DroolingSIALOBOTNCT07067762
Botulinum Toxin Injections Into the Salivary Glands of Cerebrospinal Children With Chronic Sialorrhea
An observational study of Drooling and Brain Injuries, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
French Health Authority describes sialorrhea (or drooling) as uncontrolled loss of saliva through the lips. Drooling is considered pathological after the age of three. It most often reflects an alteration in the control of orofacial muscular coordination. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Drooling, Brain Injuries, Chronic Sialorrhea
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2025to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: brain-injured children from 3 to 15 years of age with chronic sialorrhea.
Who may be able to join
- Brain injured children aged 3 to 15, treated in the PRM department of Besançon University Hospital between 2021 and 2025, with chronic invalidating Sialorrhea for more than three months at the time of treatment, treated with botulinum toxin injections in the salivary glands.
- Minimal weight of 12 kg,
- Stopped drooling treatments three months before injections,
- Subject (holders of parental authority) does not refuse the use of personal data
- Registration with French social security plan.
Who cannot join
- Previous treatment with botulinum toxin in the salivary glands,
- Treatment with botulinum toxin for another indication in the previous three months,
- Contraindication to botulinum toxin injections.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Botulinum Toxin Injections in Salivary Glands of Brain-injured Children With Chronic Sialorrhea: a Retrospective Study.
French Health Authority describes sialorrhea (or drooling) as uncontrolled loss of saliva through the lips. Drooling is considered pathological after the age of three. It most often reflects an alteration in the control of orofacial muscular coordination. It is frequently observed in patients (adults and children) with neurological disorders. Among these neurological conditions, cerebral palsy is the most important cause of drooling in children. According to series, the incidence of drooling in children with cerebral palsy ranges from 10 to 58%, of whom 15% are considered to present with severe drooling.
Two types of drooling must be distinguished: anterior drooling (externalization of saliva through the lips) and posterior drooling (flow of saliva through the oropharynx that can reach the lungs by the trachea). Anterior drooling is responsible for skin erosions, fungal infections and dehydration, as well as low self-esteem and social rejection. Posterior sloughing, on the other hand, is not directly visible (unlike anterior sloughing).
Read more
Posterior bavage is not directly seen (unlike anterior bavage). However, should be noticed, as there is an increased risk of inhalation pneumonitis. Drooling is thus responsible for major social and emotional disturbances in affected children, as well as in parents/guardians/primary caregivers, justifying appropriate management. Many assessment tools are available to the clinician.
The subjective measures assess the social and emotional impact of daily life on patients and their families. For example, the Drooling Impact Scale (D.I.S.) was created by the salivary control department at Melbourne Hospital, Australia to add a subjective dimension to scales that do not assess the daily impact of drooling. There is no currently consensus method for assessing drooling importance or severity
Lot of treatment cas be proposed to patients with chornic sialorrheaalorrhea: non-drug treatments, medication (systemic or focal) and surgical treatments. Non-drug treatments consist of targeted rehabilitation by speech therapists and dental care. There is a wide range of rehabilitation techniques. However, this rehabilitation can only be effective in patients with the appropriate cognitive functions to enable them to understand and continue the exercises. Currently, there is little evidence of the effectiveness of these techniques in the scientific literature. Medication are used for their anticholinergic effect. However, due to their non-selective effect and systemic effects, medication are frequently associated with severe side-effects. These are sometimes more serious than sialorrhea, which limits the use of these molecules.
Botulinum toxin, injected specifically in the main salivary glands, has been used to treat drooling since 1997, thanks to its focal anticholinergic effect. Its efficacy has been demonstrated by randomized clinical trials: botulinum toxin has been shown to significantly reduce the frequency and severity of drooling. However, few studies have looked specifically at the efficacy of botulinum toxin in children in terms of functional and social repercussions using a subjective measurement scale.
The aim of the SIALOBOT study was to demonstrate the efficacy of botulinum toxin in the salivary glands of children with chronic sialorrhea, according to a subjective measure of daily functional impact
- Conditions
- Drooling, Brain Injuries, Chronic Sialorrhea, Children, Only, Botulinum Toxin
- Medical subject headings
- Sialorrhea, Brain Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of botulinum toxin in the treatment of drooling
Use of the drooling impact scale to measure the efficacy of botulinum toxin on the frequency, severity and daily impact of drooling in brain injured children with chronic sialorrhea Each question is answered on a visual analogue scale (1-10) giving a score/100. 100 is the worst score (drooling had worsened).
