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Completed

NCT Number: NCT01737307

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

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.

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Key information

Conditions

Mucositis Digestive System Diseases Dry Mouth Gastroenteritis Gastrointestinal Diseases Infection Infections Mouth Diseases Nervous System Diseases Neurologic Manifestations Paresthesia Pathological Conditions, Signs and Symptoms Salivary Gland Diseases Sensation Disorders Signs and Symptoms Somatosensory Disorders Stomatognathic Diseases Xerostomia

Age range

12 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Azad University of Medical Sciences, Dental Branch

Tehran, Tehran Province, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoride varnish

Drug

Fluoride Varnish (NaF 5%)

Other names: Fluoride varnish(NaF 5%,Sultan,USA)

Oral hygiene

Other

Oral hygiene followed.

Other names: Twice daily (tooth brush and tooth paste).

CPP-ACP

Drug

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 outcomes

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

    Time frame: 6 weeks after first visit

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Azad University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 29, 2012
Registry last updated
Nov 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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