Abstract
Aim
To assess the effectiveness of topically-administered haemocoagulase (batroxobin) (HC) following dental extractions in children.
Design
Split-mouth design, where either HC (test) or Normal Saline (control) (NS) was administered to children (5–9 years) requiring bilateral extractions of primary molars. Participants were randomised to (i) extraction sequence; (ii) test-solution administered thereafter. Outcome measure: time taken (in seconds) for complete cessation of bleeding.
Results
Thirty participants completed the trial receiving HS (n = 30) and NS (n = 30). No adverse events were reported. Time to bleeding cessation was lower in HS group (82.5 ± 13.99 s) than NS group (240.5 ± 54.34 s). Difference between groups (paired t test) was statistically very highly significant (P = 0.000).
Conclusion
Topical HC produced significant reductions in time for haemostasis and was clinically effective in controlling haemorrhage from extraction wounds in children. HC may be favourably utilised by paediatric dentists, especially with pre-cooperative or special-healthcare-needs patients, improving patient care.
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Acknowledgements
The authors thank Mrs. Pallavi Nachinolkar (Statistician) for her assistance with Statistical computations, and Dr. Vinayak Kamath (Department of Public Health Dentistry) for his advice on study design and sample-size calculations. We also place on record our appreciation of the parents and children who participated in the study.
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We declare that all authors have made substantial contributions. DFS and ESB conceived the idea, collected the data, and analysed the data; DFS and SR critically reviewed and formulated the study design, and analysed the data; DFS led the manuscript writing; all the authors revised and approved the manuscript.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional (Institutional Review Board Certificate Number ETHICAL COMM./GDCH/2017-1/PEDO-1) and national research committee (Registration Number: CTRI/2017/09/009784) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Trial status and registration: Closed trial. Clinical Trials Registry of India, Registration number: CTRI/2017/09/009784.
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Swamy, D.F., Barretto, E.S. & Rodrigues, J.S.L. Effectiveness of topical haemocoagulase as a haemostatic agent in children undergoing extraction of primary teeth: a split-mouth, randomised, double-blind, clinical trial. Eur Arch Paediatr Dent 20, 311–317 (2019). https://doi.org/10.1007/s40368-018-0406-0
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DOI: https://doi.org/10.1007/s40368-018-0406-0