Donor Site Complication
Conditions
Brief summary
CTG was harvested from 21 patients in each group. Donor site was treated with either GS (control) or GS+CY (test). Palatal tissue thickness, graft dimensions, working time (WT) and primary bleeding time were recorded intraoperatively. The data of pain perception (PP) will be measured using visual analog scale, quantity of analgesics (QA), secondary bleeding (SB), epithelization level (EL), and color match (CM) will be assessed prospectively. these outcomes will be evaluated in the first 7 days and 14th, 21th, and 28th days. Patient reported outcomes will be recorded using OHIB 14 questionnaire.
Interventions
DRUGGelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT]
Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group)
Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group) and GS covered with high viscosity CY (PeriAcryl®, Glustitch Inc., Delta, Canada) (GS+CY group).
Sponsors
Hacettepe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
One author (H.G.K.) randomly assigned the patients, with 1:1 allocation ratio, into GS and GS+CY groups by making simple randomization without blocking (computer-generated randomization scheme) (Figure 1). Number-labeled opaque envelopes containing the name of assigned method were used for allocation concealment. The surgical procedures were carried out by (B.T.Y.) whereas another author (E.C.) acquired the intra- and post-operative data. No information regarding to the applied hemostatic was given to the patients to preserve the patient blinding.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* age ≥18; * PPS indication that needs CTG in 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 surgical site; * systemic disease; * pregnancy; * use of medications with potential adverse effects to periodontal tissues
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Donor site pain perception (PP) | first week | Patients score their daily donor site pain perception (PP) level by giving numbers from 0 to 10 according to the visual analog scale (VAS) (0: no pain, 1: minimal pain, 10: severe pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary bleeding (SB) | first week | Patients recorded presence/absence of secondary bleeding (SB) (yes or no). |
| Primary bleeding time (PBT) | during surgery | Immediately after harvesting, sterile gauze was compressed to the palatal wound for 2 minutes, blood wiped once in every 30 seconds until bleeding stops. The duration was recorded as primary bleeding time (PBT). |
| Graft height (GH) | during surgery | Dimensions were measured with periodontal probe |
| Graft width (GW) | during surgery | Dimensions were measured with periodontal probe |
| Quantity of analgesics (QA) | first week | Patients recorded the quantity of analgesics (QA) taken |
| Working time (WT) | during surgery | Harvesting process was recorded |
| Sensation loss (SL) | first week, second week , third week, fourth week. | Sensation loss (SL) was scored as none, medium or severe |
| Color match (CM) | first week, second week, third week, fourth week. | Color match (CM) with the adjacent tissue was determined by using a VAS scale (0: absence of harmony, 10: excellent harmony) |
| Epithelization level (EL) | first week, second week, third week, fourth week. | Epithelization level (EL) was scored as none, partial or full epithelization by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface following surgery |
| Graft thickness (GT) | during surgery | Dimensions were measured with periodontal probe |
Countries
Turkey (Türkiye)
Outcome results
None listed