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Study on Grafting Materials for Orthodontics Therapy

This study is looking at different ways to improve orthodontic treatment for people with mild teeth crowding (malocclusion, Angle Class I). Researchers want to see how two types of bone grafting materials, allograft and xenograft, affect the bone and gum tissue around your lower front teeth when used with Surgically Facilitated Orthodontics Therapy (SFOT). SFOT involves a minor surgical procedure to help teeth move faster. The study will compare these two methods to traditional orthodontics using Invisalign aligners without surgery. You might be able to join if you are 18 or older, have good gum health, and have specific measurements for your teeth and jaw. The main goal is to measure changes in the thickness of your jawbone around your lower front teeth about 4 months after orthodontics treatment starts.

Study design
This interventional study plans to enroll 24 participants. It compares two surgical approaches with bone grafting (allograft or xenograft) to conventional orthodontics.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements are taken at baseline and approximately 4 months after the start of orthodontics treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06627829

Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy

Not Yet Recruiting
NAAges 18+InterventionalTreatment
The University of Texas Health Science Center, Houston
~24 participants
Updated 2024-10-04 on ClinicalTrials.gov
What's tested:Surgically facilitated orthodontics therapy (SFOT) using allograftSurgically facilitated orthodontics therapy (SFOT) using xenograftUsual care

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in horizontal bone thickness at the 3mm point from Cementoenamel junction (CEJ) (crestal level) on the mandibular incisors
Measured over from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
+4 more outcomes measured

Conditions

Malocclusion, Angle Class I

Explore related trials

Malocclusion

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Sahar Dowlatshahi, DDS, MMSc · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Sahar Dowlatshahi, DDS, MMSc
[email protected]
(713) 486-4074
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in horizontal bone thickness at the 3mm point from Cementoenamel junction (CEJ) (crestal level) on the mandibular incisorsfrom 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 incisorsfrom 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 incisorsfrom baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
  • Change in volume of three dimensional bonefrom baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
  • Change in volume of three dimensional soft tissuefrom baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)