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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01737307
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : November 29, 2012
Information provided by (Responsible Party):
Sepideh Banava.DDS,MS, Azad University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Mucositis Dry Mouth Infection Drug: Fluoride varnish Other: Oral Hygiene Drug: CPP-ACP Phase 2

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : March 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: 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.
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.

Primary Outcome Measures :
  1. oral symptoms(mucositis, xerostomia, infection, dysphagia, dysgeusia, burning sensation in mouth. [ Time Frame: 6 weeks after first visit ]

Secondary Outcome Measures :
  1. pH of saliva [ Time Frame: 6 weeks after first visit ]
  2. pH of dental plaque [ Time Frame: 6 weeks after first visit ]
  3. Quantity of saliva ( rest and stimulated) [ Time Frame: 6 weeks after first visit ]
  4. Saliva buffering capacity [ Time Frame: 6 weeks after first visit ]

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01737307

Iran, Islamic Republic of
Azad University of Medical Sciences, Dental Branch
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Azad University of Medical Sciences
Principal Investigator: Sepideh Banava, Assist-Prof Azad University of Medical Sciences, Dental Branch

Responsible Party: Sepideh Banava.DDS,MS, Assistant Professor Of Restorative Department, Azad University of Medical Sciences Identifier: NCT01737307     History of Changes
Other Study ID Numbers: AZadUMS
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: November 29, 2012
Last Verified: November 2012

Keywords provided by Sepideh Banava.DDS,MS, Azad University of Medical Sciences:
Fluoride Varnish
CPP-ACP paste
Dry mouth
Burning sensation

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs