Lesion Sterilization And Tissue Repair Versus Zinc Oxide And Eugenol For Treatment of Necrotic Primary Molars
Primary Purpose
Necrotic Primary Molars
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Lesion sterilization and tissue repair
zinc oxide and eugenol pulpectomy
Sponsored by
About this trial
This is an interventional treatment trial for Necrotic Primary Molars
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
3 MIX
Zinc oxide and Eugenol Pulpectomy
Arm Description
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 (prevestdent pro™, egypt).
Outcomes
Primary Outcome Measures
Post oper3tive pain
Measured by verbal question to patient/parents
Post operative pain
Measured by verbal question to patient/parents
Post operative pain
Measured by verbal question to patient/parents
Tenderness
Percussion test using back of a dental mirror
Tenderness
Percussion test using back of a dental mirror
Tenderness
Percussion test using back of a dental mirror
Swelling /sinus tract or fistula
Visual examination
Swelling /sinus tract or fistula
Visual examination
Swelling /sinus tract or fistula
Visual examination
Tooth mobility
Mobility test
Tooth mobility
Mobility test
Tooth mobility
Mobility test
Secondary Outcome Measures
Internal /External root resorption
Radiographic examination
Furcation involvement /radiolucency
Radiographic examination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05448937
Brief Title
Lesion Sterilization And Tissue Repair Versus Zinc Oxide And Eugenol For Treatment of Necrotic Primary Molars
Official Title
Clinical And Radiographic Evaluation Of Lesion Sterilization And Tissue Repair Versus Zinc Oxide And Eugenol For Treatment of Necrotic Primary Molars
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotic Primary Molars
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3 MIX
Arm Type
Experimental
Arm Description
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).
Arm Title
Zinc oxide and Eugenol Pulpectomy
Arm Type
Active Comparator
Arm Description
zinc oxide and eugenol (prevestdent pro™, egypt).
Intervention Type
Procedure
Intervention Name(s)
Lesion sterilization and tissue repair
Intervention Description
Pulp therapy for necrotic primary molars
Intervention Type
Procedure
Intervention Name(s)
zinc oxide and eugenol pulpectomy
Intervention Description
Pulp therapy for necrotic primary molars
Primary Outcome Measure Information:
Title
Post oper3tive pain
Description
Measured by verbal question to patient/parents
Time Frame
1 month
Title
Post operative pain
Description
Measured by verbal question to patient/parents
Time Frame
3 months
Title
Post operative pain
Description
Measured by verbal question to patient/parents
Time Frame
6 months
Title
Tenderness
Description
Percussion test using back of a dental mirror
Time Frame
1 month
Title
Tenderness
Description
Percussion test using back of a dental mirror
Time Frame
3 months
Title
Tenderness
Description
Percussion test using back of a dental mirror
Time Frame
6 months
Title
Swelling /sinus tract or fistula
Description
Visual examination
Time Frame
1 month
Title
Swelling /sinus tract or fistula
Description
Visual examination
Time Frame
3 months
Title
Swelling /sinus tract or fistula
Description
Visual examination
Time Frame
6 months
Title
Tooth mobility
Description
Mobility test
Time Frame
1 month
Title
Tooth mobility
Description
Mobility test
Time Frame
3 months
Title
Tooth mobility
Description
Mobility test
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Internal /External root resorption
Description
Radiographic examination
Time Frame
6 months
Title
Furcation involvement /radiolucency
Description
Radiographic examination
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esraa Mohamed Abdeltawab, B.D.S
Phone
01065074062
Email
esraa_abdeltawab94@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shereen Hassan El shamy, Lecturer
12. IPD Sharing Statement
Citations:
PubMed Identifier
29073902
Citation
Chen X, Liu X, Zhong J. Clinical and radiographic evaluation of pulpectomy in primary teeth: a 18-months clinical randomized controlled trial. Head Face Med. 2017 Oct 27;13(1):12. doi: 10.1186/s13005-017-0145-1.
Results Reference
background
PubMed Identifier
30289365
Citation
Luengo-Fereira J, Ayala-Jimenez S, Carlos-Medrano LE, Toscano-Garcia I, Anaya-Alvarez M. Clinical and Radiographic Evaluation of Formocresol and Chloramphenicol, Tetracycline and Zinc Oxide-Eugenol Antibiotic Paste in Primary Teeth Pulpotomies: 24 month follow up. J Clin Pediatr Dent. 2019;43(1):16-21. doi: 10.17796/1053-4625-43.1.4. Epub 2018 Oct 5.
Results Reference
background
PubMed Identifier
34937613
Citation
Moura J, Lima M, Nogueira N, Castro M, Lima C, Moura M, Moura L. LSTR Antibiotic Paste Versus Zinc Oxide and Eugenol Pulpectomy for the Treatment of Primary Molars with Pulp Necrosis: A Randomized Controlled Trial. Pediatr Dent. 2021 Nov 15;43(6):435-442.
Results Reference
background
PubMed Identifier
27790570
Citation
Navit S, Jaiswal N, Khan SA, Malhotra S, Sharma A, Mukesh, Jabeen S, Agarwal G. Antimicrobial Efficacy of Contemporary Obturating Materials used in Primary Teeth- An In-vitro Study. J Clin Diagn Res. 2016 Sep;10(9):ZC09-ZC12. doi: 10.7860/JCDR/2016/21883.8426. Epub 2016 Sep 1.
Results Reference
background
PubMed Identifier
26059708
Citation
Pramila R, Muthu MS, Deepa G, Farzan JM, Rodrigues SJ. Pulpectomies in primary mandibular molars: a comparison of outcomes using three root filling materials. Int Endod J. 2016 May;49(5):413-21. doi: 10.1111/iej.12478. Epub 2015 Jul 4.
Results Reference
background
PubMed Identifier
33087217
Citation
Coll JA, Dhar V, Vargas K, Chen CY, Crystal YO, AlShamali S, Marghalani AA. Use of Non-Vital Pulp Therapies in Primary Teeth. Pediatr Dent. 2020 Sep 15;42(5):337-349.
Results Reference
background
PubMed Identifier
31206571
Citation
Zacharczuk GA, Toscano MA, Lopez GE, Ortolani AM. Evaluation of 3Mix-MP and pulpectomies in non-vital primary molars. Acta Odontol Latinoam. 2019 Apr 1;32(1):22-28.
Results Reference
background
PubMed Identifier
29852056
Citation
Smail-Faugeron V, Glenny AM, Courson F, Durieux P, Muller-Bolla M, Fron Chabouis H. Pulp treatment for extensive decay in primary teeth. Cochrane Database Syst Rev. 2018 May 31;5(5):CD003220. doi: 10.1002/14651858.CD003220.pub3.
Results Reference
background
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Lesion Sterilization And Tissue Repair Versus Zinc Oxide And Eugenol For Treatment of Necrotic Primary Molars
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