Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 27, 2025
Open Peer Review Period: May 27, 2025 - Jul 22, 2025
Date Accepted: Dec 17, 2025
(closed for review but you can still tweet)
Comparing the Effectiveness of Atropine Sulfate and Acacia Catechu in Reducing Salivary Secretion During Dental Procedures: Protocol for a Randomized Controlled Trial
Background:
Sialorrhea, or excessive salivation, can be a major problem during a number of dental operations. It can impair vision, increase chair time, and perhaps jeopardize the effectiveness of treatments. To treat this illness, pharmacological treatments such as atropine sulfate are frequently used. However, there has not been much research done on natural substitutes like for this function.
Objective:
The aim of this study is to compare and evaluate the effectiveness of atropine sulfate and in reducing salivary secretion in patients undergoing restorative dental procedures.
Methods:
A randomized controlled trial will be conducted involving 160 participants undergoing restorative dental treatments. Participants will be randomly assigned to receive either atropine sulfate or . Salivary flow will be measured preintervention and postintervention. The primary statistical analysis will use analysis of covariance, with postintervention salivary flow as the dependent variable and baseline salivary flow as a covariate. If a placebo arm is included, group differences will be analyzed using 1-way ANOVA followed by Tukey post hoc tests. Paired tests will be used only for within-group pre-post comparisons.
Results:
Ethical approval was obtained in March 2025. Participant recruitment is scheduled to begin in June 2026 and is expected to be completed by December 2026, with final data collection anticipated by February 2027. It is anticipated that both interventions will reduce salivary flow, with atropine sulfate demonstrating greater efficacy but more side effects, and offering a better side-effect profile and higher patient acceptability.
Conclusions:
The trial will provide comparative evidence on the efficacy and safety of a pharmacological and a natural anticholinergic agent. If proves effective, it may offer a viable, better-tolerated alternative for salivary control in clinical dental settings.
Trial Registration:
Clinical Trials Registry – India (CTRI) CTRI/2025/06/089468; https://tinyurl.com/5b4ft3cv
International Registered Report Identifier (Irrid):
PRR1-10.2196/78119
Citation
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