search
Back to results

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

Primary Purpose

Malocclusion, Pain, Acute

Status
Recruiting
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Ketorolac
Sponsored by
University of Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Malocclusion focused on measuring Orthodontics, RANK-L, Ketorolac, Paracetamol, Gingival crevicular fluid

Eligibility Criteria

18 Years - 27 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Juan Ramón Gómez SandovalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Placebo

Ketorolac

Paracetamol

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Leves RANK-L
Leves Gingival Crevicular Fluid of RANK-L

Secondary Outcome Measures

Pain scale
Visual Analogue Pain Scale (APS)
Intermolar Space (IS)
It is the space between the molars

Full Information

First Posted
September 4, 2021
Last Updated
May 16, 2022
Sponsor
University of Guadalajara
search

1. Study Identification

Unique Protocol Identification Number
NCT05383820
Brief Title
Effect of Paracetamol and Ketorolac on RANK-L Levels in Patients Starting Orthodontic Treatment
Official Title
Effect of Paracetamol and Ketorolac on RANK-L Levels in Patients Starting Orthodontic Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
March 10, 2022 (Actual)
Study Completion Date
December 18, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guadalajara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Pain, Acute
Keywords
Orthodontics, RANK-L, Ketorolac, Paracetamol, Gingival crevicular fluid

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
ParticipantCare ProviderInvestigator
Masking Description
Blinded, the orthodontist performing the clinical intervention and the investigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (calcined magnesia) in capsules, one capsule every 8 hours for 5 days.
Arm Title
Ketorolac
Arm Type
Experimental
Arm Description
Ketorolac 10 mg capsules, one capsule every 8 hours (30 mg daily) for 5 days.
Arm Title
Paracetamol
Arm Type
Active Comparator
Arm Description
Paracetamol capsules of 500 mg, one capsule every 8 hours (1.5 g per day) for 5 days.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Parcetamol
Intervention Description
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).
Primary Outcome Measure Information:
Title
Leves RANK-L
Description
Leves Gingival Crevicular Fluid of RANK-L
Time Frame
Baseline, 24 hours, 48 hours, and on day 5 of initiation of treatment.
Secondary Outcome Measure Information:
Title
Pain scale
Description
Visual Analogue Pain Scale (APS)
Time Frame
Baseline, 24 hours, 48 hours, and on day 5 of initiation of treatment.
Title
Intermolar Space (IS)
Description
It is the space between the molars
Time Frame
5 days of initiation of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JUAN RAMÓN GÓMEZ, PhD
Phone
1058 52 00
Ext
34040
Email
juan.ramongom@academicos.udg.mx
First Name & Middle Initial & Last Name or Official Title & Degree
JUAN RAMÓN GÓMEZ, PhD
Phone
1058 52 00
Ext
34040
Email
drjrgomez@gmail.com
Facility Information:
Facility Name
Juan Ramón Gómez Sandoval
City
Guadalajara
State/Province
Jaisco
ZIP/Postal Code
44340
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Ramón Gómez, PhD
Phone
1058 52 00
Ext
34040
Email
juan.ramongom@academicos.udg.mx
First Name & Middle Initial & Last Name & Degree
Juan Ramón Gómez, PhD
Phone
1058 52 00
Ext
34040
Email
drjrgomez@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs