Clinical trial · Interventional
Mouth Care Regimes During Radiotherapy
A Pilot Randomised Comparison of Bicarbonate Based Mouth Care Versus Biotene Based Mouth Care During Radiotherapy
NCT00138827CI-TRIAL-00000240completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biotene (mouth care) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Mid treatment, 2 and 6 weeks post treatment relative to baseline: Oral comfort - dichotomised as difficulty yes/no based on 3 questions
- measure
- Mucositis - dichotomised
- measure
- Xerostomia - dichotomised
- measure
- Pain medications - dichotomised
Secondary outcomes (3)
- measure
- Oral flora
- measure
- Oral pH
- measure
- Salivary flow
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.