Orthodontic adjuvant therapy
Conditions
Interventions
Treatment group:orthodontics + experimental medical device
Control group:orthodontics + sham experimental medical device treatment
Sponsors
West China Hospital of Stomatology, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients to be treated with invisible dental orthodontics, regardless of gender; 2. There is no age limit, but the dental morphology needs to meet the following two points: (1) Permanent dentition, dental arch is basically symmetrical; (2) The dental crown morphology is normal or the dental crown has been repaired. 3. The subject or his guardian can fully understand the therapy and is willing to cooperate to complete the follow-up requirements; 4. Minors under the age of 18 years old as subjects shall obtain the informed consent of their guardians, who shall sign the informed consent form. If the minor can express his intention whether to participate in the trial, its also necessary to obtain his own consent and let him to sign the informed consent form at the same time. Adults as subjects should sign their own informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with severe jaw opening who are not suitable for invisible dental orthodontics, according to the researcher's judgment; 2.Patients with serious periodontal disease which is failed to control, as well as patients prone to caries; 3.Patients with oral or maxillofacial tumors, or those who have received radiotherapy for the jaw bone; 4.Patients with severe unilateral mastication; 5.Patients who was treated with drugs that may affect or promote bone metabolism in the past six months or patients who will be treated with drugs that may affect or promote bone metabolism during the trial period; 6.Patients with history of photosensitive reaction; 7.Those who have participated in other clinical trials within 30 days; 8.Those who are unable to cooperate or unwilling to cooperate due to neurological or mental diseases; 9.An electronic implant has been or needs to be used in the body, and the operation of the implant will be affected by the experimental device; 10.Lactating or pregnant women and those who have pregnancy plans in the next 90 days; 11.Those who are not suitable to participate in this clinical trial, according to the researcher's judgment.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Average orthodontic efficiency of all types of tooth movement;Orthodontic efficiency of different types of teeth;NRS scores; | — |
Primary
| Measure | Time frame |
|---|---|
| Average orthodontic efficiency of anterior teeth intrusion; | — |
Countries
China
Contacts
Public ContactLiu Xian
West China Hospital of Stomatology
Outcome results
None listed