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Trial registered on ANZCTR


Registration number
ACTRN12618001258246p
Ethics application status
Submitted, not yet approved
Date submitted
26/06/2018
Date registered
25/07/2018
Date last updated
25/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Auriculotherapy protocol used to manage orthodontic pain
Scientific title
Auriculotherapy protocol used to evaluate and manage orthodontic pain: comparative assessment of pain management in the first 3 months of fixed orthodontic treatment
Secondary ID [1] 295324 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
orthodontic pain 308519 0
Condition category
Condition code
Alternative and Complementary Medicine 307489 307489 0 0
Other alternative and complementary medicine
Anaesthesiology 307490 307490 0 0
Pain management
Oral and Gastrointestinal 307819 307819 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.


Intervention code [1] 301648 0
Treatment: Devices
Intervention code [2] 301649 0
Treatment: Other
Comparator / control treatment
The Control Group consists of randomly selected patients, in charge of the Orthodontic Service of the Univeristy of Rome “Sapienza”.
They have NOT undergone auriculotherapy treatment, but they wiill still be subjected to the normal fixed orthodontic therapy and, They will fill in the the pain assessment card with the same times and modalities of the study group.
Control group
Active

Outcomes
Primary outcome [1] 306463 0
Evaluation of orthodontic pain charateristics during the first 3 months of fixed orthodontic therapy.
Assessment of pain management skills by auriculotherapy.
As a tool of pain self-assessment will be used the VAS scale (Visual Analogue Scale), represented as a straight line of 10 cm between two extremes: "no pain" (0) and "maximum pain" (10). Patient's algic sensations will be arbitrarily divided into five categories, based on the value given in terms of VAS scale: no pain (0), mild (1-3); medium (3-5); severe (5-7); very severe (> 7).
Both at the beginning of therapy, and in the following two controls (t0, t1 and t2), the VAS scale will be used to quantify the pain sensation at different times: immediately before, immediately after, after 4, 8, 24 and 72 hours.
Timepoint [1] 306463 0
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
So primary outcomes will be assesses at 1 month and 2 months after auricolotherapy commencement.
Secondary outcome [1] 348623 0
As a tool of pain self-assessment will be used the VAS scale (Visual Analogue Scale), represented as a straight line of 10 cm between two extremes: "no pain" (0) and "maximum pain" (10). Patient's algic sensations will be arbitrarily divided into five categories, based on the value given in terms of VAS scale: no pain (0), mild (1-3); medium (3-5); severe (5-7); very severe (> 7).
Timepoint [1] 348623 0
at 3 months after appliance application

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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,

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/09/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 10586 0
Italy
State/province [1] 10586 0
Rome

Funding & Sponsors
Funding source category [1] 299913 0
University
Name [1] 299913 0
Sapienza University of Rome
Country [1] 299913 0
Italy
Primary sponsor type
University
Name
Sapienza University of Rome
Address
Via Caserta 6, 00161 Rome
Country
Italy
Secondary sponsor category [1] 299281 0
Charities/Societies/Foundations
Name [1] 299281 0
Paracelsus Institute
Address [1] 299281 0
Via Ippolito Nievo 61, 00153 Rome
Country [1] 299281 0
Italy

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300783 0
SAPIENZA UNIVERSITY OF ROME
Ethics committee address [1] 300783 0
Ethics committee country [1] 300783 0
Italy
Date submitted for ethics approval [1] 300783 0
22/05/2018
Approval date [1] 300783 0
Ethics approval number [1] 300783 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84806 0
Prof Gabriella Galluccio
Address 84806 0
Sapienza University- via caserta 6, 00161 Rome
Country 84806 0
Italy
Phone 84806 0
+39 06 49976641
Fax 84806 0
Email 84806 0
[email protected]
Contact person for public queries
Name 84807 0
Gabriella Galluccio
Address 84807 0
Sapienza University - via caserta 6, 00161 Rome
Country 84807 0
Italy
Phone 84807 0
+39 06 49976641
Fax 84807 0
Email 84807 0
[email protected]
Contact person for scientific queries
Name 84808 0
Emanuela Serritella
Address 84808 0
Sapienza University - via caserta 6, 00161 Rome
Country 84808 0
Italy
Phone 84808 0
+39 0683603088
Fax 84808 0
Email 84808 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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