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

Study Overview
=================
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.

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

Conditions
-----------------
Mucositis, Dry Mouth, Infection

Intervention / Treatment
-----------------
* Drug: Fluoride varnish
* Other: Oral Hygiene
* Drug: CPP-ACP


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluoride Varnish<br>Fluoride varnish was used once in this group. Fluoride varnish(NaF 5%,Sultan,USA) | Drug: Fluoride varnish<br>* Fluoride Varnish (NaF 5%)<br>* Other names: Fluoride varnish(NaF 5%,Sultan,USA);|
| Experimental: Oral hygiene<br>Oral hygiene followed twice daily. No F varnish or CPP-ACP applied. | Other: Oral Hygiene<br>* Oral hygiene followed.<br>* Other names: Twice daily (tooth brush and tooth paste).;|
| Experimental: CPP-ACP<br>CPP-ACP paste (GC Tooth Mousse,Gc,USA)was applied by patients once daily. 3gr,for 42 days. | Drug: CPP-ACP<br>* CPP-ACP paste was applied by patient, once daily.<br>* Other names: 3 gr , once daily , 42 days.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral symptoms(mucositis, xerostomia, infection, dysphagia, dysgeusia, burning sensation in mouth. |  | 6 weeks after first visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry mouth, Fluoride Varnish, CPP-ACP paste, Burning sensation, Chemotherapy