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

Phase 2

Completed

• Conditions: Mucositis; Dry Mouth; Infection
• Interventions: Drug: Fluoride varnish; Other: Oral Hygiene; Drug: CPP-ACP

• Registration Number: NCT01737307
• Lead Sponsor: Azad University of Medical Sciences

Brief Summary

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.

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 Timeline

• Study Start: 2011-03
• Primary Completion: 2011-06
• Study Completion: 2011-12
• Status Verified: 2012-11
• Study First Submitted: 2012-11-15
• Study First Submitted QC: 2012-11-27
• Last Update Submitted: 2012-11-27
• Study First Posted: 2012-11-29
• Last Update Posted: 2012-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoride Varnish	Fluoride varnish	Fluoride varnish was used once in this group. Fluoride varnish(NaF 5%,Sultan,USA)
Oral hygiene	Oral Hygiene	Oral hygiene followed twice daily. No F varnish or CPP-ACP applied.
CPP-ACP	CPP-ACP	CPP-ACP paste (GC Tooth Mousse,Gc,USA)was applied by patients once daily. 3gr,for 42 days.

Primary Outcome Measures

Name	Time	Method
oral symptoms(mucositis, xerostomia, infection, dysphagia, dysgeusia, burning sensation in mouth.	6 weeks after first visit

Secondary Outcome Measures

Name	Time	Method
pH of saliva	6 weeks after first visit
pH of dental plaque	6 weeks after first visit
Quantity of saliva ( rest and stimulated)	6 weeks after first visit
Saliva buffering capacity	6 weeks after first visit

Trial Locations

Locations (1)

Azad University of Medical Sciences, Dental Branch; 🇮🇷 Tehran, Iran, Islamic Republic of