Oral Flurbiprofen Spray for Mucosal Graft Harvesting at the Palatal Area

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.

Study Overview

• Status: Completed
• Conditions: Surgery, Oral
• Intervention / Treatment: Drug: Flurbiprofen; Drug: placebo

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. hypersensitivity to flurbiprofen,
2. history of allergy to NSAIDs,
3. having coagulation disorders,
4. presence of gagging reflex.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: flurbiprofen-free gingival graft	Drug: Flurbiprofen; oral flurbiprofen spray
Placebo Comparator: placebo-free gingival graft	Drug: placebo; oral placebo spray
Active Comparator: flurbiprofen-connective tissue graft	Drug: Flurbiprofen; oral flurbiprofen spray
Placebo Comparator: placebo-connective tissue graft	Drug: placebo; oral placebo spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete epithelization	the time needed to obtain complete epithelization of the palatal wounds	2 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patients' discomfort	Visual Analogue Scale (VAS)	2 months postoperatively
postoperative swelling	Visual Analogue Scale (VAS)	2 months postoperatively
changes in patients' feeding habits	Visual Analogue Scale (VAS)	2 months postoperatively
burning sensation	Visual Analogue Scale (VAS)	2 months postoperatively

Collaborators and Investigators

• Sponsor: Gazi University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: May 21, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): May 24, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: free gingival grafts; flurbiprofen; connective tissue grafts
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Flurbiprofen
• Other Study ID Numbers: 36290600/66

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No