Chewing Gum as a Therapeutic Intervention for the Management of Hypersalivation

NCT ID: NCT07158359

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-12-31

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.

Conditions

Hypersialorrhea (Excessive Salivation); Psychiatric Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group assigned to a swallowing rehabilitation program involving chewing gum mastication

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

Group Type: EXPERIMENTAL

chewing gum mastication

Intervention Type: BEHAVIORAL

chewing gum mastication

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

chewing gum mastication

chewing gum mastication

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier de Cadillac

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Alix AL Lavandier, PhD

Role: CONTACT

alix.lavandier@ch-cadillac.fr

+33556765148 ext. +33

Other Identifiers

IDRCB

Identifier Type: OTHER

Identifier Source: secondary_id

2025-A00525-44

Identifier Type: -

Identifier Source: org_study_id