NCT06627829

Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy

Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy: a Randomized Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malocclusion, Angle Class I

Interventions

Type	Name	Description
DEVICE	Surgically 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.
DEVICE	Surgically facilitated orthodontics therapy (SFOT) using xenograft	Participants will receive SFOT using particulate xenograft and collagen membrane, prior to orthodontics treatment.
DEVICE	Usual care	Participants will have conventional orthodontics treatment with Invisalign aligners, without any surgical intervention

Timeline

• Start date: 2025-01-06
• Primary completion: 2026-01-06
• Completion: 2027-01-06
• First posted: 2024-10-04
• Last updated: 2024-10-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study