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

November 27, 2012 updated by: Sepideh Banava.DDS,MS, Azad University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluoride Varnish
Fluoride varnish was used once in this group. Fluoride varnish(NaF 5%,Sultan,USA)
Drug: Fluoride varnish
Fluoride Varnish (NaF 5%)
Other Names:
  • Fluoride varnish(NaF 5%,Sultan,USA)
Experimental: Oral hygiene
Oral hygiene followed twice daily. No F varnish or CPP-ACP applied.
Other: Oral Hygiene
Oral hygiene followed.
Other Names:
  • Twice daily (tooth brush and tooth paste).
Experimental: CPP-ACP
CPP-ACP paste (GC Tooth Mousse,Gc,USA)was applied by patients once daily. 3gr,for 42 days.
Drug: CPP-ACP
CPP-ACP paste was applied by patient, once daily.
Other Names:
  • CPP-ACP Paste was used in this group.
  • 3 gr , once daily , 42 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
oral symptoms(mucositis, xerostomia, infection, dysphagia, dysgeusia, burning sensation in mouth.
Time Frame: 6 weeks after first visit
6 weeks after first visit

Secondary Outcome Measures

Outcome Measure
Time Frame
pH of saliva
Time Frame: 6 weeks after first visit
6 weeks after first visit
pH of dental plaque
Time Frame: 6 weeks after first visit
6 weeks after first visit
Quantity of saliva ( rest and stimulated)
Time Frame: 6 weeks after first visit
6 weeks after first visit
Saliva buffering capacity
Time Frame: 6 weeks after first visit
6 weeks after first visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azad University of Medical Sciences

Investigators

  • Principal Investigator: Sepideh Banava, Assist-Prof, Azad University of Medical Sciences, Dental Branch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

November 15, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (Estimate)

November 29, 2012

Study Record Updates

Last Update Posted (Estimate)

November 29, 2012

Last Update Submitted That Met QC Criteria

November 27, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZadUMS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mucositis

Clinical Trials on Fluoride varnish

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe