Clinical trial NCT05448937: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Necrotic Primary Molars
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post oper3tive pain
timeFrame: 1 month
measure: Post operative pain
timeFrame: 3 months
measure: Post operative pain
timeFrame: 6 months
measure: Tenderness
timeFrame: 1 month
measure: Tenderness
timeFrame: 3 months
measure: Tenderness
timeFrame: 6 months
measure: Swelling /sinus tract or fistula
timeFrame: 1 month
measure: Swelling /sinus tract or fistula
timeFrame: 3 months
measure: Swelling /sinus tract or fistula
timeFrame: 6 months
measure: Tooth mobility
timeFrame: 1 month
measure: Tooth mobility
timeFrame: 3 months
measure: Tooth mobility
timeFrame: 6 months
Secondary outcomes:
measure: Internal /External root resorption
timeFrame: 6 months
measure: Furcation involvement /radiolucency
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
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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.
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.
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.
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.