Lesion sterilisation and tissue repair with chloramphenicol, tetracycline, zinc oxide-eugenol paste compared to zinc oxide-eugenol pulpectomy in primary molars: Two-year follow-up findings of a multicentre non-inferiority randomised clinical trial
- 1Department of Pediatric Dentistry, School of Dentistry, Universidade de Sao Paulo (USP), Sao Paulo, Brazil
Abstract
Background: Chloramphenicol, tetracycline, zinc oxide (CTZ) paste has been widely used, particularly in Latin America, in Lesion Sterilization and Tissue Repair (LSTR) procedures in primary molars. However, reports on its long-term efficacy are scarce. Aim: This multicentre non-inferiority randomised trial compared the efficacy of LSTR using CTZ paste with conventional zinc oxide-eugenol (ZOE) pulpectomy in primary molars. Design: 199 primary molars from children aged 3 to 9 years were randomised to the CTZ or ZOE groups. The primary outcome was clinical and radiographic success at 24 months. Clinical time, children's behaviour, immediate discomfort and postoperative pain were also evaluated. The main analysis followed the intention-to-treat (ITT) principle, comparing success proportions with the Miettinen-Nurminen method, considering a prespecified non-inferiority margin of 15% (p < 0.05). Results: Overall success rates in the ITT population were 64.3% for CTZ and 58.7% for ZOE, with a difference of 5.6% (95% CI: -9.3 to 20.4; p<0.01). Mean; standard deviation clinical time was significantly shorter in CTZ (36.3; 9.8 min) than in ZOE (63.0; 16.3 min) (p<0.01). Children's behaviour, immediate discomfort and postoperative pain were similar between groups (p>0.05). Conclusion: LSTR with CTZ paste was non-inferior to conventional ZOE pulpectomy after 24 months of follow-up.
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BibTeX
@misc{santos2026lesion,
title = {{Lesion sterilisation and tissue repair with chloramphenicol, tetracycline, zinc oxide-eugenol paste compared to zinc oxide-eugenol pulpectomy in primary molars: Two-year follow-up findings of a multicentre non-inferiority randomised clinical trial}},
author = {P. S. Santos and T. Ramos and G. d. C. Fernandes and N. M. Oliveira and A. O. Rocha and F. C. Vitali and F. F. Galdino and R. P. S. Marques and V. L. V. M. Soviero and C. M. Santana and T. K. d. S. Fidalgo and M. Cardoso and F. M. Mendes},
howpublished = {medRxiv},
year = {2026},
month = nov,
doi = {10.64898/2026.11.04.26367310},
url = {https://www.medrxiv.org/content/10.64898/2026.11.04.26367310v1},
note = {CC BY-NC-ND},
}
RIS
TY - UNPB
TI - Lesion sterilisation and tissue repair with chloramphenicol, tetracycline, zinc oxide-eugenol paste compared to zinc oxide-eugenol pulpectomy in primary molars: Two-year follow-up findings of a multicentre non-inferiority randomised clinical trial
AU - P. S. Santos
AU - T. Ramos
AU - G. d. C. Fernandes
AU - N. M. Oliveira
AU - A. O. Rocha
AU - F. C. Vitali
AU - F. F. Galdino
AU - R. P. S. Marques
AU - V. L. V. M. Soviero
AU - C. M. Santana
AU - T. K. d. S. Fidalgo
AU - M. Cardoso
AU - F. M. Mendes
PY - 2026
DA - 2026/11/04
PB - medRxiv
DO - 10.64898/2026.11.04.26367310
UR - https://www.medrxiv.org/content/10.64898/2026.11.04.26367310v1
AB - Background: Chloramphenicol, tetracycline, zinc oxide (CTZ) paste has been widely used, particularly in Latin America, in Lesion Sterilization and Tissue Repair (LSTR) procedures in primary molars. However, reports on its long-term efficacy are scarce. Aim: This multicentre non-inferiority randomised trial compared the efficacy of LSTR using CTZ paste with conventional zinc oxide-eugenol (ZOE) pulpectomy in primary molars. Design: 199 primary molars from children aged 3 to 9 years were randomised to the CTZ or ZOE groups. The primary outcome was clinical and radiographic success at 24 months. Clinical time, children's behaviour, immediate discomfort and postoperative pain were also evaluated. The main analysis followed the intention-to-treat (ITT) principle, comparing success proportions with the Miettinen-Nurminen method, considering a prespecified non-inferiority margin of 15% (p < 0.05). Results: Overall success rates in the ITT population were 64.3% for CTZ and 58.7% for ZOE, with a difference of 5.6% (95% CI: -9.3 to 20.4; p<0.01). Mean; standard deviation clinical time was significantly shorter in CTZ (36.3; 9.8 min) than in ZOE (63.0; 16.3 min) (p<0.01). Children's behaviour, immediate discomfort and postoperative pain were similar between groups (p>0.05). Conclusion: LSTR with CTZ paste was non-inferior to conventional ZOE pulpectomy after 24 months of follow-up.
ER -