Clinical trial NCT03568721: Postoperative Effects of Chewing Gum, Ibuprofen and Acetaminophen on Pain After Initial Archwire Placement
Official title: Postoperative Effects of Chewing Gum, Ibuprofen and Acetaminophen on Pain After Initial Archwire Placement: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: pain
orthodontics
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2018-06-26
Enrollment: 81
Sex: ALL
Minimum age (years): 12
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Orthodontic pain measurement by marking 100 millimeters visual analogue scales.
timeFrame: 2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.
Secondary outcomes:
measure: Chewing gum as a non pharmacologic alternative for orthodontic pain control by marking 100 millimeters visual analogue scales.
timeFrame: 2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.
measure: Pain at rest X fitting back teeth by marking 100 millimeters visual analogue scales.
timeFrame: 2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Rio de Janeiro State University
Study officials:
affiliation: Rio de Janeiro State University
name: DIEGO J SANTOS, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Rio de Janeiro State University
name: JONAS CAPELLI, PhD
role: STUDY_DIRECTOR
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