Oral Soft Tissue ConditionsPhase 4NCT06238154
Flurbiprofen Tablet vs Spray In Oral Soft Tissue Wounds
A Phase 4 study testing Flurbiprofen in people with Oral Soft Tissue Conditions and Drug Effect, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
The amount of active ingredient in tablet form of flurbiprofen is higher than that in the oral spray form. Therefore, based on the hypothesis that the side effects that may occur depending on the dose can be reduced, this clinical study investigated whether tablet and spray form flurbiprofen would have similar effects… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Soft Tissue Conditions, Drug Effect, Drug Use
- What is being tested?
- Flurbiprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Oct 2023to 20 Jan 2024
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provided that those using removable prosthesis had discontinued using the prosthesis 1 month ago (in order to minimize the lesion to be excised), healthy or ASA Class I patients between 40 and 65 years of age, who had the indication of pre-prosthetic surgery due to excision of epulis fissuratum and frenulum
Who cannot join
- Pregnancy, lactation, and taking contraceptive pills; being allergic to the drug or other NSAIDs to be used in the study; had used steroids or analgesic drugs for any reason for the last 1 month; using psychiatric drugs; those with incomplete data and refused to sign the consent form; those who were extremely afraid and had a gag reflex; those with any gastrointesinal problems; smoking, ASA-2 and ASA-3 patients and those who smoked.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Flurbiprofen Tablet and Spray For Postoperative Pain Control In Oral Soft Tissue Wounds: A Randomized Clinical Trial
The amount of active ingredient in tablet form of flurbiprofen is higher than that in the oral spray form. Therefore, based on the hypothesis that the side effects that may occur depending on the dose can be reduced, this clinical study investigated whether tablet and spray form flurbiprofen would have similar effects on postoperative pain in primarily closed soft tissue wounds in the oral region.
Read the detailed description
In line with the number of patients obtained after sample size calculation, the study was completed on 40 patients who met the inclusion criteria. Patients were healthy, volunteer individuals who required excision of the epulis fissuratum or frenulum with the indication of preprosthetic surgery. 2 groups were formed by simple randomization with 20 patients in the tablet group and 20 patients in the spray group. After the surgical procedure, tablet and spray flurbiprofen were prescribed according to the groups. Apart from these, paracetamol, chlorhexidine gluconate + benzidamine hydrochloride mouthwash were prescribed to all patients as rescue analgesics. The tissue fragments removed from the patients who underwent epulis excision were sent for histopathologic evaluation and confirmed.
- Conditions
- Oral Soft Tissue Conditions, Drug Effect, Drug Use
- Being tested
- Flurbiprofen
- Keywords
- flurpibrofen, oral soft tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlurbiprofenDrug
Also called Spray flurbiprofen vs Tablet flurbiprofen
The efficacy of two different forms and amounts of active ingredient (100mg tablet vs 25% oral spray) on postoperative pain of different flurbiprofen
| Study group | Role | What they receive |
|---|---|---|
| Spray group | Experimental | Spray group consisted of individuals who used flurbiprofen in spray form as a postoperative analgesic Receives: Drug: Flurbiprofen |
| Tablet group | Active comparator | Tablet group consisted of individuals who used flurbiprofen in tablet form as a postoperative analgesic Receives: Drug: Flurbiprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain evaluation with Numeric Rating Scale scores
The effect of analgesics used in the groups on the level of pain in Numeric Rating Scale (The pain intensity was assessed on a 0-10 ranking scale with 0 representing "no pain" and 10 "most severe pain" ) after soft tissue surgery was investigated.
