Recruitment of general resin clinical trial subjects
Department of dental and pulp diseases, Stomatological Hospital of the Fourth Military Medical University
One
About us
A general resin clinical trial is being carried out in the Department of dental pulp disease, Stomatological Hospital of the Fourth Military Medical University.
The clinical trial is a multicenter clinical trial, which was carried out in three hospitals in China, the Stomatological Hospital of the Fourth Military Medical University, the West China Stomatological Hospital of Sichuan University and the Stomatological Hospital Affiliated to Nanjing Medical University.
This clinical trial has passed the examination of the ethics committee of our hospital (approval No.: irb-rev-2018029), and now subjects are recruited for the society.
Two
Product introduction
The general resin is mainly composed of resin matrix and inorganic filler, which is a light curing composite resin. It has successfully passed the safety test of the equipment quality inspection center of the State Food and drug administration, and all performances meet the requirements.
Three
Inclusion Criteria
1. 18-70 years old, gender unlimited, opening degree normal;
2. Good health, no major systemic diseases such as malignant tumors, cardiovascular and cerebrovascular diseases;
3. The degree of lesion reached to the hard tissue defect in the middle layer of dentin, and the pulp vitality was normal, which should meet the following requirements:
(a) Tooth position: all teeth;
(b) Hole type: class I hole;
(c) No special staining was found on teeth, such as tetracycline;
(d) The color of teeth is similar to that of A2 / A3 general resin.
4. The opposite teeth are natural teeth and the occlusion relationship is normal;
5. If the subject is a woman of childbearing age, pregnancy test should be carried out and the result is negative;
6. Patients who agree to use the device for treatment and sign the written informed consent;
7. Patients who are willing and able to follow up in time according to the requirements of the program.
Four
Exclusion criteria
Subjects who have any of the following conditions shall not be included in the group:
Allergic constitution or multi drug allergy; hypersensitivity history of polymer based materials such as dental resin;
Keywords severe periodontitis; poor oral health; salivary gland dysfunction; TMJ disorder;
The patients with non carious teeth, such as the teeth with pathological wear (night molars, clenching habits), acidosis or cryptocleft, etc;
DMFT ≥ 3;
Abnormal occlusion, such as deep occlusion;
Patients with major systemic diseases such as malignant tumors, cardiovascular and cerebrovascular diseases, pregnant and pregnant women of childbearing age and lactating age with intention of pregnancy within one year, patients with mental diseases;
Subjects considered unsuitable by the researchers, such as poor compliance, etc;
There is a plan to go abroad within one year, or there are other reasons that can not complete the follow-up for one year;
Subjects took part in clinical trials of other drugs or devices at the same time and failed to reach the end point; subjects took part in other clinical trials in the past 3 months;
Cannot tolerate or use rubber barrier;
Who is undergoing orthodontic treatment.
Five
Subjects need to cooperate
It is necessary to come to the hospital for screening examination, repair operation, one week after filling and one year back to the hospital for reexamination;
Inspection to be coordinated:
Screening examination: oral examination, X-ray, etc
One week after operation, oral examination, X-ray, etc
One year after operation, oral examination, X-ray, etc
Note: urine tests are required for women of childbearing age.
Six
Rights and interests of subjects
The cost of general resin provided by NANOVA biomaterials, lnc. And related inspection and treatment shall be borne by the sponsor;
For the time and transportation cost you spent in the follow-up of this study, we will give you a certain amount of subsidy, such as traffic delay, with a total amount of 800 yuan, which will be paid to you by the research doctor after you complete all the follow-up.
Seven
contact us
Hospital Name: Stomatological Hospital of the Fourth Military Medical University
Hospital address: No.145, Changle West Road, Xi'an
Contact: Yang Sha
Tel: 18802933418
Eight
Enrollment link