Factors Associated With Pain Level Experience in Orthodontic Treatment

• Conditions: Pain; Orthodontic Pain; Orthodontic Appliance Complication

• Registration Number: NCT04834466
• Lead Sponsor: Chia Jung Lee

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.

Study Timeline

• Study Start: 2021-02-04
• Study First Submitted: 2021-03-19
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-04
• Last Update Submitted: 2021-04-04
• Study First Posted: 2021-04-08
• Last Update Posted: 2021-04-08
• Primary Completion: 2022-02-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain level difference within different orthodontic appliances	From date of randomisation until the date of a 150 participation. Through study completion, an average of 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Pain level difference within different factors	Through study completion, an average of 1 year.	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.

Trial Locations

Locations (1)

Centro Odonologico Innovacion y Especilidades Avanzadas; 🇪🇸 Madrid, Spain