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)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
“A Protocol for a Randomized Controlled Trial Comparing the Effectiveness of Atropine Sulphate and Acacia Catechu in Reducing Salivary Secretion during Dental Procedures.”
ABSTRACT
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 sulphate are frequently employed. However, there hasn't been much research done on natural substitutes like Acacia catechu for this function.
Objective:
To compare and evaluate the effectiveness of Atropine sulphate and Acacia catechu 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 Sulphate or Acacia Catechu. Salivary flow will be measured pre- and post-intervention. Statistical analysis will be performed using paired t-tests and ANOVA. This protocol outlines the methodology and planned analyses.
Results:
It is anticipated that both interventions will reduce salivary flow, with atropine sulphate demonstrating greater efficacy but more side effects, and Acacia catechu 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 Acacia catechu proves effective, it may offer a viable, better-tolerated alternative for salivary control in clinical dental settings. Clinical Trial: This study has been submitted to the Clinical Trials Registry – India (CTRI) and is currently under review (Acknowledgment Number: REF/2025/04/104969). The trial will be updated with the final registration number once approved.
Citation
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Copyright
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