Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy
NCT ID: NCT06627829
Last Updated: 2024-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
24 participants
INTERVENTIONAL
2025-01-06
2027-01-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
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.
Group B
Surgically facilitated orthodontics therapy (SFOT) using xenograft
Participants will receive SFOT using particulate xenograft and collagen membrane, prior to orthodontics treatment.
Control group
Usual care
Participants will have conventional orthodontics treatment with Invisalign aligners, without any surgical intervention
Interventions
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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.
Surgically facilitated orthodontics therapy (SFOT) using xenograft
Participants will receive SFOT using particulate xenograft and collagen membrane, prior to orthodontics treatment.
Usual care
Participants will have conventional orthodontics treatment with Invisalign aligners, without any surgical intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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American Academy of Periodontology Foundation
UNKNOWN
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Sahar Dowlatshahi
Assistant Professor
Principal Investigators
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Sahar Dowlatshahi, DDS, MMSc
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSC-DB-24-0478
Identifier Type: -
Identifier Source: org_study_id
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