Salivary secretion is essential for oral health and is mainly regulated by parasympathetic neural control via facial and glossopharyngeal nerves. When these nerves are activated, they release neurotransmitters like acetylcholine. Controlling saliva is essential in prosthodontic procedures to maintain a dry and clean environment, which leads to better precision, comfort, and long-term success of prosthetic treatments. However, excessive salivation (sialorrhea) during oral surgical procedures can pose challenges to procedures such as taking impressions, lower arch surgery, and placing restorations. During crown preparation, controlling the amount of saliva is essential to maintain a dry field. It can interfere with impression-making, bonding procedures, and proper fitting of the crown.

The white crystalline alkaloid atropine was originally synthesized from Atropa belladonna. It inhibits the normal functioning of the M-choline receptor. Salivation is caused by the activation of muscarinic subtype 3 receptors [1,2]. The muscarinic receptors of the salivary glands are bound by the active neurotransmitter acetylcholine. Thus, it is well known that atropine and other cholinergic muscarinic receptor antagonists can be used to treat hypersecretion by the gland [3].

For oral administration of atropine in adults, a pharmacokinetics investigation was done by Beermann et al [4] using atropine that was radiolabelled. The absorption of atropine via the oral route in children was examined in two investigations [5,6]. Numerous alternative regimen tactics have been documented in the literature to specify atropine dosages and frequencies based on the patient’s clinical status. Atropine sulfate delivered sublingually has several benefits, including ease of administration and fast mucosal membrane absorption. It is affordable, reversible, and does not require any particular skills to use [7]. Additionally, it is often more accepted by patients than invasive methods like injections or other tools. Low dosages of atropine given orally or sublingually may help these patients. Atropine side effects include nausea, vomiting, dry mouth, impaired vision, and tachycardia. There is limited research on the safety and pharmacokinetics of atropine given sublingually. Notwithstanding the low dosages used in this application, little is known about atropine’s systemic absorption when taken sublingually, necessitating extra caution when it comes to the possibility of side effects.

In contrast, natural plant-based alternatives with astringent properties are gaining attention in modern dentistry for their therapeutic potential and lower risk profiles.

For many years, Ayurveda has used the deciduous Acacia catechu (L.f.) Willd. tree, which belongs to the Fabaceae family, to cure and prevent a wide range of illnesses and conditions [8]. Several parts of Acacia catechu have an exceptionally high concentration of flavonoids, tannins, and phenolic compounds, such as procyanidin, quercetin, catechin, epicatechin, epigallocatechin, and taxifolin [9]. These active ingredients, including catechin and epicatechin, have important anti-inflammatory and antioxidant properties; tannins are thought to cause the astringent effects on the body [10], reducing secretions like saliva. These properties suggest that Acacia catechu may help reduce salivary secretion through local action on the oral mucosa, without the systemic effects seen with pharmacological agents like atropine. By assessing both clinical outcomes and patient comfort, this study seeks to determine whether Acacia catechu may serve as a viable, natural alternative to conventional anticholinergic agents in dental practice.

The aim of this study is to compare and evaluate the effectiveness of atropine sulfate and Acacia catechu in reducing salivary secretion in patients undergoing restorative dental procedures.

The objectives of the study are to assess the amount of salivary secretion before and after intervention with atropine sulfate and Acacia catechu and to compare the efficacy of both agents. Additionally, the study aims to evaluate patient acceptability and tolerance for each intervention.

This is a parallel-group, randomized, double-blind, controlled trial with 1:1 allocation. A total of 160 participants undergoing restorative dental procedures will be recruited and randomized into 2 equal groups to receive either atropine sulfate or Acacia catechu.

Group A participants will receive 1% w/v atropine sulfate drops (commercial preparation) sublingually, at a dose of 0.01 mg/kg, 30 minutes prior to the dental procedure.

Group B participants will receive an aqueous extract of Acacia catechu prepared from dried heartwood. To prepare the extract, 100 g of powdered Acacia catechu will be boiled in 1000 mL of distilled water until reduced to one-third of its original volume. The decoction will be filtered, cooled, diluted (2‐5% w/v), and stored under sterile conditions at 4°C until use.

The Acacia catechu extract w/v) will be administered sublingually using a sterile dropper, at a dose of 1 mL/kg, 30 minutes before the dental procedure. Participants will hold the extract under the tongue for about 2 minutes to allow mucosal absorption before swallowing.

All participants will be seated comfortably in the dental chair and will be instructed to rinse with plain water before baseline measurements. Unstimulated saliva will be collected over a 5-minute period using the spit method into a preweighed, sterile container. Baseline heart rate and blood pressure will be recorded using a digital monitor.

To maintain blinding, participants and outcome assessors will not be informed about which intervention group the participant was assigned to. The preparation of both solutions will be handled by an unblinded third party. The principle of intent-to-treat will be applied, and all participants will be required to provide written informed consent before enrollment. Before the study begins, the patient’s complete medical, dental, and demographic history will be recorded. The data will be tabulated and statistically evaluated using SPSS (version 21; IBM Corp) software, while the student t test will be used for intergroup analysis. The schedule of enrollment, interventions, and assessments is outlined in Table 1, following SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines.

All data will be initially recorded on paper case report forms. Data will be digitized using Microsoft Excel (Microsoft Corp) and stored on a password-protected institutional computer system. Each participant will be assigned a unique ID to maintain confidentiality. A double-entry method will be used to minimize data entry errors. Regular audits will be conducted to ensure accuracy, completeness, and compliance.

To assess variation in salivary secretion among the study groups, the data will first be summarized using descriptive statistics, including mean, standard deviation, and range. Categorical variables such as the presence of adverse effects will be compared using the χ² test.

For the primary analysis, an analysis of covariance will be performed, with postintervention unstimulated salivary flow as the dependent variable and baseline salivary flow as the covariate. This method provides an adjusted and robust comparison of treatment effects.

If the study includes three arms (atropine, Acacia catechu, and placebo), overall group differences will be evaluated using 1-way ANOVA, followed by a Tukey post hoc test to identify pairwise differences.

Within-group (preintervention vs postintervention) changes will be analyzed using paired t tests, whereas comparisons between two independent groups (eg, atropine vs Acacia) will use unpaired t tests only for exploratory purposes.

All analyses will be performed using SPSS (version 27.0; IBM Corp) and GraphPad Prism (version 7.0; GraphPad Software). Statistical significance will be set at P<.05.

The institutional review board has granted ethical approval [DMIHER(DU)/IEC/2025/549]. There will be safety monitoring for adverse drug reactions. Informed consent will be obtained from all participants. The study will follow strict guidelines for the ethical handling of patients.

Upon completion of the trial, results will be submitted to peer-reviewed journals and presented at scientific conferences. Participants will be informed of key findings upon request.