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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gelatin Sponge | Active Comparator | The palatal wound will be protected with an absorbable gelatin sponge, which will be stabilized by non-resorbable sling sutures. |
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| Collagen Sponge | Experimental | The palatal wound will be protected with a collagen sponge, which will be stabilized by non-resorbable sling sutures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palatal soft tissue graft harvesting | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | 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). | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain | using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable) | at day 1 |
| postoperative pain | using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weida Li, master | Contact | 0571-87219287 | kyb@zjkq.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Peihui Ding, Doctor | The Affiliated Stomatology Hospital of Zhejiang University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Stomatology Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| at 2 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. | 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. | at 1 month |
| at day 3 |
| postoperative pain | using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable) | 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? | at 1 week |
| willingness to repeat the treatment | using a VAS ranging from 0 to 10 (0 = strong unwilling and 10 = strong willing) | at 1 week |
| the existence of delayed bleeding | the occurrence of prolonged hemorrhaging during the first week | 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). | 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). | at 1 month |
| D055093 |
| Periodontal Atrophy |