NCT04834466

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 19, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

12 months

First QC Date

March 19, 2021

Last Update Submit

April 4, 2021

Conditions

Orthodontic PainPainOrthodontic Appliance Complication

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Pain level difference within different factors

    Through study completion, an average of 1 year.

Interventions

Pain Level experience during orthodontic treatmentBEHAVIORAL

A questionnaire was given to patients who have started their orthodontic treatment to assess their pain level experience

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Odonologico Innovacion y Especilidades Avanzadas

Madrid, 28037, Spain

RECRUITING

Related Publications (6)

  • 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.

    PMID: 8921656BACKGROUND

  • 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.

    PMID: 31956934BACKGROUND

  • Krukemeyer AM, Arruda AO, Inglehart MR. Pain and orthodontic treatment. Angle Orthod. 2009 Nov;79(6):1175-81. doi: 10.2319/121308-632R.1.

    PMID: 19852612BACKGROUND

  • 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.

    PMID: 29442079BACKGROUND

  • 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.

    PMID: 23132480BACKGROUND

  • 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.

    PMID: 32143365BACKGROUND

Related Links

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chia Jung Lee

    University Alfonso X El Sabio

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia Jung Lee

CONTACT

+34603745177jody929lee2012@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 19, 2021

First Posted

April 8, 2021

Study Start

February 4, 2021

Primary Completion

February 1, 2022

Study Completion

March 1, 2022

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations

ES(1)