Skip to content

Mouth Care Regimes During Radiotherapy

A Pilot Randomised Comparison of Bicarbonate Based Mouth Care Versus Biotene Based Mouth Care During Radiotherapy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00138827
Enrollment
50
Registered
2005-08-30
Start date
1999-11-30
Completion date
2003-03-31
Last updated
2005-12-15

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

Conditions

Head and Neck Neoplasms

Keywords

Radiotherapy, Mucositis, Xerostomia

Brief summary

The purpose of this study is to assess whether Biotene oral care products have a benefit in the treatment of xerostomia and mucositis when compared with conventional bicarbonate mouth care regimes.

Detailed description

Grade III and IV mucositis occurs in 30-60% of patients undergoing head and neck irradiation. Where mucositis is severe a patient's ability to swallow may become significantly compromised and nutritional requirements may not be met. Xerostomia is often an early side effect of treatment. As salivary tissue is very sensitive to radiation there is often a change in saliva early in the treatment. New products on the market have claimed to alleviate the symptoms of dry mouth and to help the body's natural defenses reduce the harmful oral bacteria. These products contain the important salivary enzymes lactoperoxidase, lysozyme, lactoferrin and glucose oxidase. Biotene products therefore have the potential to reduce microbial populations which result in radiation caries and periodontal disease and in addition provide relief from the discomfort of xerostomia. Despite the knowledge surrounding xerostomia in the head and neck irradiation population, its treatment has not been well documented and the question of patient comfort is not well addressed. Comparisons: This study aims to compare the different mouth care regimes and determine the most effective treatment alternatives during radiotherapy. Patients will be randomised to either Biotene or Bicarbonate-based mouth care regimes. Patients will be stratified according to whether they are receiving radiotherapy alone or chemo irradiation to ensure equal distribution across the different mouth care regimes.

Interventions

DRUGBiotene (mouth care)

Sponsors

St George Hospital, Australia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Are undergoing oral or pharyngeal irradiation with a cumulative dose \> 35Gy with at least 1/2 of the salivary tissue contained within the field of treatment. * May or may not have undergone surgery. * Are available for follow-up questionnaires. * Are English speaking or have an easily accessible interpreter.

Exclusion criteria

* No co-morbidities which may result in dry mouth, for example Sjögren syndrome.

Design outcomes

Primary

MeasureTime frame
Mid treatment, 2 and 6 weeks post treatment relative to baseline: Oral comfort - dichotomised as difficulty yes/no based on 3 questions
Mucositis - dichotomised
Xerostomia - dichotomised
Pain medications - dichotomised

Secondary

MeasureTime frame
Oral pH
Salivary flow
Oral flora

Countries

Australia

Outcome results

None listed

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