An interventional study of chewing gum mastication in Hypersialorrhea (Excessive Salivation) and Psychiatric Disorders, sponsored by Centre Hospitalier de Cadillac. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by Centre Hospitalier de Cadillac · Not applicable, Interventional, and Treatment
Psychiatric disorders often require specific treatments, usually involving medications called psychotropic drugs. While effective, these medications can cause significant side effects. One of the most common is hypersalivation (excess saliva), which can make swallowing difficult and be very uncomfortable in daily life.
Current medication-based solutions are often not very effective and may cause additional side effects. For this reason, we are exploring a different approach: using chewing gum as a form of rehabilitation.
The goal of this study is to determine whether chewing gum can help reduce excessive saliva. To do this, we will compare two groups: one that will follow a swallowing rehabilitation program including chewing gum, and another that will not.
We hope this simple, non-drug-based approach will improve the management of hypersalivation. More broadly, this research aims to highlight innovative and accessible solutions in psychiatry, showing that alternative strategies-sometimes very simple ones-can also be effective.
Introduction Psychiatric disorders necessitate highly specific therapeutic approaches. Psychotropic medications, which are frequently prescribed in these settings, are well known for their substantial burden of adverse drug reactions. Among these, hypersialorrhea (excessive salivation) is a particularly common and disabling side effect, often associated with swallowing disturbances. Current pharmacological alternatives proposed to address this condition remain of limited efficacy and may themselves induce additional adverse effects. In light of these limitations, a rehabilitative, non-pharmacological intervention such as chewing gum mastication may represent a promising strategy.
Objective The primary objective of this pilot study is to assess the effect of chewing gum mastication on hypersialorrhea in patients receiving psychotropic medications.
Methods A randomized controlled trial will be conducted, comparing two groups: an experimental group undergoing a swallowing rehabilitation program incorporating chewing gum mastication, and a control group receiving no chewing-gum-based intervention.
Expected Results This study is expected to provide preliminary evidence supporting the clinical utility of chewing gum mastication as a non-pharmacological approach for the management of hypersialorrhea. Beyond its direct clinical implications, the study aims to promote awareness of innovative, unconventional, yet potentially effective therapeutic strategies in psychiatry, thereby fostering further research in this field.
Keywords Rehabilitation; occupational therapy; psychiatry; pilot study; chewing gum mastication; clinical management; non-pharmacological treatment.
60 studies on the registry are indexed under Sialorrhea; 5 are open to participants now.
This study's planned enrollment of 46 is above the median of 31 across 44 interventional studies indexed under Sialorrhea.
Browse Sialorrhea studies →Centre Hospitalier de Cadillac is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each participant will receive a rehabilitation session (including chewing gum mastication) three times per week over a four-week period. Each session will last 15 minutes (i.e., 10 minutes of mastication followed by a 5-minute waiting period prior to reassessment). The 10-minute mastication period was determined based on clinical feedback from patients regarding this practice. Rehabilitation sessions will always take place at least 30 minutes after meals. During each mastication session, the participant will be observed in a quiet room, with a comic book available for distraction. Hypersialorrhea will be assessed three times per session using the DSFS scale: immediately before chewing gum mastication, at the end of the mastication period, and 5 minutes thereafter. The rehabilitation program will run over four weeks, from Monday to Friday, corresponding to 12 non-consecutive days. The four-week duration was chosen in accordance with standard occupational therapy clinical practice. In
Behavioral: chewing gum mastication
For the control group, which will not receive any rehabilitation, the same schedule will be followed. Each participant will be seen three times per week for 15 minutes. During these observation sessions (no intervention, absence of any rehabilitation), hypersialorrhea will be assessed three times using the DSFS scale: immediately before, at the end of the 10-minute period, and 5 minutes thereafter. During these observation sessions, participants will be placed in a quiet room with a comic book available for distraction. The observation period will span four weeks, corresponding to 12 non-consecutive days. In parallel, the healthcare team will be asked to respond three times per week to a single adherence-related question during the scheduled sessions.
chewing gum mastication
Salivary flow measured using the Drooling Severity and Frequency Scale (DSFS) in relation to chewing gum mastication
Time frame: 4 weeks
Quality of life, evaluated with the Clinical Global Impression (CGI), was assessed pre- and post-experimental phase
Time frame: 4 weeks
Patient adherence to medication will be assessed weekly by the healthcare team using a single dichotomous question: "Did the patient demonstrate opposition to taking their medication related to hypersalivation?"
Time frame: 4 weeks
Use of pharmacological agents associated with adverse effects will be monitored through prescription tracking.
Time frame: 4 weeks
Tolerance and safety of chewing gum as a therapeutic intervention will be evaluated by the investigative team at each session using two dichotomous questions: "Did you observe any tolerance or safety issues during chewing gum mastication in this session?
Time frame: 4 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2025; primary completion for Sep 2026, 12 months later.
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This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier de Cadillac