Factors Associated With Pain Level Experience in Orthodontic Treatment

April 4, 2021 updated by: Chia Jung Lee
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28037
        • Recruiting
        • Centro Odonologico Innovacion y Especilidades Avanzadas
        • Contact:
          • Patricia CINTORA LOPEZ
          • Phone Number: +34914402330
          • Email: info@UAX.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from Clinic Centro Odontologo Innovaccion y especialidad avanzadas who are undergoing orthodontic treatment were selected.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level difference within different orthodontic appliances
Time Frame: 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.
From date of randomisation until the date of a 150 participation. Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level difference within different factors
Time Frame: 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.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Jung Lee

Collaborators

Shen Gaang Jong Shiaw Hospital

Investigators

  • Principal Investigator: Chia Jung Lee, University Alfonso X El Sabio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2021

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

April 4, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 4, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • AlfonsoXElSabioU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data could be shared for further analysis or comparison to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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