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The goal of this randomized clinical trial is to compare whether soft tissue augmentation placed in the donor site following a gum graft harvesting leads to volumetric changes compared to non-augmented sites in the palate. The main questions it aims to answer are:
Researchers will compare non-augmented sites with augmented sites to see if there is a change in tissue thickness and volume.
The randomized controlled trial aims to investigate the potential effect of post-harvesting donor site augmentation on palatal volumetric changes following connective tissue graft harvesting.
The study investigation is a randomized controlled trial (RCT) that aims to have 20 participants in each group. The palatal thickness will be clinically assessed and a digital intraoral scan of the palate will be performed pre-operatively. A subepithelial connect tissue graft will then be harvested from the palate. Patients will then be randomly assigned to receive/not receive augmentation of the donor site, using a collagen sponge. Palatal thickness measurements and intraoral scans will be repeated at 2-, 4-, and 6-months postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Individuals with no addition of intervention (collagen matrix) after harvesting from the palate for a subepithelial connective tissue graft. | |
| Collagen Matrix | Experimental | Individuals with the addition of the intervention (collagen matrix) after harvesting form the palate for a subepithelial connective tissue graft. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of collagen matrix after subepithelial connective tissue graft harvest | Device | A collagen matrix is placed under the overlying flap after the subepithelial connective tissue graft harvesting. |
| Measure | Description | Time Frame |
|---|---|---|
| Palatal Thickness Change | Initial palatal thickness of first and second surgery will be measured prior to each surgical incision with an endodontic reamer | 2 months, 4 months, 6 months |
| Palatal Volume Change | Palatal volume change will be compared using an intraoral scan where the scans will be overlayed to compare differences is volume change. | 2 months, 4 months, 6 months |
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Inclusion Criteria:
Demographic
Medical History
Dental history
Other
Exclusion Criteria:
i. Medical History
Dental
Patients with any history of palatal surgery
Patients with inadequate donor site anatomy
Poor oral hygiene
Untreated periodontitis
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying S Wang, DDS, MS | Contact | (214) 828-8282 | yswang@tamu.edu | |
| Hailey Bivens, DDS | Contact | heb2025@tamu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ying S Wang, DDS, MS | Texas A&M School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas A&M College of Dentistry | Recruiting | Dallas | Texas | 75226 | United States |
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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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Individuals will be randomly assigned to be in the control group of the intervention group (Collagen matrix soft tissue augmentation).
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Individuals computing the statistical analysis will be masked for which outcome was used. Surgeons and patients will only know which outcome will be used at time of surgery.
|
| D055093 |
| Periodontal Atrophy |