Flurbiprofen Tablet vs Spray In Oral Soft Tissue Wounds | NCT06238154

Studies
Flurbiprofen Tablet vs Spray In Oral Soft Tissue Wounds

NCT06238154

Sponsor

Yuzuncu Yil University

Status

Completed

Last Update Posted

Jul 26, 2024Actual

Enrollment

40Actual

Phase

Phase 4

Conditions

Oral Soft Tissue Conditions
Drug Effect
Drug Use

Interventions

Flurbiprofen

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 26, 2023Actual

Primary Completion Date

Jan 12, 2024Actual

Completion Date

Jan 20, 2024Actual

First Submitted Date

Jan 24, 2024

First Submission Date that Met QC Criteria

Feb 1, 2024

First Posted Date

Feb 2, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2024

Last Update Posted Date

Jul 26, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Spray group	Experimental	Spray group consisted of individuals who used flurbiprofen in spray form as a postoperative analgesic	Drug: Flurbiprofen
Tablet group	Active Comparator	Tablet group consisted of individuals who used flurbiprofen in tablet form as a postoperative analgesic	Drug: Flurbiprofen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Flurbiprofen	Drug	The efficacy of two different forms and amounts of active ingredient (100mg tablet vs 25% oral spray) on postoperative pain of different flurbiprofen	Spray group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	One week (3, 6, 24, 48, and 72 hours and on the 5th and 7th days)

Secondary Outcomes

Measure	Description	Time Frame
Rescue analgesic intake	It was investigated whether rescue analgesics were needed in the groups	One week

Other Outcomes

Measure	Description	Time Frame
Drug intake amounts	Assessment of daily analgesic requirement in groups	One week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cennet N Eroglu, DDS,PhD	Yuzuncu Yil University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yuzuncu Yil University		Van	Merkez	65090	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

IPD and documents will be available for sharing 1 year after publication for a period of 2 years. Access to the IPD and documents will be open on the IPDShare website with registration. The information will be freely available and can be used for any purpose. There will not be any review process or no Data Use Agreement will be necessary.

Access Criteria

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005480	Flurbiprofen

Ancestor Terms

ID	Term
D011422	Propionates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

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