NCT06238154

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

January 24, 2024

Last Update Submit

July 24, 2024

Conditions

Oral Soft Tissue ConditionsDrug EffectDrug Use

Keywords

flurpibrofenoral soft tissue

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Rescue analgesic intake

    One week

Other Outcomes (1)

  • Drug intake amounts

    One week

Study Arms (2)

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

FlurbiprofenDRUG

The efficacy of two different forms and amounts of active ingredient (100mg tablet vs 25% oral spray) on postoperative pain of different flurbiprofen

Also known as: Spray flurbiprofen vs Tablet flurbiprofen
Spray groupTablet group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuzuncu Yil University

Van, Merkez, 65090, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Flurbiprofen

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Cennet N Eroglu, DDS,PhD

    Yuzuncu Yil University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The clinician collecting data from patients was blinded. The researcher who analyzed the results was blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof Dr

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 2, 2024

Study Start

October 26, 2023

Primary Completion

January 12, 2024

Study Completion

January 20, 2024

Last Updated

July 26, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF, 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
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.

Locations

TU(1)