None listed
Conditions
Brief summary
There are several methods used to decrease orthodontic pain, but still today there are no versatile tools and standardized protocols. Consequently, alternatives to conventional analgesic methods are needed. This study aims to verify the analgesic effects of Auriculotherapy (AT) during the first 3 months of fixed orthodontics treatment. A population of orthodontic patients will be studied and divided in two homogeneous groups: Study Group (SG) and Control Group (CG), depending on the application / non-application of AT. Patients rated pain scores monthly on 0 to 10 visual analogue scales (VAS) at the time of bonding (t0) and subsequents two appliance adjustment (t1 and t2), relative to 6 different time moments (TM): immediately before, immediately after, after 4, 8, 24 and 72h. Descriptive statistical analysis and student’s t-test has been applied (statistical significance for p < 0.05).
Interventions
PROCESSING AND APPLICATION OF AN AURICULOTHERAPY PROTOCOL FOR THE PAIN MANAGEMENT DURING FIXED ORTHODONTIC THERAPY A consecutive series of patients, who had to undertake a fixed multibracket orthodontic therapy, will be selected in charge of the Orthodontics Service of the Department of Oral and Maxillo-Facial Sciences of the University of Rome “Sapienza”. All patients will be previously informed about the study, its aims and the potential risks, and will be given an informed consent paper. The study will carried out randomly; at the placement of the fixed orthodontic appliances, a pain assessment card will be delivered to all participants, which will be then returned to the medical staff once completed in all its parts. All participants will be asked to indicate the possible pain perception at the level of oral cavity and maxillofacial district during the initial period of orthodontic treatment, and specifically in the following three time intervals: •Start of therapy (t0): time in which the bonding of one or both dental arches is carried out •First control (t1): 1 month after t0. Time in which the orthodontic appliance is adjusted by changing the archwire at one or both dental arches •Second control (t2): 1 month after t1. Time in which the orthodontic appliance is adjusted by changing the archwire at one or both dental arches Both at the beginning of therapy, and in the following two controls (t0, t1, t2) the pain sensation will be assessed at different times: immediately before, immediately after, after 4, 8, 24 and 72 hours. The entire sample wil be divided into 2 groups, depending on the application / non-application of Auriculotherapy during the first 3 months of orthodontic treatment (t0, t1, t2): • Study Group (SG): yes Auriculotherapy • Control Group (CG): no Auriculotherapy A treatment protocol of Auriculotherapy has been developed, according to treatment methods and selection of points of TCM dictates. It involves the use of both specific pain points and of points defined as general, as related to the topographic localization of pain sensation. The protocol was elaborated and defined in collaboration with the Paracelso Institute of Rome (Moral Institution of the Ministry of Health m.d. 15 April 1996; China-Italy Center of Traditional Chinese Medicine). Selected Points: Shenmen, Subcortex, Occiput, Mouth, Large Intestine, Stomach, Lower Jaw, Upper Jaw. The treatment, at each control, will be performed on a single auricle. At the beginning of orthodontic therapy (t0) the side on which therapy is applied will be selected. The side will be based on the patient's gender, right for females and left for males. The sides to be treated will be then alternated, based on the starting one, in the following two controls (t1 and t2). The ear surface will be cleaned with a cotton wool pad soaked in ethyl alcohol and dried. Three points for pain control, “Mouth” point and the points relating to the dental arch on which the fixed orthodontic appliance was applied, will be selected. When both dental arches will be bonded at the same time, all the protocol points will be selected. Operationally, an auriculotherapy speculum will be used for the research of sensitive or reactive points, through the palpation of the ear surface. Once a reactive or sensitive area will be located, the speculum will be pressed deeper to leave a mark on the skin corresponding to the point to be treated. Immediately after, a Vaccaria seed will be applied, fixed to the skin with a plaster. This procedure will be applied for all the points to be treated. Vaccaria seeds will stay in situ for 3 days after application, then they will be removed by the patient; it will proceed to treat the other ear alternately in the subsequent controls, in the same way. The points where the seeds will be placed will be subjected to intermittent digital pressure for about 1 minute, 3 to 5 times a day. This maneuver will be taught to all participants. Patients will receive a maximum of 3 application of auriculotherapy, each lasting 3 days. Patient selection and application of the auriculotherapy will be managed by a physician with 5 years' experienced in acupuncture with the direct supervision by the other researchers.
Sponsors
Study design
Eligibility
Inclusion criteria
- patients with malocclusion (I, II or III class) - patients that will have to undertake a fixed multibracket orthodontic therapy at lower, upper, or both dental arches
Exclusion criteria
Patients with intellectual disabilities, chronic and / or metabolic diseases, those taking analgesic drug therapy, and patients already undergoing orthodontic treatment or who have already done one previously,