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PainPhase 4PECINCT03568721

Postoperative Effects of Chewing Gum, Ibuprofen and Acetaminophen on Pain After Initial Archwire Placement

A Phase 4 study testing Ibuprofen, Acetaminophen and Chewing gum in people with Pain, run by Rio de Janeiro State University at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the efficacy of ibuprofen, acetaminophen, chewing gum in reducing orthodontic pain. This study include 81 patients to be classified into 4 groups of 19 each: ibuprofen (400 mg), acetaminophen (500 mg), chewing gum and control. Read more about this study

Who is it for?
Ages 12 to 55 years
Conditions the study is for
Pain
What is being tested?
Ibuprofen, Acetaminophen and Chewing gum
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteBrazil
Study dates
25 Jan 2015to 20 May 2018
Phase
Phase 4
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 12 to 55 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • moderate teeth crowding
  • no need for tooth extraction to orthodontic reasons

Who cannot join

  • presence of autoimmune diseases
  • history of orthodontic treatment with fixed appliances

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Rio de Janeiro State University

    Rio de Janeiro, 20551-030

Other trials in Brazil

About this study

Official title: Postoperative Effects of Chewing Gum, Ibuprofen and Acetaminophen on Pain After Initial Archwire Placement: a Randomized Controlled Trial

The purpose of this study is to compare the efficacy of ibuprofen, acetaminophen, chewing gum in reducing orthodontic pain. This study include 81 patients to be classified into 4 groups of 19 each: ibuprofen (400 mg), acetaminophen (500 mg), chewing gum and control. The patients in each group will receive 1 method immediately after placement of the initial archwire and every 6 hours for a week if they experiences pain. Pain perception will be recorded by the patients while jaw rest position and fitting back teeth at 2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement, using a visual analog scale.

Conditions
Pain
Being tested
Ibuprofen, Acetaminophen, Chewing gum
Keywords
pain, orthodontics
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IbuprofenDrug

    Also called non steroidal drug

    prescription of ibuprofen 400 mg

  • AcetaminophenDrug

    Also called paracetamol

    prescription of acetaminophen 500 mg

  • Chewing gumOther

    prescription of one tablet of chewing gum

Study groups in NCT03568721
Study groupRoleWhat they receive
ibuprofenExperimentalibuprofen (400 mg) immediately after insertion of the initial archwire and 6/6 hs for a week if there is any orthodontic pain.
Receives: Drug: Ibuprofen
acetaminophenExperimentalacetaminophen (500 mg) immediately after insertion of the initial archwire and 6/6 hs for a week if there is any orthodontic pain.
Receives: Drug: Acetaminophen
chewing gumExperimentalchewing gum (01 tablet) immediately after insertion of the initial archwire and 6/6 hs of chewing gum for a week if there is any orthodontic pain.
Receives: Other: Chewing gum
controlNo interventioncontrol (no reliever for orthodontic pain)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Orthodontic pain measurement by marking 100 millimeters visual analogue scales.

    to compare the efficacy of ibuprofen, acetaminophen and chewing gum in changing orthodontic pain by marking in between two points in a 100 millimeters visual analogue scale that starts from the left (no pain) and end to the right (exacerbated pain) at different time points.

    Measured: 2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.

Secondary outcomes (2)

  1. Chewing gum as a non pharmacologic alternative for orthodontic pain control by marking 100 millimeters visual analogue scales.

    to verify if chewing gum can be a non-pharmacologic method for orthodontic pain control by marking in between two points in a 100 millimeters visual analogue scale that starts from the left (no pain) and ends to the right (exacerbated pain) at different time points.

    Measured: 2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.

  2. Pain at rest X fitting back teeth by marking 100 millimeters visual analogue scales.

    to verify wich group has less pain and if in rest or in fitting back teeth by marking in between two points in a 100 millimeters visual analogue scale that starts from the left (no pain) and end to the right (exacerbated pain) at different time points.

    Measured: 2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2018
  2. Study start25 Jan 2015
  3. Primary completion18 Mar 2018
  4. Study completion20 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03568721
Sponsor's protocol ID
173112
Acronym
PECI
Status last verified
Nov 2018
First submitted
2 Jun 2018
Last updated
3 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Farzanegan F, Zebarjad SM, Alizadeh S, Ahrari F. Pain reduction after initial archwire placement in orthodontic patients: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2012 Feb;141(2):169-73. doi: 10.1016/j.ajodo.2011.06.042.

