Chewing Gum as a Therapeutic Intervention for the Management of Hypersalivation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentre Hospitalier de Cadillac

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults aged 18 to 65 years.

Hospitalized at Cadillac Hospital, either in full inpatient care or at the rehabilitation facility, excluding the UHSA.

Experiencing iatrogenic hypersalivation induced by psychotropic medications.

Salivary flow causing functional impairment for the patient, or observed by family members or healthcare providers.

Disqualifiers

Anatomical/morphological anomaly affecting mastication/swallowing

Swallowing disorder of organic etiology (e.g., neurological deficit due to stroke, neurodegenerative disease, oropharyngeal surgery, etc.)

Known risk of aspiration with liquids

Patient refusal of chewing gum or inability to obtain consent (e.g., non-communicative patients)

Trial design

Design model

Parallel

Treatments tested in this trial

  • chewing gum mastication

    Behavioral

    chewing gum mastication

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Experimental group assigned to a swallowing rehabilitation program involving chewing gum masticationExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Salivary flow measured using the Drooling Severity and Frequency Scale (DSFS) in relation to chewing gum mastication

Time frame
4 weeks

Secondary outcomes

1

Quality of life, evaluated with the Clinical Global Impression (CGI), was assessed pre- and post-experimental phase

Time frame
4 weeks
2

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
3

Use of pharmacological agents associated with adverse effects will be monitored through prescription tracking.

Time frame
4 weeks
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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