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

Infection Clinical Trial

Official title:

Effect of Fluoride Varnish and CPP-ACP Paste on Oral and Salivary Symptoms of Patients Under Chemotherapy: A Double-blind Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737307
• Other study ID #: AZadUMS
• Status: Completed
• Phase: Phase 2
• First received: November 15, 2012
• Last updated: November 27, 2012
• Start date: March 2011
• Est. completion date: December 2011

Study information

• Verified date: November 2012
• Source: Azad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dry Mouth
• Infection
• Mucositis

Intervention

Drug:
• Fluoride varnish
Fluoride Varnish (NaF 5%)

Other:
• Oral Hygiene
Oral hygiene followed.

Drug:
• CPP-ACP
CPP-ACP paste was applied by patient, once daily.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Azad University of Medical Sciences, Dental Branch	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Azad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oral symptoms(mucositis, xerostomia, infection, dysphagia, dysgeusia, burning sensation in mouth.		6 weeks after first visit	No
Secondary	pH of saliva		6 weeks after first visit	No
Secondary	pH of dental plaque		6 weeks after first visit	No
Secondary	Quantity of saliva ( rest and stimulated)		6 weeks after first visit	No
Secondary	Saliva buffering capacity		6 weeks after first visit	No