NCT03568721 (PECI) is a Phase 4 clinical trial of Ibuprofen in Pain, sponsored by Rio de Janeiro State University.

Who is sponsoring NCT03568721?

NCT03568721 is sponsored by Rio de Janeiro State University.

What drugs are being tested in NCT03568721?

Interventions in NCT03568721: Ibuprofen, Acetaminophen, Chewing gum.

Is NCT03568721 still recruiting?

NCT03568721 is currently completed. Last updated 3 December 2018.

Last reviewed 2018-12-03 · How we verify

NCT03568721: PECI

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Last updated 3 December 2018

What this trial tests

Phase 4 trial testing Ibuprofen in Pain in 81 participants. Completed in 20 May 2018.

Timeline

25 January 2015

Primary endpoint
18 March 2018

20 May 2018

Quick facts

Lead sponsor	Rio de Janeiro State University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	81
Start date	25 January 2015
Primary completion	18 March 2018
Estimated completion	20 May 2018
Sites	1 location across Brazil

Drugs / interventions tested

Ibuprofen (ibuprofen) — full drug profile →
Acetaminophen (Paracetamol) — full drug profile →
Chewing gum — full drug profile →

Conditions studied

Pain — all drugs for Pain →

Sponsor

Rio de Janeiro State University

Who can join

Adults 12 to 55, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Chewing gum as a non-pharmacological alternative for orthodontic pain relief: A randomized clinical trial using an intention-to-treat analysis.
Santos DJDS, Jr JC. · · 2021 · cited 9× · PMID 34556589 · DOI 10.4041/kjod.2021.51.5.346

Verify or expand the search:

Other trials of Ibuprofen

Trials testing the same drug.

NCT07401927 — Preemptive Analgesia in Laparoscopic Hysterectomy · not yet recruiting
NCT07565012 — Comparative Evaluation of Diclofenac Sodium and Ibuprofen for Post-Endodontic Pain Management · Phase 4 · completed
NCT06671002 — Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial · Phase 4 · recruiting
NCT06505148 — Comparing the Difference in Pain Control in the Pediatric General Surgery Population: to Alternate or Combine Acetaminop · Phase 4 · not yet recruiting
NCT05935306 — Effect of Photobiomodulation to Reduce Post-operative Pain After Endodontic Surgery · NA · recruiting

Other recruiting trials for Pain

Currently open trials in the same condition.

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NCT07487610 — Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older · recruiting
NCT07454993 — The Effect of Music During Colonoscopy · NA · recruiting

Other Rio de Janeiro State University trials

Trials by the same sponsor.

NCT06799598 — DUOSTIM and AI: is There a Difference Between Oocyte Performance in the Follicular and Luteal Phases? · completed
NCT05931939 — Laparoscopic Ileal Interposition and Weight Regain · NA · recruiting
NCT04193397 — Effects of Physical Training on Health Markers of Post-bariatric Patients · NA · completed
NCT05950698 — Obesity and Bariatric Surgery According to a Biopsychosocial Perspective. · recruiting
NCT05728320 — Glycemic Patterns After Bariatric Surgery and High Glycemic Variability and Hypoglycemia Unawareness Risk Factors · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03568721 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rio de Janeiro State University
Last refreshed: 3 December 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03568721.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing