Wound Heal
Conditions
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 and cyanoacrylate or a collagen sponge, cyanoacrylate, and suspending sutures. 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.
Interventions
The donor site will be closed both with gelatin sponge +Cyanoacrylate (Spongostan®, Ethicon, USA)+ supporting sutures (control group)
PROCEDUREGelatin sponge stabilization with cyanoacrylate
Seconder The donor site will be closed both with gelatin sponge +Cyanoacrylate (Spongostan®, USA) (test group)
Sponsors
Hacettepe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Donor site pain perception | 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 | during first week | Patients will record presence or absence of secondary bleeding (presence=1 or absence=0). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft thickness | during surgery | Dimensions will be measured during surgery by clinician using Michigan O probe (will be reported in mm) |
| Working time | during surgery | Harvesting process will be recorded by an blinded research assistant |
| Quantity of analgesics | first week | Patients recorded the quantity of analgesics taken will be reported as quantity of pill |
| Graft height | during surgery | Dimensions will be measured during surgery by clinician using Michigan O probe (will be reported in mm) |
| Color match | first week, second week, third week, fourth week. | Color match with the adjacent tissue was determined by researcher using a Visual Analog Pain Scale scale (0: absence of harmony, 10: excellent harmony) |
| Epithelization level | first week, second week, third week, fourth week. | Epithelization level was scored by researcher as none, partial or full epithelization by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. |
| The Oral Health Impact Profile-14 is a questionnaire that measures how oral disorders impact a patient's quality of life. | first week | The questionnaire has 14 items with answers rated on a 5-point Likert scale (from 1 = never to 5 = very often) to indicate a level of different problems related to oral health |
| Sensation loss | first week, second week , third week, fourth week. | Sensation loss will be scored by the help of clinician comparing with the symmetrical side an will be recorded as no-loss, medium loss or severe loss |
| Graft width | during surgery | Dimensions will be measured during surgery by clinician using Michigan O probe.(will be reported in mm) |
Countries
Turkey (Türkiye)
Outcome results
None listed