NCT03953729

Effectiveness of Pre-emptive Analgesia in Children With Molar-incisor Hypomineralization (MIH)

Status unknown EARLY_PHASE1 Last updated 28 September 2021

What this trial tests

EARLY_PHASE1 trial testing Ibuprofen in Pain in 50 participants. Status unknown.

Timeline

1 April 2019

Primary endpoint
20 October 2021

20 December 2021

Quick facts

Lead sponsor	University of Sao Paulo
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	supportive care
Enrollment	50
Start date	1 April 2019
Primary completion	20 October 2021
Estimated completion	20 December 2021
Sites	1 location across Brazil

Drugs / interventions tested

• Ibuprofen (ibuprofen) — full drug profile →
• Placebo

Conditions studied

• Pain — all drugs for Pain →
• Anxiety — all drugs for Anxiety →

Sponsor

University of Sao Paulo

Who can join

Adults 6 to 12, any sex, with Pain or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pain is defined by IASP (International Association for the Study of Pain) as "an unpleasant sensory and emotional experience associated with the damage actual or potential tissue or described in terms that suggest such harm". Episodes of pain and discomfort experienced by children are one of the main factors for fear and anxiety in dentistry, especially those that present the condition of Molar-Incisive Hipomineralization, where we observed increased levels of anxiety in relation to the treatment. In order to improve the painful sensation that patients with Molar-Incisor Hipomineralization present as well as anxiety demonstrated by these patients in face of dental treatment, the objective of present study will be to evaluate the occurrence and degree of pain after procedures dentists with administration of pre-emptive analgesia or placebo, in children with Molar-Incisive Hipomineralization. Fifty patients will be selected in the Pediatric Dentistry courses of the FORP-USP undergraduate course, aged 6 to 12 years, of both sexes, who present at least 2 (two) upper and / or lower molars affected by Molar- Incisors that need some kind of restorative treatment, extraction or endodontic treatment. Also, these patients should present enamel and dentin fractures caused by MIH, atypical restoration and / or atypical caries, and that present pain above the moderate degree (6\>), after stimulation with air/water jet for 5 seconds.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ibuprofen for acute postoperative pain in children.
   Pessano S, Gloeck NR, Tancredi L, Ringsten M, et al · · 2024 · cited 7× · PMID 38180091 · DOI 10.1002/14651858.cd015432.pub2
2. Preemptive analgesia with ibuprofen increases anesthetic efficacy in children with severe molar: a triple-blind randomized clinical trial.
   Vicioni-Marques F, Paula-Silva FWG, Carvalho MR, Queiroz AM, et al · · 2022 · cited 7× · PMID 35476115 · DOI 10.1590/1678-7757-2021-0538