An interventional study of Surgically facilitated orthodontics therapy (SFOT) using allograft and Surgically facilitated orthodontics therapy (SFOT) using xenograft in Malocclusion, Angle Class I, sponsored by The University of Texas Health Science Center, Houston. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-04.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
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.
35 studies on the registry are indexed under Malocclusion, Angle Class I; 10 are open to participants now.
This study's planned enrollment of 24 is below the median of 32 across 31 interventional studies indexed under Malocclusion, Angle Class I.
Browse Malocclusion, Angle Class I studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Surgically facilitated orthodontics therapy (SFOT) using allograft
Device: Surgically facilitated orthodontics therapy (SFOT) using xenograft
Device: Usual care
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
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
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).
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2025; primary completion for Jan 2026, 12 months later.
Of 23 interventional studies with no phase under Malocclusion, Angle Class I, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 24. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston →