A 1-year Clinical and Radiographic Assessment of Regenerative Endodontic Therapy for Necrotic Primary Molars: A Randomized controlled Trial

Abstract

Background: Preservation of necrotic primary teeth is important. Pulpectomy is the gold standard treatment in this situation. Reinfection is the main cause of failure in pulpectomy. The application of regenerative endodontic therapy in mature teeth has the rationale of restoring dental-pulp-like tissue and preventing reinfection.

Aims and objectives: The current study was designed to clinically and radiographically assess regenerative endodontics therapy in necrotic primary molars in comparison to zinc oxide eugenol (ZOE) pulpectomy.

Materials and methods: A double-blinded randomized controlled trial with three parallel arms and a 1:1:1 allocation ratio was conducted. A total of 54 necrotic primary molars in 39 healthy children aged 4-7 years old were randomly allocated as follows group I-control group, in which ZOE pulpectomy was performed. Group II and III-experimental groups, in which regenerative endodontic therapy (RET) was performed. Modified triple antibiotic paste (mTAP) and Metapex™ were used as intracanal medicaments in groups II and III, respectively. Clinical and radiographic assessments were recorded at baseline, 6 and 12 months. Chi-squared and Fisher's exact tests were used to compare the qualitative data, while Friedman's test was used to study the changes by time within each group.

Results: Nonstatistically significant differences were reported between the three groups at the 6 and 12 months follow-ups regarding the clinical or radiographic assessment (p-value = 0.327 and effect size = 0.22), (p-value = 0.055 and effect size = 0.118), respectively.

Conclusion: Regenerative endodontic therapy (RET) yielded comparable results to pulpectomy. However, the use of 5 mg/mL mTAP in RET represented the highest level of clinical as well as radiographic insignificant failure.

Clinical significance: Regenerative endodontic therapy (RET) provides an acceptable biological alternative to pulpectomy.

Trial registration: The protocol was registered at ClinicalTrial.gov with the registration number (NCT04190914). 12/5/2019.

How to cite this article: Abdelmoneim DD, Abdelaziz AM, Allam GG, et al. A 1-year Clinical and Radiographic Assessment of Regenerative Endodontic Therapy for Necrotic Primary Molars: A Randomized controlled Trial. Int J Clin Pediatr Dent 2023;16(2):295-301.

Keywords: Canal irrigants; Canal medication; Nonvital primary teeth; Pulpectomy; Randomized control trial; Regenerative endodontic procedure.