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Mouth Care Regimes During Radiotherapy

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ClinicalTrials.gov Identifier: NCT00138827
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : December 15, 2005
Information provided by:
St George Hospital, Australia

August 29, 2005
August 30, 2005
December 15, 2005
November 1999
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  • 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
  • Mid treatment, 2 & 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
Complete list of historical versions of study NCT00138827 on ClinicalTrials.gov Archive Site
  • Oral flora
  • Oral pH
  • Salivary flow
Same as current
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Mouth Care Regimes During Radiotherapy
A Pilot Randomised Comparison of Bicarbonate Based Mouth Care Versus Biotene Based Mouth Care During Radiotherapy
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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Head and Neck Neoplasms
Drug: Biotene (mouth care)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 2003
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
99/65 Graham
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St George Hospital, Australia
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Principal Investigator: Associate Professor Peter H Graham St George Hospital, Sydney, Australia
St George Hospital, Australia
May 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP