Clinical trial NCT04834466: Factors Associated With Pain Level Experience in Orthodontic Treatment
Official title: Factors Associated With Pain Level Experience in Orthodontic Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Orthodontic Pain
Pain
Orthodontic Appliance Complication
Lead sponsor: Alfonso X El Sabio University
Sponsor class: OTHER
Collaborators: name: Shen Gaang Jong Shiaw Hospital
First posted: 2021-04-08
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from Clinic Centro Odontologo Innovaccion y especialidad avanzadas who are undergoing orthodontic treatment were selected.

Brief summary: Orthodontic pain has been the primary concern from all patients who requires orthodontic treatment. The design of the study will help us comprehend how patient experienced and managed pain during their orthodontic treatment, average pain level in different orthodontic appliances and factors that could affect pain level experience during treatment, including gender, age, brackets types, hygiene level and habitude.

Detailed description: To interpret the average pain level experience in orthodontic treatment and find correlations of different pain level within each individual from the clinical reports and questionnaires collected from each patient.

Eligibility criteria: Inclusion Criteria:

* Patient with orthodontic treatment over 2 months and less than 12 months
* Patient with braces or Invisalign
* Patient who goes to orthodontic visits routinely

Exclusion Criteria:

* Patient undergoing orthopaedic treatment (Functional appliances, 2x4 braces placement, maxillary expansion)
* Patient who do not understand Spanish
* Patient with cognitive impairment
* Patient who do not want to participate in the study
* Patient who have complete their orthodontic treatment

Primary outcomes:
measure: Pain level difference within different orthodontic appliances
timeFrame: From date of randomisation until the date of a 150 participation. Through study completion, an average of 1 year
Secondary outcomes:
measure: Pain level difference within different factors
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Centro Odonologico Innovacion y Especilidades Avanzadas
Study officials:
affiliation: University Alfonso X El Sabio
name: Chia Jung Lee
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scheurer PA, Firestone AR, Burgin WB. Perception of pain as a result of orthodontic treatment with fixed appliances. Eur J Orthod. 1996 Aug;18(4):349-57. doi: 10.1093/ejo/18.4.349.
citation: Cardoso PC, Espinosa DG, Mecenas P, Flores-Mir C, Normando D. Pain level between clear aligners and fixed appliances: a systematic review. Prog Orthod. 2020 Jan 20;21(1):3. doi: 10.1186/s40510-019-0303-z.
citation: Krukemeyer AM, Arruda AO, Inglehart MR. Pain and orthodontic treatment. Angle Orthod. 2009 Nov;79(6):1175-81. doi: 10.2319/121308-632R.1.
citation: Banerjee S, Banerjee R, Shenoy U, Agarkar S, Bhattacharya S. Effect of orthodontic pain on quality of life of patients undergoing orthodontic treatment. Indian J Dent Res. 2018 Jan-Feb;29(1):4-9. doi: 10.4103/ijdr.IJDR_113_16.
citation: Kafle D, Rajbhandari A. Anticipated pain and pain experience among orthodontic patients: is there any difference? Kathmandu Univ Med J (KUMJ). 2012 Apr-Jun;10(38):71-3. doi: 10.3126/kumj.v10i2.7348.
citation: Nicotra C, Polizzi A, Zappala G, Leonida A, Indelicato F, Caccianiga G. A Comparative Assessment of Pain Caused by the Placement of Banded Orthodontic Appliances with and without Low-Level Laser Therapy: A Randomized Controlled Prospective Study. Dent J (Basel). 2020 Mar 4;8(1):24. doi: 10.3390/dj8010024.