Factors Associated With Pain Level Experience in Orthodontic Treatment

NCT ID: NCT04834466

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-04

Study Completion Date

2022-03-01

Brief Summary

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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

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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.

Conditions

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Orthodontic Pain Pain Orthodontic Appliance Complication

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Pain Level experience during orthodontic treatment

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shen Gaang Jong Shiaw Hospital

UNKNOWN

Sponsor Role collaborator

Chia Jung Lee

OTHER

Sponsor Role lead

Responsible Party

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Chia Jung Lee

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Chia Jung Lee

Role: PRINCIPAL_INVESTIGATOR

University Alfonso X El Sabio

Locations

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Centro Odonologico Innovacion y Especilidades Avanzadas

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Chia Jung Lee

Role: CONTACT

+34603745177

Facility Contacts

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Patricia CINTORA LOPEZ

Role: primary

+34914402330

References

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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.

Reference Type BACKGROUND
PMID: 8921656 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31956934 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 19852612 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29442079 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23132480 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32143365 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://www.surveyhero.com

Questionnaire designed and distributed through this website

Other Identifiers

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AlfonsoXElSabioU

Identifier Type: -

Identifier Source: org_study_id

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