Wound Healing Complication
Conditions
Keywords
Antiinflammatory, Gingiva, Hyaluronic acid, Palate, Transplants, Wound healing
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.
Interventions
DRUGPeriodontal dressing material
Procedure: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
DRUG0.8% 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
Sponsors
Marmara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 21 days | Using a visual analog scale (0: No pain, 10: Severe pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Burning Sensation | 21 days | Using a visual analog scale (0: No burning sensation, 10: Severe burning sensation) |
| Color match | 42 days | Using a visual analog scale (0: No color match, 10: Good color match) (Adjacent and opposite site) |
| Consistency | 42 days | Soft/firm |
| Epithelialisation | 42 days | None/partial/complete |
Outcome results
None listed