Measured: One week (3, 6, 24, 48, and 72 hours and on the 5th and 7th days)
Secondary outcomes (1)
Rescue analgesic intake
It was investigated whether rescue analgesics were needed in the groups
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start26 Oct 2023
- Primary completion12 Jan 2024
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Soft Tissue ConditionsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cennet Neslihan Eroglu, Yuzuncu Yil University
- Investigators
- Cennet N Eroglu, DDS,PhD, Principal investigator, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238154
- Sponsor's protocol ID
- 05/25102023
- Status last verified
- Jul 2024
- First submitted
- 24 Jan 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is published, the study information will be shared with the researchers who request it, taking into account the right to protect personal data
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Flurbiprofen Tablet and Spray For Postoperative Pain Control In Oral Soft Tissue Wounds: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06238154
- Acronym / sponsor ID
- 05/25102023
- Conditions
- Oral Soft Tissue Conditions, Drug Effect, Drug Use
- Keywords
- flurpibrofen, oral soft tissue
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 2 Feb 2024 (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 amount of active ingredient in tablet form of flurbiprofen is higher than that in the oral spray form. Therefore, based on the hypothesis that the side effects that may occur depending on the dose can be reduced, this clinical study investigated whether tablet and spray form flurbiprofen would have similar effects on postoperative pain in primarily closed soft tissue wounds in the oral region.
Detailed description
In line with the number of patients obtained after sample size calculation, the study was completed on 40 patients who met the inclusion criteria. Patients were healthy, volunteer individuals who required excision of the epulis fissuratum or frenulum with the indication of preprosthetic surgery. 2 groups were formed by simple randomization with 20 patients in the tablet group and 20 patients in the spray group. After the surgical procedure, tablet and spray flurbiprofen were prescribed according to the groups. Apart from these, paracetamol, chlorhexidine gluconate + benzidamine hydrochloride mouthwash were prescribed to all patients as rescue analgesics. The tissue fragments removed from the patients who underwent epulis excision were sent for histopathologic evaluation and confirmed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spray group | Experimental | Drug: FlurbiprofenSpray group consisted of individuals who used flurbiprofen in spray form as a postoperative analgesic |
| Tablet group | Active comparator | Drug: FlurbiprofenTablet group consisted of individuals who used flurbiprofen in tablet form as a postoperative analgesic |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Provided that those using removable prosthesis had discontinued using the prosthesis 1 month ago (in order to minimize the lesion to be excised), healthy or ASA Class I patients between 40 and 65 years of age, who had the indication of pre-prosthetic surgery due to excision of epulis fissuratum and frenulum
Key exclusion criteria (1 listed)
- Pregnancy, lactation, and taking contraceptive pills; being allergic to the drug or other NSAIDs to be used in the study; had used steroids or analgesic drugs for any reason for the last 1 month; using psychiatric drugs; those with incomplete data and refused to sign the consent form; those who were extremely afraid and had a gag reflex; those with any gastrointesinal problems; smoking, ASA-2 and ASA-3 patients and those who smoked.
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 |
|---|---|---|
| FlurbiprofenAlso: Spray flurbiprofen vs Tablet flurbiprofenThe efficacy of two different forms and amounts of active ingredient (100mg tablet vs 25% oral spray) on postoperative pain of different flurbiprofen | Drug | Spray group, Tablet group |
Primary outcome
Postoperative pain evaluation with Numeric Rating Scale scores
Time frame: One week (3, 6, 24, 48, and 72 hours and on the 5th and 7th days)
The effect of analgesics used in the groups on the level of pain in Numeric Rating Scale (The pain intensity was assessed on a 0-10 ranking scale with 0 representing "no pain" and 10 "most severe pain" ) after soft tissue surgery was investigated.
1 secondary outcome
Rescue analgesic intake
Time frame: One week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: Yes. After the study is published, the study information will be shared with the researchers who request it, taking into account the right to protect personal data
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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.
Cennet N Eroglu, DDS,PhD principal investigator
Yuzuncu Yil University
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 Flurbiprofen in people with Oral Soft Tissue Conditions and Drug Effect, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Jul 2024. 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 Turkey (Türkiye). 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative pain evaluation with Numeric Rating Scale scores (time frame: One week (3, 6, 24, 48, and 72 hours and on the 5th and 7th days)). 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 26 Jul 2024.