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

NCT ID: NCT01737307

Last Updated: 2012-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Mucositis Dry Mouth Infection

Keywords

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Fluoride Varnish CPP-ACP paste Dry mouth Burning sensation Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Fluoride Varnish

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

Group Type EXPERIMENTAL

Fluoride varnish

Intervention Type DRUG

Fluoride Varnish (NaF 5%)

Oral hygiene

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

Group Type EXPERIMENTAL

Oral Hygiene

Intervention Type OTHER

Oral hygiene followed.

CPP-ACP

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

Group Type EXPERIMENTAL

CPP-ACP

Intervention Type DRUG

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

Interventions

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Fluoride varnish

Fluoride Varnish (NaF 5%)

Intervention Type DRUG

Oral Hygiene

Oral hygiene followed.

Intervention Type OTHER

CPP-ACP

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

Intervention Type DRUG

Other Intervention Names

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Fluoride varnish(NaF 5%,Sultan,USA) Twice daily (tooth brush and tooth paste). CPP-ACP Paste was used in this group. 3 gr , once daily , 42 days.

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Sepideh Banava.DDS,MS

Assistant Professor Of Restorative Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sepideh Banava, Assist-Prof

Role: PRINCIPAL_INVESTIGATOR

Azad University of Medical Sciences, Dental Branch

Locations

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Azad University of Medical Sciences, Dental Branch

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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AZadUMS

Identifier Type: -

Identifier Source: org_study_id