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OpenTrials
Completed

NCT Number: NCT06238154

Flurbiprofen Tablet vs Spray In Oral Soft Tissue Wounds

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yuzuncu Yil University

Van, Merkez, 65090, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Spray flurbiprofen vs Tablet flurbiprofen

Primary outcomes

  1. 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.

Secondary outcomes

  1. Rescue analgesic intake

    Time frame: One week

    It was investigated whether rescue analgesics were needed in the groups

Other outcomes

  1. Drug intake amounts

    Time frame: One week

    Assessment of daily analgesic requirement in groups

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

Assessment of Flurbiprofen Tablet and Spray For Postoperative Pain Control In Oral Soft Tissue Wounds: A Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 2, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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