Orthodontic Pain (D013850)Phase 1EOSCOX2NCT07559682
Efficacy of Selective COX-2 Inhibitors in Relieving Orthodontic Pain
A Phase 1 study testing Celecoxib and Etoricoxib (Treatment Group) in people with Orthodontic Pain (D013850), run by Sharif Medical Research Center at 1 site in Pakistan.
Trial summary
The purpose of this study is to compare the efficacy of selective COX-2 inhibitors{ etoricoxib vs celecoxib )in relieving orthodontic pain , after initial bonding and arch wire insertion. Read more about this study
- Who is it for?
- Ages 13 to 30 years
- Conditions the study is for
- Orthodontic Pain (D013850)
- What is being tested?
- Celecoxib and Etoricoxib (Treatment Group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- 8 May 2025to 30 Apr 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 13 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 13 to 30 years
- Fully erupted permanent dentition excluding third molars
- Mild crowding (0 -4mm)
Who cannot join
- Active periodontitis
- Deep cavities or large restorations
- Previous dental extraction in less than 4 weeks before bonding
- History of steroid use within last 6 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Selective COX-2 Inhibitors in Relieving Orthodontic Pain ;a Randomized Controlled Trial
The purpose of this study is to compare the efficacy of selective COX-2 inhibitors{ etoricoxib vs celecoxib )in relieving orthodontic pain , after initial bonding and arch wire insertion.
- Conditions
- Orthodontic Pain (D013850)
- Being tested
- Celecoxib, Etoricoxib (Treatment Group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Group A will be given Celecoxib 50mg once a day.
Etoricoxib (Treatment Group)Drug
Group B will be given Etoricoxib 60mg once a day.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A will be given Celecoxib medicine. Receives: Drug: Celecoxib |
| Group B | Active comparator | Group B will be given Etoricoxib medicine. Receives: Drug: Etoricoxib (Treatment Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain scores will be measured using a 10cm Visual Analogue Scale (VAS) , The Scale consists of a horizontal line anchored by two verbal descriptions where 0 represented '' No Pain '' and 10 represented ''Maximum Pain''. The Score is determined by measuring the distance from left end of the scale to the mark made by the participant.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start8 May 2025
- Primary completion18 Aug 2025
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Pain (D013850)Studies 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 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharif Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faiza Malik, BDS, FCPS, Study chair, Essentia Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559682
- Sponsor's protocol ID
- SMDC/SMRC/289-23
- Acronym
- EOSCOX2
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 30 Apr 2026
- 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Selective COX-2 Inhibitors in Relieving Orthodontic Pain ;a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07559682
- Acronym / sponsor ID
- EOSCOX2 / SMDC/SMRC/289-23
- Conditions
- Orthodontic Pain (D013850)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sharif Medical Research CenterUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 30 Apr 2026 (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.
The purpose of this study is to compare the efficacy of selective COX-2 inhibitors{ etoricoxib vs celecoxib )in relieving orthodontic pain , after initial bonding and arch wire insertion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: CelecoxibGroup A will be given Celecoxib medicine. |
| Group B | Active comparator | Drug: Etoricoxib (Treatment Group)Group B will be given Etoricoxib medicine. |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 13 to 30 years
- Fully erupted permanent dentition excluding third molars
- Mild crowding (0 -4mm)
Key exclusion criteria (4 listed)
- Active periodontitis
- Deep cavities or large restorations
- Previous dental extraction in less than 4 weeks before bonding
- History of steroid use within last 6 weeks
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 |
|---|---|---|
| CelecoxibGroup A will be given Celecoxib 50mg once a day. | Drug | Group A |
| Etoricoxib (Treatment Group)Group B will be given Etoricoxib 60mg once a day. | Drug | Group B |
Primary outcome
Pain intensity
Time frame: 1 year
Pain scores will be measured using a 10cm Visual Analogue Scale (VAS) , The Scale consists of a horizontal line anchored by two verbal descriptions where 0 represented '' No Pain '' and 10 represented ''Maximum Pain''. The Score is determined by measuring the distance from left end of the scale to the mark made by the participant.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- 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.
Faiza Malik, BDS, FCPS study chair
Essentia Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Celecoxib and Etoricoxib (Treatment Group) in people with Orthodontic Pain (D013850), run by Sharif Medical Research Center at 1 site in Pakistan.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. 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 Pakistan. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 1 year). 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 30 Apr 2026.