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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03568721
Acronym
PECI
Enrollment
81
Registered
2018-06-26
Start date
2015-01-25
Completion date
2018-05-20
Last updated
2018-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

pain, orthodontics

Brief 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. 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.

Interventions

DRUGIbuprofen

prescription of ibuprofen 400 mg

DRUGAcetaminophen

prescription of acetaminophen 500 mg

OTHERChewing gum

prescription of one tablet of chewing gum

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
Rio de Janeiro State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Orthodontic pain measurement by marking 100 millimeters visual analogue scales.2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.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.

Secondary

MeasureTime frameDescription
Chewing gum as a non pharmacologic alternative for orthodontic pain control by marking 100 millimeters visual analogue scales.2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.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.
Pain at rest X fitting back teeth by marking 100 millimeters visual analogue scales.2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026