Oral Flurbiprofen Spray for Mucosal Graft Harvesting at the Palatal Area
1 other identifier
interventional
48
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started May 2016
Shorter than P25 for early_phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 21, 2017
CompletedFirst Posted
Study publicly available on registry
May 24, 2017
CompletedMay 24, 2017
May 1, 2017
9 months
May 21, 2017
May 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
complete epithelization
the time needed to obtain complete epithelization of the palatal wounds
2 months postoperatively
Secondary Outcomes (4)
patients' discomfort
2 months postoperatively
postoperative swelling
2 months postoperatively
changes in patients' feeding habits
2 months postoperatively
burning sensation
2 months postoperatively
Study Arms (4)
flurbiprofen-free gingival graft
ACTIVE COMPARATORplacebo-free gingival graft
PLACEBO COMPARATORflurbiprofen-connective tissue graft
ACTIVE COMPARATORplacebo-connective tissue graft
PLACEBO COMPARATORInterventions
oral flurbiprofen spray
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- hypersensitivity to flurbiprofen,
- history of allergy to NSAIDs,
- having coagulation disorders,
- presence of gagging reflex.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gazi Universitylead
Related Publications (1)
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.
PMID: 30007054DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
May 21, 2017
First Posted
May 24, 2017
Study Start
May 1, 2016
Primary Completion
February 1, 2017
Study Completion
March 1, 2017
Last Updated
May 24, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share