Effect of Topically-Applied Hyaluronic-Acid on Palatal Epithelial Wound Closure
Primary Purpose
Wound Healing Complication
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Periodontal dressing material
0.2% Hyaluronic acid gel
0.8% Hyaluronic acid gel
Sponsored by
About this trial
This is an interventional treatment trial for Wound Healing Complication focused on measuring Antiinflammatory, Gingiva, Hyaluronic acid, Palate, Transplants, Wound healing
Eligibility Criteria
Inclusion Criteria:
- Good general health
- No periodontal surgical treatment in the previous 6 months on the involved sites
Exclusion Criteria:
- Smoking
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Periodontal dressing material
0.2% Hyaluronic acid gel
0.8% Hyaluronic acid gel
Arm Description
Palatal wound area was covered with periodontal dressing material at baseline and 3rd day
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% topical hyaluronic-acid gel was applied palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day
Outcomes
Primary Outcome Measures
Pain
Using a visual analog scale (0: No pain, 10: Severe pain)
Secondary Outcome Measures
Color match
Using a visual analog scale (0: No color match, 10: Good color match) (Adjacent and opposite site)
Consistency
Soft/firm
Epithelialisation
None/partial/complete
Burning Sensation
Using a visual analog scale (0: No burning sensation, 10: Severe burning sensation)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02534415
Brief Title
Effect of Topically-Applied Hyaluronic-Acid on Palatal Epithelial Wound Closure
Official Title
Effect of Topically-Applied Hyaluronic-Acid on Palatal Epithelial Wound Closure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aim of the study is to assess the therapeutic effects of topical hyaluronic-acid use on secondary wound healing of the free gingival graft donor site. The hypothesis of this study is that topical hyaluronic-acid gel has positive effects on secondary wound healing of free gingival graft donor site by reducing pain, burning sensation, and accelerating the healing.
Detailed Description
The objective of the randomized, single blind, controlled and parallel clinical trial was to assess therapeutic effects of topical hyaluronic-acid on secondary wound healing of free gingival graft donor site.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing Complication
Keywords
Antiinflammatory, Gingiva, Hyaluronic acid, Palate, Transplants, Wound healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Periodontal dressing material
Arm Type
Active Comparator
Arm Description
Palatal wound area was covered with periodontal dressing material at baseline and 3rd day
Arm Title
0.2% Hyaluronic acid gel
Arm Type
Experimental
Arm Description
0.2% topical hyaluronic-acid gel was applied to palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day
Arm Title
0.8% Hyaluronic acid gel
Arm Type
Experimental
Arm Description
0.8% topical hyaluronic-acid gel was applied palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day
Intervention Type
Drug
Intervention Name(s)
Periodontal dressing material
Other Intervention Name(s)
Peripac®
Intervention Description
Procedure:Palatal wound area was covered with periodontal dressing material at baseline and 3rd day
Intervention Type
Drug
Intervention Name(s)
0.2% Hyaluronic acid gel
Other Intervention Name(s)
Gengigel
Intervention Description
0.2% topical hyaluronic-acid gel was applied to palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day
Intervention Type
Drug
Intervention Name(s)
0.8% Hyaluronic acid gel
Other Intervention Name(s)
Gengigel
Intervention Description
0.8% topical hyaluronic-acid gel was applied palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day
Primary Outcome Measure Information:
Title
Pain
Description
Using a visual analog scale (0: No pain, 10: Severe pain)
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Color match
Description
Using a visual analog scale (0: No color match, 10: Good color match) (Adjacent and opposite site)
Time Frame
42 days
Title
Consistency
Description
Soft/firm
Time Frame
42 days
Title
Epithelialisation
Description
None/partial/complete
Time Frame
42 days
Title
Burning Sensation
Description
Using a visual analog scale (0: No burning sensation, 10: Severe burning sensation)
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Good general health
No periodontal surgical treatment in the previous 6 months on the involved sites
Exclusion Criteria:
Smoking
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahar Kuru, Prof. Dr.
Organizational Affiliation
Marmara University, Faculty of Denistry, Department of Periodontology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Başak Doğan, Prof. Dr.
Organizational Affiliation
Marmara University, Faculty of Denistry, Department of Periodontology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hatice Selin Yıldırım, Dr.
Organizational Affiliation
Marmara University, Faculty of Denistry, Department of Periodontology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effect of Topically-Applied Hyaluronic-Acid on Palatal Epithelial Wound Closure
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