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

Phase 4

• Conditions: Necrotic Primary Molars
• Interventions: Procedure: Lesion sterilization and tissue repair; Procedure: zinc oxide and eugenol pulpectomy

• Registration Number: NCT05448937
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2022-06-29
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-05
• Last Update Submitted: 2022-07-05
• Study First Posted: 2022-07-08
• Last Update Posted: 2022-07-08
• Study Start: 2022-08
• Primary Completion: 2023-08
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 MIX	Lesion sterilization and tissue repair	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).
Zinc oxide and Eugenol Pulpectomy	zinc oxide and eugenol pulpectomy	zinc oxide and eugenol (prevestdent pro™, egypt).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Internal /External root resorption	6 months	Radiographic examination
Furcation involvement /radiolucency	6 months	Radiographic examination