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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01737307

Enrollment

Registered

2012-11-29

Start date

2011-03-31

Completion date

2011-12-31

Last updated

2012-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucositis, Dry Mouth, Infection

Keywords

Fluoride Varnish, CPP-ACP paste, Dry mouth, Burning sensation, Chemotherapy

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.

Interventions

DRUGFluoride varnish

Fluoride Varnish (NaF 5%)

OTHEROral Hygiene

Oral hygiene followed.

DRUGCPP-ACP

CPP-ACP paste was applied by patient, once daily.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 60 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026