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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Necrotic Primary Molars

Intervention / Treatment
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* Procedure: Lesion sterilization and tissue repair
* Procedure: zinc oxide and eugenol pulpectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children: Aged between 5 years and 7 years. With deep caries involving pulp in primary molars. Teeth: 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. Teeth: Caries in primary teeth exhibiting pre-shedding mobility. Non restorable teeth.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 MIX<br>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<br>* Pulp therapy for necrotic primary molars<br>|
| Active Comparator: Zinc oxide and Eugenol Pulpectomy<br>zinc oxide and eugenol (prevestdent pro™, egypt). | Procedure: zinc oxide and eugenol pulpectomy<br>* Pulp therapy for necrotic primary molars<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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