Oral Mucositis Due to Radiation
Conditions
Keywords
vitamin D topical oral gel
Brief summary
The main aim of this study was to evaluate clinically the effect of topical oral vitamin D gel in comparison to conventional therapy in prevention of radiation - induced oral mucositis
Detailed description
The study was designed as randomized, controlled, clinical trial. patients who were undergoing to receive radiotherapy were divided into three groups: Group I: was given conventional treatment.Group II : was given topical oral gel of vitamin D. Group III: was given topical oral gel of vitamin D in combination with the conventional treatment. All patients were clinically evaluated at the start the radiotherapy, three weeks and six weeks later for pain and oral mucositis severity.
Interventions
DRUGvitamin D oral gel
vitamin D is a fat soluble vitamin which has important calcemic roles in the body regarding bone homeostasis and calcium/phosphorus balance. Recently, the non-calcemic roles of vitamin D as anti-inflammatory, anti-oxidant and immuno-regulatory functions have been widely reported.So, we tried to use it for prevention of radiation induced oral mucositis
topical anti fungal agent
DRUGBBC oral spray
Topical anesthetics and anti-inflammatory agent
DRUGOracure gel
Topical analgesic gel
OTHERAlkamisr sachets
Sodium bicarbonate mouthwash
Sponsors
Hams Hamed Abdelrahman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy. * Patients whose radiotherapy treatment planned dose is 50 Gy or above. * Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy.
Exclusion criteria
* Patients under Anticoagulants such as warfarin, heparin, or aspirin. * Patients whose radiotherapy treatment planned dose is lower than 50 Gy. * Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction) * Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure. * Hyper-calcemic patients. * Smokers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in severity of oral mucositis at different time points along the study | up to 3 and 6 weeks | Oral mucositis will be evaluated by the World Health Organization (WHO) scale which record the extent and severity of oral mucositis at the third and sixth week after the first radiotherapy session. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain and discomfort severity at different time points along the study: Numeric Rating Scale | up to 3 and 6 weeks | Discomfort and pain severity were reported by each patient using Numeric Rating Scale (NRS) at the third and sixth week after the first radiotherapy session. |
Countries
Egypt
Contacts
Primary ContactIslam s Bakr, BDS
Outcome results
None listed