Orthodontic PainNCT04834466
Factors Associated With Pain Level Experience in Orthodontic Treatment
An observational study of Orthodontic Pain and Pain, run by Chia Jung Lee at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Pain, Pain, Orthodontic Appliance Complication
- What is being tested?
- Pain Level experience during orthodontic treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 4 Feb 2021to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients from Clinic Centro Odontologo Innovaccion y especialidad avanzadas who are undergoing orthodontic treatment were selected.
Who may be able to join
- Patient with orthodontic treatment over 2 months and less than 12 months
- Patient with braces or Invisalign
- Patient who goes to orthodontic visits routinely
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Centro Odonologico Innovacion y Especilidades Avanzadas
Madrid, 28037
Patricia CINTORA LOPEZ, +34914402330, info@UAX.es
About this study
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.
Read the 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.
- Conditions
- Orthodontic Pain, Pain, Orthodontic Appliance Complication
- Being tested
- Pain Level experience during orthodontic treatment
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Level experience during orthodontic treatmentBehavioural
A questionnaire was given to patients who have started their orthodontic treatment to assess their pain level experience
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start4 Feb 2021
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Orthodontic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Jung Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Shen Gaang Jong Shiaw Hospital
- Responsible party
- Sponsor-investigator, Chia Jung Lee, Alfonso X El Sabio University
- Investigators
- Chia Jung Lee, Principal investigator, University Alfonso X El Sabio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834466
- Sponsor's protocol ID
- AlfonsoXElSabioU
- Status last verified
- Apr 2021
- First submitted
- 19 Mar 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data could be shared for further analysis or comparison to other researchers
Publications
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.
PubMed 8921656Cardoso 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.
PubMed 31956934Krukemeyer AM, Arruda AO, Inglehart MR. Pain and orthodontic treatment. Angle Orthod. 2009 Nov;79(6):1175-81. doi: 10.2319/121308-632R.1.
PubMed 19852612Banerjee 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.
PubMed 29442079Kafle 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.
PubMed 23132480Nicotra 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.
PubMed 32143365
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Pain Level Experience in Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT04834466
- Acronym / sponsor ID
- AlfonsoXElSabioU
- Conditions
- Orthodontic Pain, Pain, Orthodontic Appliance Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chia Jung LeeUniversity, hospital or other
- Collaborators
- Shen Gaang Jong Shiaw Hospital
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from Clinic Centro Odontologo Innovaccion y especialidad avanzadas who are undergoing orthodontic treatment were selected.
Key inclusion criteria (3 listed)
- Patient with orthodontic treatment over 2 months and less than 12 months
- Patient with braces or Invisalign
- Patient who goes to orthodontic visits routinely
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Level experience during orthodontic treatmentA questionnaire was given to patients who have started their orthodontic treatment to assess their pain level experience | Behavioural | – |
Primary outcome
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.
1 secondary outcome
Pain level difference within different factors
Time frame: Through study completion, an average of 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Background: PubMed 8921656Scheurer 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.
- Background: PubMed 31956934Cardoso 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.
- Background: PubMed 19852612Krukemeyer AM, Arruda AO, Inglehart MR. Pain and orthodontic treatment. Angle Orthod. 2009 Nov;79(6):1175-81. doi: 10.2319/121308-632R.1.
- Background: PubMed 29442079Banerjee 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.
- Background: PubMed 23132480Kafle 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.
- Background: PubMed 32143365Nicotra 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.
- Online consent form for the surveyLink provided by the sponsor.
- Questionnaire designed and distributed through this websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Individual participant data could be shared for further analysis or comparison to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia Jung Lee principal investigator
University Alfonso X El Sabio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthodontic Pain and Pain, run by Chia Jung Lee at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia Jung Lee (+34603745177, jody929lee2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04834466, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.