Malocclusion, Angle Class INCT06627829
Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy
A study testing Surgically facilitated orthodontics therapy (SFOT) using allograft and Surgically facilitated orthodontics therapy (SFOT) using xenograft in people with Malocclusion, Angle Class I, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malocclusion, Angle Class I
- What is being tested?
- Surgically facilitated orthodontics therapy (SFOT) using allograft and Surgically facilitated orthodontics therapy (SFOT) using xenograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2025to 6 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77479
Sahar Dowlatshahi, DDS, MMSc, (713) 486-4074, Sahar.Dowlatshahi@uth.tmc.edu
Nikola Angelov, (713) 486-4073, Nikola.Angelov@uth.tmc.edu
About this study
Official title: Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy: a Randomized Controlled Clinical Trial
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.
- Conditions
- Malocclusion, Angle Class I
- Being tested
- Surgically facilitated orthodontics therapy (SFOT) using allograft, Surgically facilitated orthodontics therapy (SFOT) using xenograft, Usual care
- Keywords
- orthodontic treatment
- Medical subject headings
- Malocclusion, Angle Class I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgically facilitated orthodontics therapy (SFOT) using allograftDevice
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 xenograftDevice
Participants will receive SFOT using particulate xenograft and collagen membrane, prior to orthodontics treatment.
Usual careDevice
Participants will have conventional orthodontics treatment with Invisalign aligners, without any surgical intervention
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Device: Surgically facilitated orthodontics therapy (SFOT) using allograft |
| Group B | Experimental | Not described Receives: Device: Surgically facilitated orthodontics therapy (SFOT) using xenograft |
| Control group | Active comparator | Not described Receives: Device: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in horizontal bone thickness at the 3mm point from Cementoenamel junction (CEJ) (crestal level) on the mandibular incisors
Measured: 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
Measured: 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
Measured: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
Change in volume of three dimensional bone
Measured: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
Change in volume of three dimensional soft tissue
Measured: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
Secondary outcomes (4)
Change in vertical bone level (VBL)from the CEJ
Measured: Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).
Change in probing depth (PD)
PD is the distance from CEJ to base of gingival pocket
Measured: Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).
Change in clinical attachment level (CAL)
CAL is the distance between CEJ and base of the pocket
Measured: Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).
Change in width of keratinized tissue (WKT) at alignment
Measured: Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start6 Jan 2025 (estimated)
- Primary completion6 Jan 2026 (estimated)
- Study completion6 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion, Angle Class IStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Periodontology Foundation
- Responsible party
- Principal investigator, Sahar Dowlatshahi, The University of Texas Health Science Center, Houston
- Investigators
- Sahar Dowlatshahi, DDS, MMSc, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627829
- Sponsor's protocol ID
- HSC-DB-24-0478
- Status last verified
- Sep 2024
- First submitted
- 2 Oct 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06627829
- Acronym / sponsor ID
- HSC-DB-24-0478
- Conditions
- Malocclusion, Angle Class I
- Keywords
- orthodontic treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- American Academy of Periodontology Foundation
- Study start
- 6 Jan 2025 (estimated)
- Primary completion
- 6 Jan 2026 (estimated)
- Study completion
- 6 Jan 2027 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Surgically facilitated orthodontics therapy (SFOT) using allograft |
| Group B | Experimental | Device: Surgically facilitated orthodontics therapy (SFOT) using xenograft |
| Control group | Active comparator | Device: Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- Patients who are current smokers
- Pregnancy
- Uncontrolled diabetes or other metabolic systemic conditions
- Presence of open bite or deep bite
- Spacing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgically facilitated orthodontics therapy (SFOT) using allograftParticipants will receive Surgically facilitated orthodontics therapy (SFOT) along with bone grafting using particulate allograft and collagen membrane, prior to orthodontics treatment. | Device | Group A |
| Surgically facilitated orthodontics therapy (SFOT) using xenograftParticipants will receive SFOT using particulate xenograft and collagen membrane, prior to orthodontics treatment. | Device | Group B |
| Usual careParticipants will have conventional orthodontics treatment with Invisalign aligners, without any surgical intervention | Device | Control group |
Primary outcome
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)
Change in horizontal bone thickness at the 6mm point from CEJ (middle level) on the mandibular incisors
Time frame: 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
Time frame: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
Change in volume of three dimensional bone
Time frame: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
Change in volume of three dimensional soft tissue
Time frame: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
4 secondary outcomes
Change in vertical bone level (VBL)from the CEJ
Time frame: Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).
Change in probing depth (PD)
Time frame: Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).
Change in clinical attachment level (CAL)
Time frame: Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).
Change in width of keratinized tissue (WKT) at alignment
Time frame: Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sahar Dowlatshahi, DDS, MMSc principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgically facilitated orthodontics therapy (SFOT) using allograft and Surgically facilitated orthodontics therapy (SFOT) using xenograft in people with Malocclusion, Angle Class I, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sahar Dowlatshahi, DDS, MMSc ((713) 486-4074, Sahar.Dowlatshahi@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.