Effect of Fluoride Varnish and CPP-ACP on Oral and Salivary Symptoms During Chemotherapy
|ClinicalTrials.gov Identifier: NCT01737307|
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : November 29, 2012
|Condition or disease||Intervention/treatment||Phase|
|Mucositis Dry Mouth Infection||Drug: Fluoride varnish Other: Oral Hygiene Drug: CPP-ACP||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Effect of Fluoride Varnish and CPP-ACP Paste on Oral and Salivary Symptoms of Patients Under Chemotherapy: A Double-blind Clinical Trial|
|Study Start Date :||March 2011|
|Primary Completion Date :||June 2011|
|Study Completion Date :||December 2011|
Experimental: Fluoride Varnish
Fluoride varnish was used once in this group. Fluoride varnish(NaF 5%,Sultan,USA)
Drug: Fluoride varnish
Fluoride Varnish (NaF 5%)
Other Name: Fluoride varnish(NaF 5%,Sultan,USA)
Experimental: Oral hygiene
Oral hygiene followed twice daily. No F varnish or CPP-ACP applied.
Other: Oral Hygiene
Oral hygiene followed.
Other Name: Twice daily (tooth brush and tooth paste).
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.
- oral symptoms(mucositis, xerostomia, infection, dysphagia, dysgeusia, burning sensation in mouth. [ Time Frame: 6 weeks after first visit ]
- pH of saliva [ Time Frame: 6 weeks after first visit ]
- pH of dental plaque [ Time Frame: 6 weeks after first visit ]
- Quantity of saliva ( rest and stimulated) [ Time Frame: 6 weeks after first visit ]
- Saliva buffering capacity [ Time Frame: 6 weeks after first visit ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737307
|Iran, Islamic Republic of|
|Azad University of Medical Sciences, Dental Branch|
|Tehran, Iran, Islamic Republic of|
|Principal Investigator:||Sepideh Banava, Assist-Prof||Azad University of Medical Sciences, Dental Branch|