Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy (NCT06627829) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy
United States24 participantsStarted 2025-01-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in horizontal bone thickness at the 3mm point from Cementoenamel junction (CEJ) (crestal level) on the mandibular incisors
Timeframe: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
2
Change in horizontal bone thickness at the 6mm point from CEJ (middle level) on the mandibular incisors
Timeframe: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
3
Change in horizontal bone thickness at the 9mm point from CEJ (apical level) on the mandibular incisors
Timeframe: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
4
Change in volume of three dimensional bone
Timeframe: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
5
Change in volume of three dimensional soft tissue
Timeframe: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
Trial details
NCT IDNCT06627829
SponsorThe University of Texas Health Science Center, Houston