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| Name | Class |
|---|---|
| Tufts University School of Dental Medicine | OTHER |
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The purpose of this study is to evaluate Omega-3 Woundâ„¢ as an alternative to autogenous free gingival grafts harvested from the palate to treat human subjects with insufficient KT (< 2 mm)
Primary objective:
The primary aim will be to see if Omega-3 Woundâ„¢ is clinically superior to tissue harvested from the palate (Autogenous Free Gingival Graft) when comparing before and after measurements of: keratinized tissue. Change in KT width from time of surgery to 6 months post-surgery (22).
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kerecis Oral™ | Experimental | The Fish Skin Graft will be is cut to shape of wound bed and placed directly on the appropriate prepared recipient wound bed. The Fish skin graft has the smooth side down and the scaly side facing out. The graft will be sutured in place at either coronal end with resorbable sutures and may be secured apically if needed. A surgical dressing (Coe-Pak® ) will be placed over the graft if needed. |
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| Autogenous Free Gingival Graft | Active Comparator | The recipient bed will be prepared at the appropriate sequential time as described. The graft will be harvested from the same side that the Free Gingival Graft is to be placed. A measurement will be made to determine the size of the donor tissue needed to be placed at the recipient site. Local anesthetic will be administered. The donor tissue will be harvested using the usual techniques. The width will be 5 mm and the length will match the predetermined measurement. The graft will be thinned as is usual practice. The harvested palatal graft will be centered on the study tooth and placed on the appropriately prepared recipient wound bed. The graft will be sutured with resorbable sutures on the mesial and distal aspects of the tooth. A surgical dressing (Coe-Pak® ) will be placed over the graft if needed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kerecis Oralâ„¢ | Device |
|
| |
| Free Gingival Graft |
| Measure | Description | Time Frame |
|---|---|---|
| Change in KT width from time of surgery to 3 months post-surgery | Increase in KT Width in MM | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Probing depth | mm | 3 months |
| Papillary height and widht | mm | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadeem Karimbux, DMD, MMSc | Tufts University of Dental Medicine | Study Chair |
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Prospective, randomized controlled, split mouth (within subject) non-inferiority, single-center trial.
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| Other |
A free gingival autograft from patient palate placed and secured on wound bed |
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| Horizontal recession |
mm |
| 3 months |
| Subject completed discomfort questionaire | Standard questionare | 3 months |
| Bleeding on probing | Y/N | 3 months |