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ABSTRACT
Background: Anxiety is a common issue for both patients and surgeons during dental procedures, which has led to increased interest in using sedatives in dentistry.

Objective: This study aimed to assess how effective clonazepam is in reducing pre-surgical anxiety in dental patients.
Methods: In this randomized controlled trial, 60 patients referred to the Department of Oral and Maxillofacial Surgery at Shiraz University of Medical Sciences participated. They were randomly assigned to receive either a single 2 mg dose of clonazepam or a placebo one hour before undergoing oral surgery. Both the participants and the evaluators were blinded to the treatment groups. Anxiety levels were measured using a Visual Analogue Scale (VAS), along with blood pressure, pulse rate, and oxygen saturation levels. Data were analyzed using the Chi-square test.

Results: The two groups were comparable in terms of age, gender, education, marital, and employment status (p > 0.05). Significant changes were observed in all anxiety-related indicators (VAS, blood pressure, pulse rate, and oxygen saturation) one hour after clonazepam administration in the treatment group (p < 0.05).

Conclusion: Clonazepam appears to be an effective medication for reducing dental anxiety with minimal side effects.

Benzodiazepines are widely used for their calming and sedative properties. These drugs work by enhancing the activity of gamma-aminobutyric acid (GABA), the brain’s primary inhibitory neurotransmitter. They also raise the activation threshold for neurons in the central nervous system.

Common benzodiazepines used in dental settings include diazepam, midazolam, and triazolam. Clonazepam, although primarily prescribed for seizures and panic disorders, is a long-acting benzodiazepine that may also help in managing anxiety during dental procedures. However, limited research has explored its use in this context, prompting this study.

Participants were randomly assigned using a table of numbers from 1 to 60, with odd-numbered individuals receiving a placebo and even-numbered participants receiving 2 mg of clonazepam (manufactured by Sobhan Daru, Tehran, Iran) one hour before surgery. Both participants and evaluators were blinded to the group assignments.

The study confirmed that the groups were similar in demographic characteristics (p > 0.05). Results showed a statistically significant reduction in anxiety levels, as measured by the VAS, in the clonazepam group one hour after administration (p < 0.001). Similar significant improvements were noted in blood pressure, pulse rate, and oxygen saturation (p < 0.001) after clonazepam intake compared to placebo.

Clonazepam, known for its anxiolytic, anticonvulsant, and muscle-relaxing effects, has been recognized for its quick onset and minimal adverse effects. These properties make benzodiazepines a preferred choice for managing anxiety in both children and adults. Midazolam and diazepam are commonly used for pediatric patients, and triazolam has also shown promising results.

The ideal dosage of these medications varies depending on the clinical goal—whether it’s sedation, anxiety control, or inducing amnesia—as well as the patient’s individual factors such as age, cooperation level, and anxiety severity. The route of administration (oral, IV, or rectal) also plays a role in determining effectiveness.

In this study, the use of clonazepam significantly reduced anxiety markers before oral surgery. The reduction in VAS scores (average change: 2.7±0.98) was slightly higher than results seen in previous studies, such as Chen et al. (2008), who reported a 2.5-point change using Mirtazapine.

Coldwell et al. investigated the effects of Alprazolam in varying doses and found that while 50 mg and 75 mg provided noticeable anxiety relief, they also caused memory impairment. Their findings suggest that alternative anxiolytics, like clonazepam, may be preferable in some cases.

In this study, none of the participants reported any side effects or adverse reactions after taking clonazepam. Since the experience level of the practitioner can influence a patient’s anxiety, future research is encouraged to involve more advanced and specialized dental care environments.

Some limitations of the current study include variation in clinician experience, the differing nature of dental procedures performed, and the inherent difficulty in accurately measuring anxiety levels. However, strengths of the study included a relatively large sample size, a consistent clinical setting, and the use of multiple methods to assess anxiety.

Conclusion

Despite certain limitations, the findings suggest that clonazepam is a well-tolerated and effective medication for reducing anxiety associated with oral surgery.

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In a separate clinical investigation, patients were enrolled based on having classic symptoms of Burning Mouth Syndrome (BMS). These symptoms included continuous, non-shooting burning sensations in the oral mucosa, with varying intensity, often accompanied by altered taste, dry mouth, or other oral discomforts, but without any visible lesions or a more suitable alternative diagnosis.

