Oral Flurbiprofen Spray for Mucosal Graft Harvesting at the Palatal Area
Condition: Surgery, Oral
Study type: Interventional
Phase: Early Phase 1

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. 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.
    

Intervention name(s): Flurbiprofen; placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral flurbiprofen spray; oral placebo spray
Intervention MeSH terms: Flurbiprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: free gingival grafts; connective tissue grafts; flurbiprofen