The Effect of Two Different Approaches on Palatal Donor Site Management After De-epithelialized Graft Harvesting: Randomized Clinical Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Wound Heal
- Sponsor
- Medipol University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Donor site pain perception
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
An epithelialized gingival graft will be harvested from the palate for the treatment of various mucogingival deformities. The donor site will be treated with either a combination of a collagen sponge, cyanoacrylate and suspending sutures or a collagen sponge, cyanoacrylate, suspending sutures and coconut oil.
Detailed Description
After epithelialized gingival graft harvesting, intraoperatively, measurements will be taken for palatal tissue thickness, graft dimensions, working time, and primary bleeding time. Data regarding pain perception will be gauged using a visual analog scale, and the number of analgesics, secondary bleeding, epithelization level, and color match will be assessed prospectively. These outcomes will be evaluated on the first 7 days and subsequently on the 14th, 21st, and 28th days. Patient-reported outcomes will be recorded using the Oral Health Impact Profile-14 questionnaire.
Investigators
Melis Yilmaz
DDs, PhD
Medipol University
Eligibility Criteria
Inclusion Criteria
- •age ≥18; mucogingival surgical treatment indication that needs connective tissue graft in the anterior mandible; stable periodontium after phase I therapy; full-mouth plaque and bleeding scores \<15%
Exclusion Criteria
- •previous palatal harvesting history; unstable endodontic conditions; tooth mobility at the surgical site; systemic disease; pregnancy; use of medications with potential adverse effects on periodontal tissues
Outcomes
Primary Outcomes
Donor site pain perception
Time Frame: everyday in first week
Patients score their daily donor site pain perception using visual analog score level by giving numbers from 0 to 10 according to the visual analog scale (0: no pain, 1: minimal pain, 10: severe pain)
Secondary bleeding time
Time Frame: during first week
Patients will record presence or absence of secondary bleeding (presence=1 or absence=0).
Secondary Outcomes
- Graft height(during surgery)
- Graft width(during surgery)
- Graft thickness(during surgery)
- Working time(during surgery)
- Quantity of analgesics(first week)
- Sensation loss(first week, second week , third week, fourth week.)
- Color match(first week, second week, third week, fourth week.)
- Epithelization level(first week, second week, third week, fourth week.)
- The Oral Health Impact Profile-14 is a questionnaire that measures how oral disorders impact a patient's quality of life.(first week)