All patients were instructed to use 5 mL of a topical clonazepam solution, swishing for 5 minutes and then spitting it out, without swallowing. This was done two to four times daily. The treatment was administered as monotherapy. Patients on psychiatric medications were included only if their regimen had been stable for at least one month. Only those who completed a minimum of two weeks of clonazepam therapy before their first follow-up visit were included in the analysis—unless they stopped early due to an adverse reaction, in which case that reaction and the early termination were documented.

The clonazepam solution used in the study was specially compounded. For a 600 mL preparation, the formula included either 150 tablets of 2 mg clonazepam (for a 0.5 mg/mL concentration) or 30 tablets (for a 0.1 mg/mL concentration), combined with 6 mL of glycerin, 60 mL of propylene glycol, 240 mL of purified water, 6 mL of bubble gum flavor concentrate, and enough 70% sorbitol solution to reach a final volume of 600 mL.

Data Collection

Researchers gathered data from patient medical records, including demographics, current psychiatric medications, concurrent BMS treatments, BMS subtype (type 1, 2, or 3), the intensity of burning pain (using a 0–10 Numeric Rating Scale), the location of burning sensations, presence of other oral symptoms, treatment response, and any adverse effects. To minimize bias, only data from the first follow-up visit were analyzed, particularly to avoid skewed results in patients who were on the 0.5 mg/mL solution for longer periods.

The findings indicated that the topical clonazepam rinse was effective in relieving the burning sensations associated with BMS. Patients who used the 0.5 mg/mL solution—containing 2.5 mg of clonazepam per rinse—two to four times per day for a median duration of 7 weeks experienced significantly more pain relief than those using the 0.1 mg/mL solution (0.5 mg per rinse).

Treatment Response

Patient response to treatment was assessed using two self-reported outcome measures. The first focused on the percentage of improvement in burning symptoms. While a 30% reduction in pain intensity is generally considered clinically meaningful, most chronic pain studies aim for a 50% improvement to demonstrate substantial benefit and facilitate comparisons with existing literature.

In this study, topical clonazepam solution at a concentration of 0.5 mg/mL yielded a strong therapeutic response: 92% of patients reported at least a 50% improvement in symptoms, with a median improvement of 75%. These results significantly surpassed the 50% benchmark. In contrast, only 41% of patients using the 0.1 mg/mL solution reached the 50% improvement threshold, with a median improvement of just 32.5%—which did not exceed the clinical significance cutoff of 30%.

These findings suggest that the higher concentration (0.5 mg/mL) of topical clonazepam is more effective than previously reported topical treatments for Burning Mouth Syndrome (BMS). For example, Gremeau-Richard et al. found that 50% of patients experienced at least 50% symptom relief after using 1-mg clonazepam tablets three times a day for two weeks. Another open-label pilot study by de Castro and Ribeiro-Rotta, which used a 1 mg/10 mL clonazepam rinse three times daily for 14 days, showed that 12 out of 18 patients (two-thirds) reported symptomatic relief, with half experiencing improvements of 50% or more.

The second measure evaluated the change in peak burning severity over the week preceding the follow-up visit, using a 0–10 Numeric Rating Scale. Among patients using the 0.5 mg/mL solution, the median reduction in pain was 6 points (mean reduction: 5.7 points)—a substantial improvement. Furthermore, no ongoing adverse drug reactions were reported among those who continued therapy without any dose adjustments.

Study Limitations

Because patients used varying rinsing frequencies (from twice to four times per day), their actual daily dosage differed, limiting the ability to determine an optimal therapeutic dose. Additionally, clonazepam blood levels were not monitored, so the impact of systemic absorption on side effects or effectiveness remains unclear.

The follow-up period also varied widely, ranging from 3 weeks to 5.5 months, and in one case extended to a year (median: 7 weeks). The decision not to restrict follow-up length helped reduce selection bias and maximize the available data. Importantly, the primary results remained consistent even when data from follow-ups beyond 9 weeks were excluded.

Although the sample size was relatively small—due largely to incomplete data and patient dropout—the study’s strict inclusion criteria helped ensure a relatively uniform participant group. While selection bias cannot be entirely ruled out, the similar baseline characteristics between groups provide some reassurance about the internal validity of the findings.