Orthodontic MalocclusionNCT01866345
Randomized, Blinded, Controlled Clinical Trial of Surgically Facilitated Orthodontic Treatment
A study testing Surgically facilitated Orthodontic treatment and Conventional orthodontic treatment in people with Orthodontic Malocclusion, run by University of Minnesota.
Trial summary
The purpose of this investigation is intended to evaluate the efficacy of surgically facilitated orthodontic treatment (SFO) in terms of treatment time, incidence of root shortening, and occurrence of mucogingival side effects compared to conventional orthodontic therapy in patients undergoing orthodontic treatment to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Orthodontic Malocclusion
- What is being tested?
- Surgically facilitated Orthodontic treatment and Conventional orthodontic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Adults (18-65 y.o.) who seek orthodontic treatment for proclination and/or de-crowding of mandibular anterior teeth.
Who cannot join
- Bone-related diseases
- Previous or current use of biphosphate therapy
- Previous mucogingival surgery in the area
- Genetic syndromes, craniofacial anomalies, or cleft lip and/or palate
- History of previous orthodontic treatment less than 4 years ago
- Smoking >10 cigarettes/day )
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- Medical history that contraindicates surgical treatment,
- People who are not cognitively able to give consent,
- Pregnancy
About this study
Official title: Randomized, Blinded, Controlled Clinical Trial of Surgically Facilitated Orthodontic Treatment in the Mandibular Anterior Region
The purpose of this investigation is intended to evaluate the efficacy of surgically facilitated orthodontic treatment (SFO) in terms of treatment time, incidence of root shortening, and occurrence of mucogingival side effects compared to conventional orthodontic therapy in patients undergoing orthodontic treatment to correct crowding and/or retroclination of their mandibular anterior dentition.
Read the detailed description
The null-hypothesis for this research project is that there will be no difference in the rate of orthodontic movement among patients requiring proclination or alignment of their mandibular anterior teeth with SFO (TEST group) as compared to conventional orthodontic treatment (CONTROL group). A null-hypothesis is that there will be no difference between both treatment groups in the occurrence of dental (root shortening) or periodontal (mucogingival defects, alveolar bone resorption) complications associated with orthodontic treatment.
- Conditions
- Orthodontic Malocclusion
- Being tested
- Surgically facilitated Orthodontic treatment, Conventional orthodontic treatment
- Keywords
- orthodontics, Tooth Movement, Bone Remodeling, Mandible, Osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgically facilitated Orthodontic treatmentProcedure or surgery
Surgically facilitated Orthodontic treatment in the mandibular anterior region
Conventional orthodontic treatmentProcedure or surgery
Conventional orthodontic Procedure
| Study group | Role | What they receive |
|---|---|---|
| Conventional orthodontic treatment | Active comparator | conventional orthodontic treatment in the mandibular anterior region Receives: Procedure: Conventional orthodontic treatment |
| Surgically facilitated Orthodontics | Experimental | Surgically facilitated Orthodontic treatment in the mandibular anterior region Receives: Procedure: Surgically facilitated Orthodontic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of orthodontic tooth movement
Difference between the rate of orthodontic tooth movement between the two groups as measured by linear measurements on digitized study casts obtained at 4-week intervals.
Measured: 6 months(plus or minus 1 week)
Secondary outcomes (2)
Incidence of mucogingival defects
Incidence of mucogingival defects as clinically measured by gingival recession (GR), clinical attachment level (CAL), probing depth (PD), width of keratinized tissue (WKT) and biotype), by a calibrated examiner
Measured: 6 months(plus or minus 2weeks) after initiation of treatment
Incidence and magnitude of apical root resorption
Incidence and magnitude of apical root resorption will be estimated from pre- and post-treatment cone-beam computed tomograms (CBCTs)
Measured: 6(plus or minus 1) months following initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Cannot find subjects to particpate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Orthodontic MalocclusionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georgios A Kotsakis, DDS, Principal investigator, Dental Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866345
- Sponsor's protocol ID
- 1305M32543
- Status last verified
- Oct 2019
- First submitted
- 28 May 2013
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Murphy KG, Wilcko MT, Wilcko WM, Ferguson DJ. Periodontal accelerated osteogenic orthodontics: a description of the surgical technique. J Oral Maxillofac Surg. 2009 Oct;67(10):2160-6. doi: 10.1016/j.joms.2009.04.124. No abstract available.
