Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy

Not Applicable

Not yet recruiting

• Conditions: Malocclusion, Angle Class I
• Interventions: Device: Surgically facilitated orthodontics therapy (SFOT) using allograft; Device: Surgically facilitated orthodontics therapy (SFOT) using xenograft; Device: Usual care

• Registration Number: NCT06627829
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-02
• Last Update Submitted: 2024-10-02
• Study First Posted: 2024-10-04
• Last Update Posted: 2024-10-04
• Study Start: 2025-01-06
• Primary Completion: 2026-01-06
• Study Completion: 2027-01-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Surgically facilitated orthodontics therapy (SFOT) using allograft	-
Group B	Surgically facilitated orthodontics therapy (SFOT) using xenograft	-
Control group	Usual care	-

Primary Outcome Measures

Name	Time	Method
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 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)
Change in volume of three dimensional bone	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)

Secondary Outcome Measures

Name	Time	Method
Change in vertical bone level (VBL)from the CEJ	Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).
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).

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States