Effect of Topically-Applied Hyaluronic-Acid on Palatal Epithelial Wound Closure
NCT ID: NCT02534415
Last Updated: 2015-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
36 participants
INTERVENTIONAL
2013-08-31
2015-08-31
Brief Summary
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Detailed Description
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Primary outcome variables that pain and burning sensation changes were assessed at 3, 7, 14, 21 days after surgery by the examiner. Pain and burning sensation were assessed by patients using the VAS, score 0 indicate no pain or burning sensation, score 10 indicate severe pain or burning sensation. Secondary outcome variables included color match, consistency and epithelization of the wound area. These parameters were assessed by the same examiner at 3, 7, 14, 21 and 42 days after surgery. Color of the palatal mucosa was assessed by comparing it to that of the adjacent and opposite site using the VAS. Score 0 indicate no color match and score 10 indicate very good color match. Consistency of the palatal mucosa was assessed with a blunt instrumentation and scored as soft or firm. Epithelialization was scored clinically as none, partial or complete.
Sample size has been estimated in 12 subjects per treatment groups. Random allocation of the treatment sites to test and control groups will be performed using a computerized selection of random numbers for allocation of the study groups.
Clinical images obtained at baseline, 3, 7, 14, 21 and 42 days after surgery from each treatment site.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Periodontal dressing material
Palatal wound area was covered with periodontal dressing material at baseline and 3rd day
Periodontal dressing material
Procedure:Palatal wound area was covered with periodontal dressing material at baseline and 3rd day
0.2% Hyaluronic acid gel
0.2% topical hyaluronic-acid gel was applied to palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day
0.2% Hyaluronic acid gel
0.2% topical hyaluronic-acid gel was applied to palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day
0.8% Hyaluronic acid gel
0.8% topical hyaluronic-acid gel was applied palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day
0.8% Hyaluronic acid gel
0.8% topical hyaluronic-acid gel was applied palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day
Interventions
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Periodontal dressing material
Procedure:Palatal wound area was covered with periodontal dressing material at baseline and 3rd day
0.2% Hyaluronic acid gel
0.2% topical hyaluronic-acid gel was applied to palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day
0.8% Hyaluronic acid gel
0.8% topical hyaluronic-acid gel was applied palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No periodontal surgical treatment in the previous 6 months on the involved sites
Exclusion Criteria
* Patients with a pregnancy or lactation period
* Self-reported history of antibiotic medication within three months
* Absence of tooth in the area of donor site
18 Years
ALL
Yes
Sponsors
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Marmara University
OTHER
Responsible Party
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Principal Investigators
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Bahar Kuru, Prof. Dr.
Role: STUDY_DIRECTOR
Marmara University, Faculty of Denistry, Department of Periodontology
Başak Doğan, Prof. Dr.
Role: STUDY_CHAIR
Marmara University, Faculty of Denistry, Department of Periodontology
Hatice Selin Yıldırım, Dr.
Role: PRINCIPAL_INVESTIGATOR
Marmara University, Faculty of Denistry, Department of Periodontology
Other Identifiers
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YU-351
Identifier Type: -
Identifier Source: org_study_id
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