Chewing Gum as a Therapeutic Intervention for the Management of Hypersalivation

Official title

Chewing Gum as a Therapeutic Intervention for the Management of Hypersalivation : a Pilot Study L'Utilisation du Chewing-gum Dans la Prise en Charge de l'hypersialorrhée : Une étude Pilote

Overview

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.

Detailed description

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.

Interventions

• Behavioral chewing gum mastication
  chewing gum mastication

Primary outcome measures

• Salivary flow measured using the Drooling Severity and Frequency Scale (DSFS) in relation to chewing gum mastication [Time frame: 4 weeks]

Secondary outcome measures (4)

• 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]

Eligibility criteria

Inclusion criteria

• 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.
• With or without pharmacological management of hypersalivation.
• Individuals under legal protective measures may be included.
• Provided written informed consent prior to participation.

Exclusion criteria

• 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)
• Oral/dental condition preventing mastication

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07158359 · 2025-A00525-44 · IDRCB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