Lesion Sterilization And Tissue Repair Versus Zinc Oxide And Eugenol For Treatment of Necrotic Primary Molars

July 5, 2022 updated by: Esraa Mohamed Ahmed Abdeltawab, Cairo University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Shereen Hassan El shamy, Lecturer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children:

    1. Aged between 5 years and 7 years.
    2. With deep caries involving pulp in primary molars.

  • Teeth:

    1. Necrotic teeth with or without periapical or furcal lesions.
    2. Primary molars with minimal root resorption not more than 1/3 of root.

Exclusion Criteria:

  • Children:

    1. Children with systemic disease
    2. Previous history of allergy to antibiotics used in the study.
    3. Children that will not attend follow up.

  • Teeth:

    1. Caries in primary teeth exhibiting pre-shedding mobility.
    2. Non restorable teeth.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3 MIX
Lesion sterilization and tissue repair; preparation of modified triple antibiotic paste tap: the chemotherapeutic agents used are metronidazole tablets 500 mg (flagyl®, sanofi, egypt), ciprofloxacin tablets 500 mg (ciproxcin®,. Epico, egypt,), and doxycycline capsules 100 mg (doxymycin™ dt, el-nile pharmaceuticals, egypt).
Procedure: Lesion sterilization and tissue repair
Pulp therapy for necrotic primary molars
Active Comparator: Zinc oxide and Eugenol Pulpectomy
zinc oxide and eugenol (prevestdent pro™, egypt).
Procedure: zinc oxide and eugenol pulpectomy
Pulp therapy for necrotic primary molars

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post oper3tive pain
Time Frame: 1 month
Measured by verbal question to patient/parents
1 month
Post operative pain
Time Frame: 3 months
Measured by verbal question to patient/parents
3 months
Post operative pain
Time Frame: 6 months
Measured by verbal question to patient/parents
6 months
Tenderness
Time Frame: 1 month
Percussion test using back of a dental mirror
1 month
Tenderness
Time Frame: 3 months
Percussion test using back of a dental mirror
3 months
Tenderness
Time Frame: 6 months
Percussion test using back of a dental mirror
6 months
Swelling /sinus tract or fistula
Time Frame: 1 month
Visual examination
1 month
Swelling /sinus tract or fistula
Time Frame: 3 months
Visual examination
3 months
Swelling /sinus tract or fistula
Time Frame: 6 months
Visual examination
6 months
Tooth mobility
Time Frame: 1 month
Mobility test
1 month
Tooth mobility
Time Frame: 3 months
Mobility test
3 months
Tooth mobility
Time Frame: 6 months
Mobility test
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Internal /External root resorption
Time Frame: 6 months
Radiographic examination
6 months
Furcation involvement /radiolucency
Time Frame: 6 months
Radiographic examination
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2022

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

June 29, 2022

First Submitted That Met QC Criteria

July 5, 2022

First Posted (Actual)

July 8, 2022

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 5, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSTR 3MIX-MP In Necrotic teeth

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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