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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Participants will receive Surgically facilitated orthodontics therapy (SFOT) along with bone grafting using particulate allograft and collagen membrane, prior to orthodontics treatment.
Participants will receive SFOT using particulate xenograft and collagen membrane, prior to orthodontics treatment.
Participants will have conventional orthodontics treatment with Invisalign aligners, without any surgical intervention
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Change in horizontal bone thickness at the 3mm point from Cementoenamel junction (CEJ) (crestal level) on the mandibular incisors
Time frame: 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
Time frame: 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
Time frame: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
Change in volume of three dimensional bone
Time frame: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
Change in volume of three dimensional soft tissue
Time frame: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
Change in vertical bone level (VBL)from the CEJ
Time frame: 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
Time frame: 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
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Time frame: Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).
Change in width of keratinized tissue (WKT) at alignment
Time frame: Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).