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| Name | Class |
|---|---|
| CellTherX | INDUSTRY |
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Prospective, randomized, within subjects-controlled design
The objective of this trial is to evaluate clinical healing outcomes of microsurfaced cadaveric ADM (Markman Biologics) used in sites with < 1 mm of attached gingiva requiring soft tissue grafting without root coverage as compared to control cadaveric ADM (AlloDerm, LifeCell) over 180-day post-op period. During the treatment period, each site will be monitored for soft tissue healing and augmentation of keratinized tissue width. All subjects will be seen at post-op day 7, 14, 30, 90, and 180.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-Active | Experimental | Markman Biologics microsurfaced ADM |
|
| B-Control | Active Comparator | AlloDerm ADM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Markman Biologics Microsurfaced ADM | Biological | an ADM which has been scored (microsurfaced) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by color | tissue color | Day 14 post op |
| To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by texture | graft texture assessed as smooth, stippled, rolled, or other and as more firm, equally firm, less firm | Day 14 post op |
| To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by inflammation | tissue inflammation using a score of 0 (normal) to 4 (severe) | Day 14 post op |
| To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by graft failure | graft failure by no evidence of keratinized tissue width | Day 14 post op |
| To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by graft loss | graft loss | Day 14 post op |
| Measure | Description | Time Frame |
|---|---|---|
| Graft Healing | graft healing is assessed by by multiple means | 180 days |
| Clinical Attachment level | change in measured clinical attachment level from baseline to Day 180 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rick Heard, DDS | The McGuire Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perio Health Professionals | Houston | Texas | 77063 | United States |
This is a single site study so data will not be other PIs to share the data with.
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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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| ID | Term |
|---|---|
| C440568 | Alloderm |
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Prospective, randomized, within subjects-controlled design
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| AlloDerm | Biological | AlloDerm tissue matrix |
|
| 180 days |
| Change in Probing depths | change in measurement of probing depth from baseline to Day 180 | 180 days |
| Change in recession | change in measurement of recession from baseline to Day 180 | 180 days |
| Change in keratinized tissue | change in measurement of keratinized from baseline to Day 180 | 180 days |
| Change in gingival attachment | change in measurement of gingival attachment from baseline to Day 180 | 180 days |
| Healing as assessed by histological analysis | analysis by H&E staining of biopsied tissue | 90 days post op |
| Assessment of Infection through 180 days | infection assesse by redness, swelling, pus, fevers, chills | 180 days |
| Occurrence of AEs/SAEs | Adverse events/Serious adverse events reported by site | through 180 days |
| Subject Discomfort | Subject discomfort will be assessed using a single questionnaire containing questions on pain and the need for anti-inflammatory and/or pain meds. | through 180 days |
| D055093 |
| Periodontal Atrophy |