Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06627829
Status
Not Yet Recruiting

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Conditions

  • Malocclusion, Angle Class I

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Surgically facilitated orthodontics therapy (SFOT) using allograft — DEVICE
    Participants will receive Surgically facilitated orthodontics therapy (SFOT) along with bone grafting using particulate allograft and collagen membrane, prior to orthodontics treatment.
  • Surgically facilitated orthodontics therapy (SFOT) using xenograft — DEVICE
    Participants will receive SFOT using particulate xenograft and collagen membrane, prior to orthodontics treatment.
  • Usual care — DEVICE
    Participants will have conventional orthodontics treatment with Invisalign aligners, without any surgical intervention

Study Details

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.

Key Dates

Start date
Jan 6, 2025
Status verified
Sep 2024
Primary completion
Jan 6, 2026
Completion
Jan 6, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
  • Experimental: Group B
  • Active Comparator: Control group

Primary Outcome Measure

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77479
Sahar Dowlatshahi, DDS, MMSc
[email protected]
(713) 486-4074
Nikola Angelov
[email protected]
(713) 486-4073

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The University of Texas Health Science Center at Houston· Houston, TX