The aim of this study is to compare the efficacy of collagen sponge and gelatin sponge on the palatal wound healing and postoperative pain following gingival graft harvesting.
The aim of this study is to compare the efficacy of collagen sponge and gelatin sponge on the palatal wound healing and postoperative pain following gingival graft harvesting. The included patients will be randomized into two groups. The patients in control group will be treated with gelatin sponge and those in the test group will be treated with collagen sponge. The postoperative pain will be assessed by VAS scale at day 1, 3 and 7 after surgery. Epithelialization of the palatal wound will be evaluated by hydrogen peroxide test and digital photography at 1 week postoperatively. Additionally, postoperative pain, consumption of analgesics, willingness to repeat the treatment and the existence of delayed bleeding will be recorded at 1 week. At 2 weeks, 3 weeks and 1 month after surgery, epithelialization of the palatal wound and aesthetic scores will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
After local anaesthesia, a horizontal incision 2 mm apically from the gingival margin will be carried out using a #15C blade. The standardized rectangular graft with a thickness of 1.5 mm will be harvested from distal aspect of canine till first molar. The graft will be lifted and separated using tissue forceps and a blade till it is free from all sides.
The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGepithelialization of the palatal wound evaluated by hydrogen peroxide test
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
Time frame: at 1 week
epithelialization of the palatal wound evaluated by hydrogen peroxide test
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
Time frame: at 2 weeks
epithelialization of the palatal wound evaluated by hydrogen peroxide test
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
Time frame: at 3 weeks
epithelialization of the palatal wound evaluated by hydrogen peroxide test
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
Time frame: at 1 month
epithelialization of the palatal wound evaluated by digital photography
The epithelialization of the palatal wound will be recorded as "yes" or "no" according to inspectional evaluation of surface characteristics and reflection as well as clarity and distinctness of wound outline.
Time frame: at 1 week
epithelialization of the palatal wound evaluated by digital photography
The epithelialization of the palatal wound will be recorded as "yes" or "no" according to inspectional evaluation of surface characteristics and reflection as well as clarity and distinctness of wound outline.
Time frame: at 2 weeks
epithelialization of the palatal wound evaluated by digital photography
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The epithelialization of the palatal wound will be recorded as "yes" or "no" according to inspectional evaluation of surface characteristics and reflection as well as clarity and distinctness of wound outline.
Time frame: at 3 weeks
epithelialization of the palatal wound evaluated by digital photography
The epithelialization of the palatal wound will be recorded as "yes" or "no" according to inspectional evaluation of surface characteristics and reflection as well as clarity and distinctness of wound outline.
Time frame: at 1 month
postoperative pain
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
Time frame: at day 1
postoperative pain
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
Time frame: at day 3
postoperative pain
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
Time frame: at day 7
consumption of analgesics
to answer the following question: Did you take any analgesics due to the palatal pain since the procedure was completed?
Time frame: at 1 week
willingness to repeat the treatment
using a VAS ranging from 0 to 10 (0 = strong unwilling and 10 = strong willing)
Time frame: at 1 week
the existence of delayed bleeding
the occurrence of prolonged hemorrhaging during the first week
Time frame: at 1 week
aesthetic score
assessed by judging on the color, contour, and texture of the donor sites. The total score will vary between 0 and 6 by scoring each subject from 0 to 2 (0=inharmonious with adjacent tissue, 1=moderately harmonious with adjacent tissue and 2=very harmonious with adjacent tissue).
Time frame: at 3 weeks
aesthetic score
assessed by judging on the color, contour, and texture of the donor sites. The total score will vary between 0 and 6 by scoring each subject from 0 to 2 (0=inharmonious with adjacent tissue, 1=moderately harmonious with adjacent tissue and 2=very harmonious with adjacent tissue).
Time frame: at 1 month