MalocclusionPhase 4NCT05383820
Effect of Paracetamol and Ketorolac on RANK-L Levels in Patients Starting Orthodontic Treatment
A Phase 4 study testing Ketorolac in people with Malocclusion and Pain, Acute, run by University of Guadalajara at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Pain, Acute
- What is being tested?
- Ketorolac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteMexico
- Study dates
- 27 Sep 2021to 18 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Juan Ramón Gómez Sandoval
Guadalajara, Jaisco, 44340
Juan Ramón Gómez, PhD, 1058 52 00 ext. 34040, juan.ramongom@academicos.udg.mx
Juan Ramón Gómez, PhD, 1058 52 00 ext. 34040, drjrgomez@gmail.com
About this study
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.
Read the 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.
- Conditions
- Malocclusion, Pain, Acute
- Being tested
- Ketorolac
- Keywords
- Orthodontics, RANK-L, Ketorolac, Paracetamol, Gingival crevicular fluid
- Medical subject headings
- Malocclusion, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Also called Parcetamol
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 group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (calcined magnesia) in capsules, one capsule every 8 hours for 5 days. Receives: Drug: Ketorolac |
| Ketorolac | Experimental | Ketorolac 10 mg capsules, one capsule every 8 hours (30 mg daily) for 5 days. Receives: Drug: Ketorolac |
| Paracetamol | Active comparator | Paracetamol capsules of 500 mg, one capsule every 8 hours (1.5 g per day) for 5 days. Receives: Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leves RANK-L
Leves Gingival Crevicular Fluid of RANK-L
Measured: Baseline, 24 hours, 48 hours, and on day 5 of initiation of treatment.
Secondary outcomes (2)
Pain scale
Visual Analogue Pain Scale (APS)
Measured: Baseline, 24 hours, 48 hours, and on day 5 of initiation of treatment.
Intermolar Space (IS)
It is the space between the molars
Measured: 5 days of initiation of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start27 Sep 2021
- Primary completion10 Mar 2022
- Study completion18 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Ramon Gomez Sandoval, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383820
- Sponsor's protocol ID
- CI04820
- Status last verified
- May 2022
- First submitted
- 4 Sep 2021
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Paracetamol and Ketorolac on RANK-L Levels in Patients Starting Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT05383820
- Acronym / sponsor ID
- CI04820
- Conditions
- Malocclusion, Pain, Acute
- Keywords
- Orthodontics, RANK-L, Ketorolac, Paracetamol, Gingival crevicular fluid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 18 Dec 2022 (estimated)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: KetorolacPlacebo (calcined magnesia) in capsules, one capsule every 8 hours for 5 days. |
| Ketorolac | Experimental | Drug: KetorolacKetorolac 10 mg capsules, one capsule every 8 hours (30 mg daily) for 5 days. |
| Paracetamol | Active comparator | Drug: KetorolacParacetamol capsules of 500 mg, one capsule every 8 hours (1.5 g per day) for 5 days. |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetorolacAlso: ParcetamolThe 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). | Drug | Ketorolac, Paracetamol, Placebo |
Primary outcome
Leves RANK-L
Time frame: Baseline, 24 hours, 48 hours, and on day 5 of initiation of treatment.
Leves Gingival Crevicular Fluid of RANK-L
2 secondary outcomes
Pain scale
Time frame: Baseline, 24 hours, 48 hours, and on day 5 of initiation of treatment.
Intermolar Space (IS)
Time frame: 5 days of initiation of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketorolac in people with Malocclusion and Pain, Acute, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JUAN RAMÓN GÓMEZ, PhD (1058 52 00 ext. 34040, juan.ramongom@academicos.udg.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leves RANK-L (time frame: Baseline, 24 hours, 48 hours, and on day 5 of initiation of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.