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Chewing Gum as a Therapeutic Intervention for the Management of Hypersalivation

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07158359
Acronym
Chew Daily
Enrollment
46
Registered
2025-09-05
Start date
2025-09-30
Completion date
2026-12-31
Last updated
2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypersialorrhea (Excessive Salivation), Psychiatric Disorders

Keywords

Rehabilitation, occupational therapy, pilot study, chewing gum mastication, non-pharmacological treatment

Brief summary

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

BEHAVIORALchewing gum mastication

chewing gum mastication

Sponsors

Centre Hospitalier de Cadillac
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This study falls within the field of Research Involving Human Participants. It is classified as Category 2: interventional research involving minimal risk. The study is designed as a prospective, longitudinal investigation.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Salivary flow measured using the Drooling Severity and Frequency Scale (DSFS) in relation to chewing gum mastication4 weeks

Secondary

MeasureTime frame
Quality of life, evaluated with the Clinical Global Impression (CGI), was assessed pre- and post-experimental phase4 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?4 weeks
Use of pharmacological agents associated with adverse effects will be monitored through prescription tracking.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?4 weeks

Contacts

Primary ContactAlix AL Lavandier, PhD
alix.lavandier@ch-cadillac.fr+33556765148

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026