- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01737307
Effect of Fluoride Varnish and CPP-ACP on Oral and Salivary Symptoms During Chemotherapy
Effect of Fluoride Varnish and CPP-ACP Paste on Oral and Salivary Symptoms of Patients Under Chemotherapy: A Double-blind Clinical Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Chemotherapy as a treatment method of cancers, affects different parts of the oral cavity such as oral mucosa, teeth and salivary glands caused by salivary glands dysfunction during chemotherapy.Oral status of patients under chemotherapy will be affected by consumption of the drugs and their side effects such as reduction of the saliva, dryness of the oral cavity, changes in bacterial balance, oral mucosa damage, bleeding due to irritation of the tissues, xerostomia, dental caries, burning sensation, dysgeusia and dysphagia. No effective preventive protocol has been presented for oral care during chemotherapy.
Patients who were met the inclusion criteria (aged over 12, diagnosed to have cancer by an oncologists and needed chemotherapy drugs, had at least 20 teeth, had no other pathologic lesion in their oral cavity, were not treated by radiotherapy and did not have specific systemic diseases or head and neck cancer) were selected for the study. the participants were evaluated according to oral and salivary symptoms.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Azad University of Medical Sciences, Dental Branch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- to have cancer (in the first stage of their treatments)
- to have at least 20 teeth,
- age over 12
Exclusion Criteria:
- to have pathologic lesion in the oral cavity
- being under radiotherapy
- to have specific systemic diseases
- to have head and neck cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fluoride Varnish
Fluoride varnish was used once in this group.
Fluoride varnish(NaF 5%,Sultan,USA)
|
Fluoride Varnish (NaF 5%)
Other Names:
|
Experimental: Oral hygiene
Oral hygiene followed twice daily.
No F varnish or CPP-ACP applied.
|
Oral hygiene followed.
Other Names:
|
Experimental: CPP-ACP
CPP-ACP paste (GC Tooth Mousse,Gc,USA)was applied by patients once daily.
3gr,for 42 days.
|
CPP-ACP paste was applied by patient, once daily.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
oral symptoms(mucositis, xerostomia, infection, dysphagia, dysgeusia, burning sensation in mouth.
Time Frame: 6 weeks after first visit
|
6 weeks after first visit
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pH of saliva
Time Frame: 6 weeks after first visit
|
6 weeks after first visit
|
pH of dental plaque
Time Frame: 6 weeks after first visit
|
6 weeks after first visit
|
Quantity of saliva ( rest and stimulated)
Time Frame: 6 weeks after first visit
|
6 weeks after first visit
|
Saliva buffering capacity
Time Frame: 6 weeks after first visit
|
6 weeks after first visit
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sepideh Banava, Assist-Prof, Azad University of Medical Sciences, Dental Branch
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AZadUMS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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