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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sepideh Banava.DDS,MS, Azad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01737307
First received: November 15, 2012
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Mucositis
Dry Mouth
Infection
 Drug: Fluoride varnish
Other: Oral Hygiene
Drug: CPP-ACP
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Azad University of Medical Sciences:

Primary Outcome Measures:
  • oral symptoms(mucositis, xerostomia, infection, dysphagia, dysgeusia, burning sensation in mouth. [ Time Frame: 6 weeks after first visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pH of saliva [ Time Frame: 6 weeks after first visit ] [ Designated as safety issue: No ]
  • pH of dental plaque [ Time Frame: 6 weeks after first visit ] [ Designated as safety issue: No ]
  • Quantity of saliva ( rest and stimulated) [ Time Frame: 6 weeks after first visit ] [ Designated as safety issue: No ]
  • Saliva buffering capacity [ Time Frame: 6 weeks after first visit ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: March 2011
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737307

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

No publications provided

Responsible Party: Sepideh Banava.DDS,MS, Assistant Professor Of Restorative Department, Azad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01737307     History of Changes
Other Study ID Numbers: AZadUMS
Study First Received: November 15, 2012
Last Updated: November 27, 2012
Health Authority: Iran: Ethics Committee

Keywords provided by Azad University of Medical Sciences:
Fluoride Varnish
CPP-ACP paste
Dry mouth
Burning sensation
Chemotherapy

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

ClinicalTrials.gov processed this record on May 19, 2013