Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT05383820
Status:
UNKNOWN
Last Update Posted:
2022-05-20
First Post:
2021-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Paracetamol and Ketorolac on RANK-L Levels in Patients Starting Orthodontic Treatment
Sponsor:
University of Guadalajara
Organization:
Study Overview
Official Title:
Effect of Paracetamol and Ketorolac on RANK-L Levels in Patients Starting Orthodontic Treatment
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: