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Surgery, OralEarly Phase 1NCT03165929

Oral Flurbiprofen Spray for Mucosal Graft Harvesting at the Palatal Area

A Early Phase 1 study testing Flurbiprofen in people with Surgery, Oral, run by Gazi University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Connective tissue graft (CTG) and free gingival graft (FGG) harvesting from the palatal area has been used frequently in the periodontal mucogingival surgery and reported to provide higher predictability and success regarding esthetic outcomes. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Surgery, Oral
What is being tested?
Flurbiprofen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
No sites listed yet
Study dates
May 2016to Mar 2017
Phase
Early Phase 1
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 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • age > 18 years,
  • not having any systemic disease that could compromise wound healing,
  • no periodontal surgery on the experimental sites before,
  • no smoking,
  • no pregnancy or lactation.

Who cannot join

  • hypersensitivity to flurbiprofen,
  • history of allergy to NSAIDs,
  • having coagulation disorders,
  • presence of gagging reflex.

About this study

Official title: Oral Flurbiprofen Spray for Mucosal Graft Harvesting at the Palatal Area: A Randomized Placebo-controlled Study

Connective tissue graft (CTG) and free gingival graft (FGG) harvesting from the palatal area has been used frequently in the periodontal mucogingival surgery and reported to provide higher predictability and success regarding esthetic outcomes. The aim of the study was to evaluate the effects of oral flurbiprofen spray on wound healing, postoperative patient morbidity and discomfort after palatal graft harvesting.

Forty eight patients scheduled for CTG and FGG requiring periodontal plastic surgeries were selected. The patients were randomly assigned to each group, and used oral spray of flurbiprofen or placebo 3 times a day for a week. The palatal donor area was evaluated at 1 and 3 days and 1, 2, 3, 4, 6 and 8 weeks postsurgery for postoperative pain, complete epithelization, feeding habits, color match, and total number of analgesic pills taken. The Wound-Healing Index (WHI) was recorded at 2-week follow up.

Read the detailed description

The palatal area, which is mostly used for connective tissue graft (SCTG) and free gingival graft (FGG) harvesting, usually provides sufficient donor tissue for periodontal plastic surgery. Surgical techniques using these procedures have been reported to present higher predictability and long term stability regarding root coverage, keratinized tissue width and soft tissue thickness increase.

Graft harvesting from the palatal area has been suggested to have some complications in the literature. Excessive hemorrhage, prolonged severe pain or discomfort, infection or necrosis of palatal tissue have been reported to occur post-operatively. To prevent these postoperative complications in the donor sites, hemostatic dressing, bioactive materials such as collagen membranes and platelet concentrates, biostimulant procedures such as low-level laser therapy and chemotherapeutic agents have been suggested. However, there is no consensus about which procedure is more efficient to reduce post-operative symptoms and to enhance early wound healing after palatal graft harvesting.

Non-steroidal anti-inflammatory drugs (NSAIDs) are the analgesic agents which widely used for the treatment of inflammation and pain management. Flurbiprofen, a chiral NSAID of the 2-arylpropionic acid class, inhibits cyclooxygenase-1 and -2 resulting in the reduced formation of prostaglandins, thromboxanes, and prostacyclin, with gastrointestinal tolerance considered better than aspirin and indomethacin, and comparable to ibuprofen and naproxen. It has been shown to possess an adequate analgesic/anti-inflammatory activity in rheumatology, gynecology, obstetrics, and oncology.

Epidemiologic studies demonstrated that systemic administration of NSAIDs commonly associated with side effects related to the gastrointestinal and renal systems. To limit the systemic exposure to oral NSAIDs and to maximize drug levels at the site of affected area, topical NSAIDs have been suggested to use. Topical flurbiprofen was reported to decrease corneal sensitivity, to effect symptomatic relief of sore throat and to reduce acute post-operative pain after oral surgical procedures in previous studies. An oral spray formulation containing 0.075 g of flurbiprofen per 30 ml spray has been developed and frequently use for the inflammatory affections of the oral cavity, pharynx and larynx.

The hypotheses for this study were that flurbiprofen spray could accelerate wound healing and reduce the patient discomfort. Therefore, the objective of the present study was to assess clinical efficacy of flurbiprofen spray on early wound healing and patient morbidity at both FGG and SCTG palatal donor sites.

Conditions
Surgery, Oral
Being tested
Flurbiprofen, placebo
Keywords
free gingival grafts, connective tissue grafts, flurbiprofen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FlurbiprofenDrug

    oral flurbiprofen spray

  • placeboDrug

    oral placebo spray

Study groups in NCT03165929
Study groupRoleWhat they receive
flurbiprofen-free gingival graftActive comparatorNot described
Receives: Drug: Flurbiprofen
placebo-free gingival graftPlacebo comparatorNot described
Receives: Drug: placebo
flurbiprofen-connective tissue graftActive comparatorNot described
Receives: Drug: Flurbiprofen
placebo-connective tissue graftPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. complete epithelization

    the time needed to obtain complete epithelization of the palatal wounds

    Measured: 2 months postoperatively

Secondary outcomes (4)
  1. patients' discomfort

    Visual Analogue Scale (VAS)

    Measured: 2 months postoperatively

  2. postoperative swelling

    Visual Analogue Scale (VAS)

    Measured: 2 months postoperatively

  3. changes in patients' feeding habits

    Visual Analogue Scale (VAS)

    Measured: 2 months postoperatively

  4. burning sensation

    Visual Analogue Scale (VAS)

    Measured: 2 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2017
  2. Study startMay 2016
  3. Primary completionFeb 2017
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03165929
Sponsor's protocol ID
36290600/66
Status last verified
May 2017
First submitted
21 May 2017
Last updated
24 May 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Isler SC, Eraydin N, Akkale H, Ozdemir B. Oral flurbiprofen spray for mucosal graft harvesting at the palatal area: A randomized placebo-controlled study. J Periodontol. 2018 Oct;89(10):1174-1183. doi: 10.1002/JPER.17-0381. Epub 2018 Aug 29.

    PubMed 30007054

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Flurbiprofen in people with Surgery, Oral, run by Gazi University.

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 5 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: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

complete epithelization (time frame: 2 months postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03165929, which also lists 1 linked publication.

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 24 May 2017.

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