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NCT Number: NCT07158359

Chewing Gum as a Therapeutic Intervention for the Management of Hypersalivation

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chewing gum mastication

Behavioral

chewing gum mastication

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alix AL Lavandier, PhD

CONTACT

[email protected]

+33556765148 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Cadillac

Other

Registry information

Official study 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

Acronym: Chew Daily

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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