Malocclusion, Angle Class I
Conditions
Keywords
orthodontic treatment
Brief summary
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.
Interventions
DEVICESurgically facilitated orthodontics therapy (SFOT) using allograft
Participants will receive Surgically facilitated orthodontics therapy (SFOT) along with bone grafting using particulate allograft and collagen membrane, prior to orthodontics treatment.
DEVICESurgically facilitated orthodontics therapy (SFOT) using xenograft
Participants will receive SFOT using particulate xenograft and collagen membrane, prior to orthodontics treatment.
DEVICEUsual care
Participants will have conventional orthodontics treatment with Invisalign aligners, without any surgical intervention
Sponsors
American Academy of Periodontology Foundation
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) I/II * Periodontal diagnosis of clinical gingival health or gingivitis on intact/reduced periodontium per 2017 American Academy of Periodontology (AAP) classification * No history of periodontitis. * Class I malocclusion * Crowding of 4 mm or less on mandibular anterior incisors * Incisor mandibular plane angle between 90-100 degrees * No extractions indicated as part of the orthodontic treatment plan * Keratinized tissue of at least 3mm
Exclusion criteria
* Patients who are current smokers * Pregnancy * Uncontrolled diabetes or other metabolic systemic conditions * Presence of open bite or deep bite * Spacing * Excessive retroclined mandibular incisors * Any contraindication to treatment or the material used if in the experimental groups
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in volume of three dimensional bone | from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment) |
| 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 volume of three dimensional soft tissue | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in probing depth (PD) | Baseline, at alignment (approximately 4 months after the start of orthodontics treatment). | PD is the distance from CEJ to base of gingival pocket |
| Change in clinical attachment level (CAL) | Baseline, at alignment (approximately 4 months after the start of orthodontics treatment). | CAL is the distance between CEJ and base of the pocket |
| Change in width of keratinized tissue (WKT) at alignment | Baseline, at alignment (approximately 4 months after the start of orthodontics treatment). | — |
| Change in vertical bone level (VBL)from the CEJ | Baseline, at alignment (approximately 4 months after the start of orthodontics treatment). | — |
Countries
United States
Contacts
Primary ContactSahar Dowlatshahi, DDS, MMSc
Backup ContactNikola Angelov
Outcome results
None listed