PubMed 19761909Sebaoun JD, Kantarci A, Turner JW, Carvalho RS, Van Dyke TE, Ferguson DJ. Modeling of trabecular bone and lamina dura following selective alveolar decortication in rats. J Periodontol. 2008 Sep;79(9):1679-88. doi: 10.1902/jop.2008.080024.
PubMed 18771369
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Blinded, Controlled Clinical Trial of Surgically Facilitated Orthodontic Treatment in the Mandibular Anterior Region
- ClinicalTrials.gov ID
- NCT01866345
- Acronym / sponsor ID
- 1305M32543
- Conditions
- Orthodontic Malocclusion
- Keywords
- orthodontics, Tooth Movement, Bone Remodeling, Mandible, Osteotomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Cannot find subjects to particpate
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 31 May 2013 (estimated)
- 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 investigation is intended to evaluate the efficacy of surgically facilitated orthodontic treatment (SFO) in terms of treatment time, incidence of root shortening, and occurrence of mucogingival side effects compared to conventional orthodontic therapy in patients undergoing orthodontic treatment to correct crowding and/or retroclination of their mandibular anterior dentition.
Detailed description
The null-hypothesis for this research project is that there will be no difference in the rate of orthodontic movement among patients requiring proclination or alignment of their mandibular anterior teeth with SFO (TEST group) as compared to conventional orthodontic treatment (CONTROL group). A null-hypothesis is that there will be no difference between both treatment groups in the occurrence of dental (root shortening) or periodontal (mucogingival defects, alveolar bone resorption) complications associated with orthodontic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional orthodontic treatment | Active comparator | Procedure: Conventional orthodontic treatmentconventional orthodontic treatment in the mandibular anterior region |
| Surgically facilitated Orthodontics | Experimental | Procedure: Surgically facilitated Orthodontic treatmentSurgically facilitated Orthodontic treatment in the mandibular anterior region |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Adults (18-65 y.o.) who seek orthodontic treatment for proclination and/or de-crowding of mandibular anterior teeth.
Key exclusion criteria (9 listed)
- Bone-related diseases
- Previous or current use of biphosphate therapy
- Previous mucogingival surgery in the area
- Genetic syndromes, craniofacial anomalies, or cleft lip and/or palate
- Smoking >10 cigarettes/day )
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 Orthodontic treatmentSurgically facilitated Orthodontic treatment in the mandibular anterior region | Procedure or surgery | Surgically facilitated Orthodontics |
| Conventional orthodontic treatmentConventional orthodontic Procedure | Procedure or surgery | Conventional orthodontic treatment |
Primary outcome
Rate of orthodontic tooth movement
Time frame: 6 months(plus or minus 1 week)
Difference between the rate of orthodontic tooth movement between the two groups as measured by linear measurements on digitized study casts obtained at 4-week intervals.
2 secondary outcomes
Incidence of mucogingival defects
Time frame: 6 months(plus or minus 2weeks) after initiation of treatment
Incidence and magnitude of apical root resorption
Time frame: 6(plus or minus 1) months following initiation of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Background: PubMed 19761909Murphy KG, Wilcko MT, Wilcko WM, Ferguson DJ. Periodontal accelerated osteogenic orthodontics: a description of the surgical technique. J Oral Maxillofac Surg. 2009 Oct;67(10):2160-6. doi: 10.1016/j.joms.2009.04.124. No abstract available.
- Background: PubMed 18771369Sebaoun JD, Kantarci A, Turner JW, Carvalho RS, Van Dyke TE, Ferguson DJ. Modeling of trabecular bone and lamina dura following selective alveolar decortication in rats. J Periodontol. 2008 Sep;79(9):1679-88. doi: 10.1902/jop.2008.080024.
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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. This study is not recruiting at the moment.
Georgios A Kotsakis, DDS principal investigator
Dental Fellow
Questions about this trial
What is this clinical trial studying?
A study testing Surgically facilitated Orthodontic treatment and Conventional orthodontic treatment in people with Orthodontic Malocclusion, run by University of Minnesota.
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 1 inclusion and 9 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: withdrawn, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of orthodontic tooth movement (time frame: 6 months(plus or minus 1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01866345, which also lists 2 linked publications.
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 1 Nov 2019.