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

Primary Purpose

Mucositis, Dry Mouth, Infection

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Fluoride varnish
Oral Hygiene
CPP-ACP
Sponsored by
Azad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mucositis focused on measuring Fluoride Varnish, CPP-ACP paste, Dry mouth, Burning sensation, Chemotherapy

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Azad University of Medical Sciences, Dental Branch

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Fluoride Varnish

Oral hygiene

CPP-ACP

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

oral symptoms(mucositis, xerostomia, infection, dysphagia, dysgeusia, burning sensation in mouth.

Secondary Outcome Measures

pH of saliva
pH of dental plaque
Quantity of saliva ( rest and stimulated)
Saliva buffering capacity

Full Information

First Posted
November 15, 2012
Last Updated
November 27, 2012
Sponsor
Azad University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01737307
Brief Title
Effect of Fluoride Varnish and CPP-ACP on Oral and Salivary Symptoms During Chemotherapy
Official Title
Effect of Fluoride Varnish and CPP-ACP Paste on Oral and Salivary Symptoms of Patients Under Chemotherapy: A Double-blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azad University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis, Dry Mouth, Infection
Keywords
Fluoride Varnish, CPP-ACP paste, Dry mouth, Burning sensation, Chemotherapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluoride Varnish
Arm Type
Experimental
Arm Description
Fluoride varnish was used once in this group. Fluoride varnish(NaF 5%,Sultan,USA)
Arm Title
Oral hygiene
Arm Type
Experimental
Arm Description
Oral hygiene followed twice daily. No F varnish or CPP-ACP applied.
Arm Title
CPP-ACP
Arm Type
Experimental
Arm Description
CPP-ACP paste (GC Tooth Mousse,Gc,USA)was applied by patients once daily. 3gr,for 42 days.
Intervention Type
Drug
Intervention Name(s)
Fluoride varnish
Other Intervention Name(s)
Fluoride varnish(NaF 5%,Sultan,USA)
Intervention Description
Fluoride Varnish (NaF 5%)
Intervention Type
Other
Intervention Name(s)
Oral Hygiene
Other Intervention Name(s)
Twice daily (tooth brush and tooth paste).
Intervention Description
Oral hygiene followed.
Intervention Type
Drug
Intervention Name(s)
CPP-ACP
Other Intervention Name(s)
CPP-ACP Paste was used in this group., 3 gr , once daily , 42 days.
Intervention Description
CPP-ACP paste was applied by patient, once daily.
Primary Outcome Measure Information:
Title
oral symptoms(mucositis, xerostomia, infection, dysphagia, dysgeusia, burning sensation in mouth.
Time Frame
6 weeks after first visit
Secondary Outcome Measure Information:
Title
pH of saliva
Time Frame
6 weeks after first visit
Title
pH of dental plaque
Time Frame
6 weeks after first visit
Title
Quantity of saliva ( rest and stimulated)
Time Frame
6 weeks after first visit
Title
Saliva buffering capacity
Time Frame
6 weeks after first visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sepideh Banava, Assist-Prof
Organizational Affiliation
Azad University of Medical Sciences, Dental Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azad University of Medical Sciences, Dental Branch
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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