    PubMed 22284284

  • Sandhu SS, Sandhu J. Orthodontic pain: an interaction between age and sex in early and middle adolescence. Angle Orthod. 2013 Nov;83(6):966-72. doi: 10.2319/030113-174.1. Epub 2013 May 24.

    PubMed 23705940

  • Angelopoulou MV, Vlachou V, Halazonetis DJ. Pharmacological management of pain during orthodontic treatment: a meta-analysis. Orthod Craniofac Res. 2012 May;15(2):71-83. doi: 10.1111/j.1601-6343.2012.01542.x.

    PubMed 22515183

  • Bergius M, Berggren U, Kiliaridis S. Experience of pain during an orthodontic procedure. Eur J Oral Sci. 2002 Apr;110(2):92-8. doi: 10.1034/j.1600-0722.2002.11193.x.

    PubMed 12013568

  • Erdinc AM, Dincer B. Perception of pain during orthodontic treatment with fixed appliances. Eur J Orthod. 2004 Feb;26(1):79-85. doi: 10.1093/ejo/26.1.79.

    PubMed 14994886

  • Canavarro C, Teles RP, Capelli Junior J. Matrix metalloproteinases -1, -2, -3, -7, -8, -12, and -13 in gingival crevicular fluid during orthodontic tooth movement: a longitudinal randomized split-mouth study. Eur J Orthod. 2013 Oct;35(5):652-8. doi: 10.1093/ejo/cjs053. Epub 2012 Sep 17.

    PubMed 22989715

  • Davies GM, Worthington HV, Ellwood RP, Blinkhorn AS, Taylor GO, Davies RM, Considine J. An assessment of the cost effectiveness of a postal toothpaste programme to prevent caries among five-year-old children in the North West of England. Community Dent Health. 2003 Dec;20(4):207-10.

    PubMed 14696738

  • Ngan P, Kess B, Wilson S. Perception of discomfort by patients undergoing orthodontic treatment. Am J Orthod Dentofacial Orthop. 1989 Jul;96(1):47-53. doi: 10.1016/0889-5406(89)90228-x.

    PubMed 2750720

  • Hwang JY, Tee CH, Huang AT, Taft L. Effectiveness of thera-bite wafers in reducing pain. J Clin Orthod. 1994 May;28(5):291-2. No abstract available.

    PubMed 8613507

  • White LW. Pain and cooperation in orthodontic treatment. J Clin Orthod. 1984 Aug;18(8):572-5. No abstract available.

    PubMed 6595271

  • Krishnan V, Davidovitch Z. The effect of drugs on orthodontic tooth movement. Orthod Craniofac Res. 2006 Nov;9(4):163-71. doi: 10.1111/j.1601-6343.2006.00372.x.

    PubMed 17101023

  • Simmons KE, Brandt M. Control of orthodontic pain. J Indiana Dent Assoc. 1992 Jul-Aug;71(4):8-10.

    PubMed 1432346

  • Keith DJ, Rinchuse DJ, Kennedy M, Zullo T. Effect of text message follow-up on patient's self-reported level of pain and anxiety. Angle Orthod. 2013 Jul;83(4):605-10. doi: 10.2319/091812-742.1. Epub 2012 Dec 4.

    PubMed 23210546

  • Brown DF, Moerenhout RG. The pain experience and psychological adjustment to orthodontic treatment of preadolescents, adolescents, and adults. Am J Orthod Dentofacial Orthop. 1991 Oct;100(4):349-56. doi: 10.1016/0889-5406(91)70073-6.

    PubMed 1927986

  • Bergius M, Broberg AG, Hakeberg M, Berggren U. Prediction of prolonged pain experiences during orthodontic treatment. Am J Orthod Dentofacial Orthop. 2008 Mar;133(3):339.e1-8. doi: 10.1016/j.ajodo.2007.09.013.

    PubMed 18331926

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ibuprofen, Acetaminophen and Chewing gum in people with Pain, run by Rio de Janeiro State University at 1 site in Brazil.

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 2 inclusion and 2 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: finished, as of the sponsor's last update on 3 Dec 2018. 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 Brazil. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Orthodontic pain measurement by marking 100 millimeters visual analogue scales. (time frame: 2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.). 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 NCT03568721, which also lists 21 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 3 Dec 2018.

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