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.
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 group | Role | What they receive |
|---|---|---|
| flurbiprofen-free gingival graft | Active comparator | Not described Receives: Drug: Flurbiprofen |
| placebo-free gingival graft | Placebo comparator | Not described Receives: Drug: placebo |
| flurbiprofen-connective tissue graft | Active comparator | Not described Receives: Drug: Flurbiprofen |
| placebo-connective tissue graft | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete epithelization
the time needed to obtain complete epithelization of the palatal wounds
Measured: 2 months postoperatively
Secondary outcomes (4)
patients' discomfort
Visual Analogue Scale (VAS)
Measured: 2 months postoperatively
postoperative swelling
Visual Analogue Scale (VAS)
Measured: 2 months postoperatively
changes in patients' feeding habits
Visual Analogue Scale (VAS)
Measured: 2 months postoperatively
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.
- First posted24 May 2017
- Study startMay 2016
- Primary completionFeb 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgery, OralStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sıla Çağrı İşler, Gazi University
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
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Flurbiprofen Spray for Mucosal Graft Harvesting at the Palatal Area: A Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT03165929
- Acronym / sponsor ID
- 36290600/66
- Conditions
- Surgery, Oral
- Keywords
- free gingival grafts, connective tissue grafts, flurbiprofen
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 24 May 2017 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| flurbiprofen-free gingival graft | Active comparator | Drug: Flurbiprofen |
| placebo-free gingival graft | Placebo comparator | Drug: placebo |
| flurbiprofen-connective tissue graft | Active comparator | Drug: Flurbiprofen |
| placebo-connective tissue graft | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- hypersensitivity to flurbiprofen,
- history of allergy to NSAIDs,
- having coagulation disorders,
- presence of gagging reflex.
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 |
|---|---|---|
| Flurbiprofenoral flurbiprofen spray | Drug | flurbiprofen-connective tissue graft, flurbiprofen-free gingival graft |
| placebooral placebo spray | Drug | placebo-connective tissue graft, placebo-free gingival graft |
Primary outcome
complete epithelization
Time frame: 2 months postoperatively
the time needed to obtain complete epithelization of the palatal wounds
4 secondary outcomes
patients' discomfort
Time frame: 2 months postoperatively
postoperative swelling
Time frame: 2 months postoperatively
changes in patients' feeding habits
Time frame: 2 months postoperatively
burning sensation
Time frame: 2 months postoperatively
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 24 May 2017.
- Derived from this study: PubMed 30007054Isler 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.
- Individual participant dataSharing planned: No
Related trials for Surgery, Oral
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
Not yet recruitingPhase 2
Effectiveness of Oxitard Gel Versus Physiotherapeutic and Pharmacological Interventions in Alleviating Oral Submucous Fibrosis: A Phase-II Randomized Control Trial
Oral and Maxillofacial Conditions
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
The record lists no contact. Use the official record to reach the sponsor.
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.