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

NCT05383820 | Unknown Phase 4 DMC

• 1 other identifier: CI04820
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion; Pain, Acute

Keywords

Orthodontics; RANK-L; Ketorolac; Paracetamol; Gingival crevicular fluid

Outcome Measures

Primary Outcomes (1)

• Leves RANK-L

  Leves Gingival Crevicular Fluid of RANK-L

  Baseline, 24 hours, 48 hours, and on day 5 of initiation of treatment.

Secondary Outcomes (2)

• Pain scale

  Baseline, 24 hours, 48 hours, and on day 5 of initiation of treatment.

• Intermolar Space (IS)

  5 days of initiation of treatment.

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo (calcined magnesia) in capsules, one capsule every 8 hours for 5 days.

Drug: Ketorolac

Ketorolac

EXPERIMENTAL

Ketorolac 10 mg capsules, one capsule every 8 hours (30 mg daily) for 5 days.

Drug: Ketorolac

Paracetamol

ACTIVE COMPARATOR

Paracetamol capsules of 500 mg, one capsule every 8 hours (1.5 g per day) for 5 days.

Drug: Ketorolac

Interventions

Ketorolac DRUG

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

Ketorolac; Paracetamol; Placebo

Eligibility Criteria

• Age: 18 Years - 27 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Juan Ramón Gómez Sandoval

Guadalajara, Jaisco, 44340, Mexico

RECRUITING

MeSH Terms

Conditions

Malocclusion; Acute Pain

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

JUAN RAMÓN GÓMEZ, PhD

CONTACT

1058 52 00; juan.ramongom@academicos.udg.mx

JUAN RAMÓN GÓMEZ, PhD

CONTACT

1058 52 00; drjrgomez@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Blinded, the orthodontist performing the clinical intervention and the investigator
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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).

Study Record Dates

• First Submitted: September 4, 2021
• First Posted: May 20, 2022
• Study Start: September 27, 2021
• Primary Completion: March 10, 2022
• Study Completion: December 18, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)