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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01737307
Other study ID # AZadUMS
Secondary ID
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


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
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