CE Yellow 5% Fluoride Varnish For Dental Cavity With Melon Tasety
Research Design
This study is a randomized, controlled, single-blind, single-arm, interventional clinical study.
Randomization: This study uses SPSS to generate random numbers by a person who does not have contact with the patients before the experiment, and the patients are grouped according to the generated numbers.
Experimental grouping: Thisstudy is divided into 2 groups. In experimental group 1,materials with a fluoride content of 2 2600 ppm are used for tooth surface treatment before radiotherapy. 2 2600 ppm materials were treated with tooth surface treatment once; experimental group and control group were not treated with tooth surface treatment with materials with fluoride content of 2 2600 ppm ; before radiotherapy and at 1, 3, 6, 9, and 12 months after radiotherapy , The OHIP-14 scale was used to collect the oral problems of the patients. At the same time, the oral health education was conducted by the stomatologist to observe the oral cavity of the patients, and to collect the other oral damages of the patients.
Product Information:
| Name | Fluoride Varnish |
| Package | 10g |
| Tasty | Melon |
| Origional Place | Chengdu, China |
| Approved | CE and ISO |
Single-blind
The randomization of this study was performed by a person who did not have
contact with the patients, and the patients did not know in advance which group they would be
entering .
Study sample size assessment:
According to previous studies, the sample was calculated by the method of comparing the
difference of the means of the two groups, and it is estimated that 25 patients will be needed .
patient oral care interventions
The experimental group wastreated with materials with a fluoride content of 2 2600 ppm every
three months before radiotherapy and every three months after radiotherapy . At the same time, the
oral health education related to radiotherapy was given by the dentist . 2 2600 ppm material for tooth
surface treatment; health education only .
Statistical Analysis
The following data will be obtained from our trial: basic information about the patient, a
scale filled out by the patient, and the dentist's assessment of the degree of oral damage caused by
the patient 'sradiation therapy.
Basic information: Subjects were checked for demographic bias using T- test for patient age,
sex,stage,radiation dose, etc.
Company Profiles:
Chengdu I-ReHealth Medical Devices Co., Ltd is a high-tech R&D and manufacturing company focusing on the oral health field (medical materials and medical devices). Founded in 2016, it is located in the beautiful "Tianfu Kingdom"-Chengdu.
Based on the dental industry, I-ReHealth develops a strategic layout and is committed to providing customers with high-quality oral medical solutions. The company has formed a long-term and in-depth cooperation relationship with the West China Hospital of Stomatology.
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