The use of ChloroStay mouthwash for better dental care during brace treatment

ISRCTN	ISRCTN14397728
DOI	https://doi.org/10.1186/ISRCTN14397728
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	365255
Protocol serial number	Nil known
Sponsor	Queen Mary University of London
Funder	Schottlander and Davis Ltd

Submission date: 22/10/2025
Registration date: 31/10/2025
Last edited: 29/10/2025

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Children who wear fixed braces often find it difficult to clean their teeth properly, which can lead to problems with their teeth and gums. This study is looking at whether using a special mouthwash called ChloroStay™ can help improve dental care for children while they are having brace treatment.

Who can participate?
Children (12 -1 6 years) who are receiving routine hospital-based treatment with fixed braces may be invited to take part in the study.

What does the study involve?
All children in the study will continue brushing their teeth and gums with their usual toothbrush and toothpaste. Half of the children will also be asked to use the ChloroStay™ mouthwash as part of their daily routine. The study will follow their progress throughout their brace treatment.

What are the possible benefits and risks of participating?
Using the mouthwash may help improve the health of children's teeth and gums during brace treatment. There are no known serious risks, but as with any dental product, some children may experience mild side effects like irritation or dislike the taste.

Where is the study run from?
Queen Mary University of London (UK)

When is the study starting and how long is it expected to run for?
October 2025 to October 2028

Who is funding the study?
Schottlander and Davis Ltd, the company that developed the ChloroStay™ mouthwash.

Who is the main contact?
Professor Ama Johal, a.s.johal@qmul.ac.uk

Contact information

Prof Ama Johal
Public, Scientific, Principal investigator

Turner Street
Whitechapel
London
E1 2AD
United Kingdom

ORCID ID	0000-0001-6841-227X
Phone	+44 2078828631
Email	a.s.johal@qmul.ac.uk

Study information

Primary study design	Interventional
Study design	Single-centre hospital-based randomized controlled clinical trial with parallel design
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	The effectiveness of ChloroStay mouthwash in optimising dental and gingival health during orthodontic treatment: a randomized controlled trial
Study objectives	The aim of the trial is to assess the ability of a Chlorhexidine mouthwash [ChloroStay™] to help maintain optimal dental and gum care during routine orthodontic treatment.
Ethics approval(s)	Not yet submitted, Ethics committee name not provided (Address not provided, City not provided, Zip/postal code not provided; Telephone number not provided; Email not provided), ref: Reference number not provided
Health condition(s) or problem(s) studied	Optimal dental and gum care during routine orthodontic treatment
Intervention	Participants will be randomly assigned to intervention care [IC] and standardised care [SC] and assessed at baseline, 1-, 6- and 12-months, with the final scoring being at the removal of fixed braces [debond appointment]. Each participant will be instructed to maintain the recommended oral care for fixed appliance treatment, in which they are advised to clean their teeth using their regular toothbrush, an interdental brush and toothpaste twice daily [Standardized care Group]. Participants in the IC group will be issued with 3-month supply of ChloroStay Seven Day Mouthwash, along with the recommended instructions on use . Participants will be randomised to receive either the ChloroStay Seven Day Mouthwash [Intervention care group] or standard oral care, as provided routinely to all participants undergoing fixed appliance treatment. Randomisation will be performed centrally, using a computer-generated randomisation sequence, by placing the randomisation sequences in opaque envelopes to ensure allocation concealment. Each participant will be anonymised and both the operator and participant blinded to treatment assignment
Intervention type	Supplement
Primary outcome measure(s)	1. Age is measured using demographic questionnaire at baseline 2. Gender is measured using demographic questionnaire at baseline 3. Ethnicity is measured using demographic questionnaire at baseline 4. Visible plaque is measured using the Turesky modification of the Quigley–Hein plaque index at baseline, 1 month, 6 months, 12 months and debond 5. Gingival health is measured using the Loe and Silness gingival index at baseline, 1 month, 6 months, 12 months and debond 6. Intra-oral condition is measured using high-quality intra-oral photographs at baseline and debond 7. Supragingival plaque is measured using plaque sampling at baseline, 1 month, 6 months and 12 months 8. Alpha diversity of oral microbiome is measured using 16S rRNA gene amplicon sequencing at baseline, 1 month, 6 months and 12 months 9. Beta diversity of oral microbiome is measured using 16S rRNA gene amplicon sequencing at baseline, 1 month, 6 months and 12 months 10. Differential abundance of oral taxa is measured using 16S rRNA gene amplicon sequencing at baseline, 1 month, 6 months and 12 months 11. Functional acidogenicity is measured using standardised glucose challenge with pH recording at 0, 5, 10, 15 and 20 minutes at baseline, 1 month, 6 months and 12 months 12. Resting salivary pH is measured using titration or validated chairside kit score at baseline, 1 month, 6 months and 12 months 13. Salivary buffering capacity is measured using titration or validated chairside kit score at baseline, 1 month, 6 months and 12 months 14. Site-specific acidogenicity effects are measured using three-level mixed models at baseline, 1 month, 6 months and 12 months
Key secondary outcome measure(s)	There are no secondary outcome measures
Completion date	17/10/2028

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	12 Years
Upper age limit	16 Years
Sex	All
Target sample size at registration	52
Total final enrolment	52
Key inclusion criteria	1. Adolescents [12-16 years] of all ethnicity, socio-economic grouping and gender, for whom parents are able and willing to give informed consent 2. Planned to undergone a minimum of 12-months of fixed appliance treatment in both arches 3. Optimal dental health and oral hygiene prior to treatment
Key exclusion criteria	1. Participants who have undergone previous course of fixed appliance treatment 2. Pre-existing clinical evidence of either enamel structural defects, demineralised lesions or fluorosis prior to commencement of treatment 3. Unwilling or unable to give consent 4. Inability to understand written and/or verbal English 5. Vulnerable individuals 6. Participation in other studies
Date of first enrolment	01/03/2026
Date of final enrolment	01/03/2027

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Barts Health NHS Trust

The Royal London Hospital
80 Newark Street
London
E1 2ES
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from [Professor Ama Johal ; email: a.s.johal@qmul.ac.uk] in a fully anonymised format, for a period of up to 3-years from completion of the study.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

27/10/2025: Trial's existence confirmed by QMUL.