A Phase 4 interventional study of Ketorolac in Malocclusion and Pain, Acute, sponsored by University of Guadalajara. Status unknown at 1 site in Mexico. Open to participants aged 18 Years to 27 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-20.
Sponsored by University of Guadalajara · Phase 4, Interventional, and Basic science
Due to the high prevalence of malocclusions in Mexico and the existing concern to improve aesthetics, function (chewing), or both, patients resort to orthodontic treatment. The patient may experience pain during treatment due to the release of different chemical mediators such as RANK-L. Analgesic and anti-inflammatory medications such as acetaminophen and ketorolac are used to control pain during orthodontic tooth movement. These drugs can inhibit the expression of RANK-L which can affect tooth movement, inhibiting bone remodeling. The orthodontist should indicate the drug that is safest for the patient without affecting treatment or tooth movement.
Objective: To evaluate the association of RANK-L levels with the administration of paracetamol and ketorolac in patients starting orthodontic treatment.
Material and methods: A double-blind clinical trial will be carried out with a placebo control group and random drug allocation. Patients who begin orthodontic treatment in the Orthodontic Specialty of the Comprehensive Dental Clinics of the University Center for Health Sciences and who decide to participate in the study with the signing of informed consent will be included. Three groups will be formed with 8 patients in each one.
The first group will be administered with Placebo (calcined magnesia), the second group with Ketorolac and the third group with Paracetamol, for all groups the medication will be one capsule every 6 hours for 5 days all study subjects will be sampled Gingival Crevicular Fluid (LGC), Visual Analogue Pain Scale (APS) and Intermolar Space (IS).
Measurements will be made four times; baseline, 24 h, 48 h, and on day 5 of initiation of treatment.
457 studies on the registry are indexed under Malocclusion; 89 are open to participants now.
This study's planned enrollment of 24 is below the median of 36 across 372 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →University of Guadalajara is the lead sponsor of 94 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Placebo (calcined magnesia) in capsules, one capsule every 8 hours for 5 days.
Drug: Ketorolac
Ketorolac 10 mg capsules, one capsule every 8 hours (30 mg daily) for 5 days.
Drug: Ketorolac
Paracetamol capsules of 500 mg, one capsule every 8 hours (1.5 g per day) for 5 days.
Drug: Ketorolac
The first group will be administered with Placebo (calcined magnesia), the second group with Ketorolac and the third group with Paracetamol, for all groups the medication will be one capsule every 6 hours for 5 days all study subjects will be sampled Gingival Crevicular Fluid (LGC), Visual Analogue Pain Scale (APS) and Intermolar Space (IS).
Also known as: Parcetamol
Leves RANK-L
Leves Gingival Crevicular Fluid of RANK-L
Time frame: Baseline, 24 hours, 48 hours, and on day 5 of initiation of treatment.
Pain scale
Visual Analogue Pain Scale (APS)
Time frame: Baseline, 24 hours, 48 hours, and on day 5 of initiation of treatment.
Intermolar Space (IS)
It is the space between the molars
Time frame: 5 days of initiation of treatment.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University of Guadalajara