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

Sponsor

University of Guadalajara (Other)

Overall Status

Recruiting

CT.gov ID

NCT05383820

Collaborator

(none)

Enrollment

Location

Arms

14.7

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Malocclusion Pain, Acute	Drug: Ketorolac	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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).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:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Blinded, the orthodontist performing the clinical intervention and the investigator

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Sep 27, 2021

Actual Primary Completion Date :

Mar 10, 2022

Anticipated Study Completion Date :

Dec 18, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: Placebo

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

Drug: Ketorolac

Other Names:

Parcetamol

Experimental: Ketorolac

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

Drug: Ketorolac

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

Other Names:

Parcetamol

Outcome Measures

Primary Outcome Measures

Leves RANK-L [Baseline, 24 hours, 48 hours, and on day 5 of initiation of treatment.]
Leves Gingival Crevicular Fluid of RANK-L

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 27 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.