success of each treatment. The study hypothesis is that there will be a difference in the clinical and radiographic success between the two treatment materials when used with the LSTR technique

Conditions

  • Dental Pulp Necrosis
  • Periapical Diseases
  • Dental Caries
  • Primary Teeth

Interventions

DRUG

Calcium Hydroxide, Iodoform, paste

Calcium hydroxide-iodoform paste will be used as the antimicrobial material for lesion sterilization and tissue repair (LSTR) treatment of necrotic primary molars. Following access to the pulp chamber and the clinical procedures specified in the study protocol, the paste will be placed into the prepared pulp chamber/canal orifices according to the standardized LSTR technique. The tooth will then be restored according to the study protocol. Participants will undergo clinical and radiographic follow-up for 12 months to assess treatment success.

DRUG

modified triple antibiotic paste

Modified triple antibiotic paste will be used as the antimicrobial material for lesion sterilization and tissue repair (LSTR) treatment of necrotic primary molars. The paste will be prepared and applied according to the standardized formulation and clinical protocol specified in the study. Following access to the pulp chamber and the clinical procedures specified in the study protocol, the paste will be placed according to the LSTR technique. The tooth will then be restored according to the study protocol. Participants will undergo clinical and radiographic follow-up for 12 months to assess treatment success.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Prof.Dr.Rania Abdullah Nasr, PhD · Faculty of dentistry , Cairo university , Cairo , Giza , Egypt , 12613

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2028-01-31
Completion
2028-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07773805 on ClinicalTrials.gov