Effect of Paracetamol and Ketorolac on RANK-L Levels in Patients Starting Orthodontic Treatment

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.

Study Overview

• Status: Recruiting
• Conditions: Malocclusion; Pain, Acute
• Intervention / Treatment: Drug: Ketorolac

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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Juan Ramón Gómez, PhD; Phone Number: 34040 1058 52 00; Email: juan.ramongom@academicos.udg.mx
• Study Contact Backup: Name: Juan Ramón Gómez, PhD; Phone Number: 34040 1058 52 00; Email: drjrgomez@gmail.com

Study Locations

• Mexico
  • Jaisco
    • Guadalajara, Jaisco, Mexico, 44340
      • Recruiting
      • Juan Ramón Gómez Sandoval
      • Contact: Juan Ramón Gómez, PhD; Phone Number: 34040 1058 52 00; Email: juan.ramongom@academicos.udg.mx
      • Contact: Juan Ramón Gómez, PhD; Phone Number: 34040 1058 52 00; Email: drjrgomez@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 27 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients of both sexes between 18 and 27 years of age
• Periodontally and systematically healthy
• Attended the Orthodontic Clinic of the University of Guadalajara
• Who required the use of dental spacers in at least one quadrant were included

Exclusion Criteria:

• Patients who have previously had orthodontic treatment or are under orthodontic treatment
• Who have an allergy to ketorolac or paracetamol
• Who are under pharmacological treatment and/or using contraceptives
• Pregnant or lactating women, as well as those who consume alcohol were not included or tobacco.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo (calcined magnesia) in capsules, one capsule every 8 hours 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).; Other Names: Parcetamol
Experimental: Ketorolac; Ketorolac 10 mg capsules, one capsule every 8 hours (30 mg daily) 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).; Other Names: Parcetamol
Active Comparator: Paracetamol; 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).; Other Names: Parcetamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leves RANK-L	Leves Gingival Crevicular Fluid of RANK-L	Baseline, 24 hours, 48 hours, and on day 5 of initiation of treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scale	Visual Analogue Pain Scale (APS)	Baseline, 24 hours, 48 hours, and on day 5 of initiation of treatment.
Intermolar Space (IS)	It is the space between the molars	5 days of initiation of treatment.

Collaborators and Investigators

• Sponsor: University of Guadalajara

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Actual): March 10, 2022
• Study Completion (Anticipated): December 18, 2022

Study Registration Dates

• First Submitted: September 4, 2021
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Paracetamol; Gingival crevicular fluid; Ketorolac; Orthodontics; RANK-L
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Malocclusion; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac
• Other Study ID Numbers: CI04820

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No