Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy

The University of Texas System (UT)

Status: Not yet enrolling

Conditions: Malocclusion, Angle Class I

Treatments: Device: Usual care; Device: Surgically facilitated orthodontics therapy (SFOT) using xenograft; Device: Surgically facilitated orthodontics therapy (SFOT) using allograft

Study type: Interventional

Funder types: Other

Identifiers

NCT06627829

HSC-DB-24-0478

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Group A

Experimental group

Treatment:

Device: Surgically facilitated orthodontics therapy (SFOT) using allograft

Group B

Experimental group

Treatment:

Device: Surgically facilitated orthodontics therapy (SFOT) using xenograft

Control group

Active Comparator group

Treatment:

Device: Usual care