Factors Associated With Pain Level Experience in Orthodontic Treatment

Pain Clinical Trial

Official title:

Factors Associated With Pain Level Experience in Orthodontic Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04834466
• Other study ID #: AlfonsoXElSabioU
• Status: Recruiting
• Start date: February 4, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: April 2021
• Source: Alfonso X El Sabio University
• Contact: Chia Jung Lee
• Phone: +34603745177
• Email: jody929lee2012[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Orthodontic Appliance Complication
• Orthodontic Pain
• Pain

Intervention

Behavioral:
• Pain Level experience during orthodontic treatment
A questionnaire was given to patients who have started their orthodontic treatment to assess their pain level experience

Locations

Country	Name	City	State
Spain	Centro Odonologico Innovacion y Especilidades Avanzadas	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Chia Jung Lee	Shen Gaang Jong Shiaw Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View Citation

Nicotra C, Polizzi A, Zappalà 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). pii: E24. doi: 10.3390/dj8010024. — View Citation

Scheurer PA, Firestone AR, Bürgin WB. Perception of pain as a result of orthodontic treatment with fixed appliances. Eur J Orthod. 1996 Aug;18(4):349-57. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level difference within different orthodontic appliances	Orthodontic appliances such as Invisalign, conventional braces and self-ligated braces are included to compare. Pain assessed through visual analogue scale (VAS) rating 0(No pain) to 10(extreme pain) were given individually to participant with different orthodontic appliances to gather information. The lower the score, the lesser the pain and vise versa.	From date of randomisation until the date of a 150 participation. Through study completion, an average of 1 year
Secondary	Pain level difference within different factors	Factors such as gender, age, hygiene level, tooth discrepancies, habitude and mental state could affect the pain level experience during orthodontic treatment. Survey given with respective questions and pain assessed through visual analogue scale (VAS) rating 0(no pain) to 10(extreme pain) were given individually to participant to gather information. The lower the score, the lesser the pain and vise versa.	Through study completion, an average of 1 year.

External Links

•   Online consent form for the survey
•   Questionnaire designed and distributed through this website
•   The Visual analogue Scale (VAS) for pain assessment