Effect of Fluoride Varnish and CPP-ACP Paste on Oral and Salivary Symptoms of Patients Under Chemotherapy: A Double-blind Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- oral symptoms(mucositis, xerostomia, infection, dysphagia, dysgeusia, burning sensation in mouth.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to 60 Years (Child, Adult)
- Sex
- 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
Arms & Interventions
Fluoride Varnish
Fluoride varnish was used once in this group. Fluoride varnish(NaF 5%,Sultan,USA)
Intervention: Fluoride varnish (Drug)
Oral hygiene
Oral hygiene followed twice daily. No F varnish or CPP-ACP applied.
Intervention: Oral Hygiene (Other)
CPP-ACP
CPP-ACP paste (GC Tooth Mousse,Gc,USA)was applied by patients once daily. 3gr,for 42 days.
Intervention: CPP-ACP (Drug)
Outcomes
Primary Outcomes
oral symptoms(mucositis, xerostomia, infection, dysphagia, dysgeusia, burning sensation in mouth.
Time Frame: 6 weeks after first visit
Secondary Outcomes
- 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)
Investigators
Sepideh Banava.DDS,MS
Assistant Professor Of Restorative Department
Azad University of Medical Sciences