Effect of Fluoride Varnish and CPP-ACP on Oral and Salivary Symptoms During Chemotherapy

Azad University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Infection; Dry Mouth; Mucositis

Treatments: Drug: Fluoride varnish; Drug: CPP-ACP; Other: Oral Hygiene

Study type: Interventional

Funder types: Other

Identifiers

NCT01737307

AZadUMS

Details and patient eligibility

About

The purpose of this study was to investigate the effect of Fluoride varnish and Casein Phospho-Peptide Amorphous Calcium Phosphate (CPP-ACP) containing paste on oral symptoms and salivary characteristics in patients under chemotherapy.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups

Fluoride Varnish

Experimental group

Description:

Fluoride varnish was used once in this group. Fluoride varnish(NaF 5%,Sultan,USA)

Treatment:

Drug: Fluoride varnish

Oral hygiene

Experimental group

Description:

Oral hygiene followed twice daily. No F varnish or CPP-ACP applied.

Treatment:

Other: Oral Hygiene

CPP-ACP

Experimental group

Description:

CPP-ACP paste (GC Tooth Mousse,Gc,USA)was applied by patients once daily. 3gr,for 42 days.

Treatment:

Drug: CPP-ACP