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| Name | Class |
|---|---|
| American Academy of Periodontology Foundation | UNKNOWN |
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The purpose of this study is to quantitatively investigate the radiographic changes of alveolar bone, and gingival tissue changes of the mandibular anterior teeth in experimental group A receiving SFOT using freeze-dried allograft with a collagen membrane, experimental group B receiving SFOT using particulate xenograft covered by a collagen membrane and control group receiving only orthodontics therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
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| Group B | Experimental |
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| Control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgically facilitated orthodontics therapy (SFOT) using allograft | Device | Participants will receive Surgically facilitated orthodontics therapy (SFOT) along with bone grafting using particulate allograft and collagen membrane, prior to orthodontics treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in horizontal bone thickness at the 3mm point from Cementoenamel junction (CEJ) (crestal level) on the mandibular incisors | from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment) | |
| Change in horizontal bone thickness at the 6mm point from CEJ (middle level) on the mandibular incisors | from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment) | |
| Change in horizontal bone thickness at the 9mm point from CEJ (apical level) on the mandibular incisors | from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment) | |
| Change in volume of three dimensional bone | from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment) | |
| Change in volume of three dimensional soft tissue | from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in vertical bone level (VBL)from the CEJ | Baseline, at alignment (approximately 4 months after the start of orthodontics treatment). | |
| Change in probing depth (PD) | PD is the distance from CEJ to base of gingival pocket |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sahar Dowlatshahi, DDS, MMSc | Contact | (713) 486-4074 | Sahar.Dowlatshahi@uth.tmc.edu | |
| Nikola Angelov | Contact | (713) 486-4073 | Nikola.Angelov@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sahar Dowlatshahi, DDS, MMSc | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77479 | United States |
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| Surgically facilitated orthodontics therapy (SFOT) using xenograft | Device | Participants will receive SFOT using particulate xenograft and collagen membrane, prior to orthodontics treatment. |
|
| Usual care | Device | Participants will have conventional orthodontics treatment with Invisalign aligners, without any surgical intervention |
|
| Baseline, at alignment (approximately 4 months after the start of orthodontics treatment). |
| Change in clinical attachment level (CAL) | CAL is the distance between CEJ and base of the pocket | Baseline, at alignment (approximately 4 months after the start of orthodontics treatment). |
| Change in width of keratinized tissue (WKT) at alignment | Baseline, at alignment (approximately 4 months after the start of orthodontics treatment). |
| ID | Term |
|---|---|
| D008311 | Malocclusion, Angle Class I |
| ID | Term |
|---|---|
| D008310 | Malocclusion |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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