Measured: Five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start19 May 2025
- Primary completion1 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DroolingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067762
- Sponsor's protocol ID
- 2025/961
- Acronym
- SIALOBOT
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Injections in Salivary Glands of Brain-injured Children With Chronic Sialorrhea: a Retrospective Study.
- ClinicalTrials.gov ID
- NCT07067762
- Acronym / sponsor ID
- SIALOBOT / 2025/961
- Conditions
- Drooling, Brain Injuries, Chronic Sialorrhea, Children, Only, Botulinum Toxin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
French Health Authority describes sialorrhea (or drooling) as uncontrolled loss of saliva through the lips. Drooling is considered pathological after the age of three. It most often reflects an alteration in the control of orofacial muscular coordination. It is frequently observed in patients (adults and children) with neurological disorders. Among these neurological conditions, cerebral palsy is the most important cause of drooling in children. According to series, the incidence of drooling in children with cerebral palsy ranges from 10 to 58%, of whom 15% are considered to present with severe drooling.
Two types of drooling must be distinguished: anterior drooling (externalization of saliva through the lips) and posterior drooling (flow of saliva through the oropharynx that can reach the lungs by the trachea). Anterior drooling is responsible for skin erosions, fungal infections and dehydration, as well as low self-esteem and social rejection. Posterior sloughing, on the other hand, is not directly visible (unlike anterior sloughing).
Posterior bavage is not directly seen (unlike anterior bavage). However, should be noticed, as there is an increased risk of inhalation pneumonitis. Drooling is thus responsible for major social and emotional disturbances in affected children, as well as in parents/guardians/primary caregivers, justifying appropriate management. Many assessment tools are available to the clinician.
The subjective measures assess the social and emotional impact of daily life on patients and their families. For example, the Drooling Impact Scale (D.I.S.) was created by the salivary control department at Melbourne Hospital, Australia to add a subjective dimension to scales that do not assess the daily impact of drooling. There is no currently consensus method for assessing drooling importance or severity
Lot of treatment cas be proposed to patients with chornic sialorrheaalorrhea: non-drug treatments, medication (systemic or focal) and surgical treatments. Non-drug treatments consist of targeted rehabilitation by speech therapists and dental care. There is a wide range of rehabilitation techniques. However, this rehabilitation can only be effective in patients with the appropriate cognitive functions to enable them to understand and continue the exercises. Currently, there is little evidence of the effectiveness of these techniques in the scientific literature. Medication are used for their anticholinergic effect. However, due to their non-selective effect and systemic effects, medication are frequently associated with severe side-effects. These are sometimes more serious than sialorrhea, which limits the use of these molecules.
Botulinum toxin, injected specifically in the main salivary glands, has been used to treat drooling since 1997, thanks to its focal anticholinergic effect. Its efficacy has been demonstrated by randomized clinical trials: botulinum toxin has been shown to significantly reduce the frequency and severity of drooling. However, few studies have looked specifically at the efficacy of botulinum toxin in children in terms of functional and social repercussions using a subjective measurement scale.
The aim of the SIALOBOT study was to demonstrate the efficacy of botulinum toxin in the salivary glands of children with chronic sialorrhea, according to a subjective measure of daily functional impact
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- brain-injured children from 3 to 15 years of age with chronic sialorrhea.
Key inclusion criteria (5 listed)
- Brain injured children aged 3 to 15, treated in the PRM department of Besançon University Hospital between 2021 and 2025, with chronic invalidating Sialorrhea for more than three months at the time of treatment, treated with botulinum toxin injections in the salivary glands.
- Minimal weight of 12 kg,
- Stopped drooling treatments three months before injections,
- Subject (holders of parental authority) does not refuse the use of personal data
- Registration with French social security plan.
Key exclusion criteria (3 listed)
- Previous treatment with botulinum toxin in the salivary glands,
- Treatment with botulinum toxin for another indication in the previous three months,
- Contraindication to botulinum toxin injections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy of botulinum toxin in the treatment of drooling
Time frame: Five weeks
Use of the drooling impact scale to measure the efficacy of botulinum toxin on the frequency, severity and daily impact of drooling in brain injured children with chronic sialorrhea Each question is answered on a visual analogue scale (1-10) giving a score/100. 100 is the worst score (drooling had worsened).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
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Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Cerebral Palsy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drooling and Brain Injuries, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of botulinum toxin in the treatment of drooling (time frame: Five weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.