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Randomized, Blinded, Controlled Clinical Trial of Surgically Facilitated Orthodontic Treatment

Randomized, Blinded, Controlled Clinical Trial of Surgically Facilitated Orthodontic Treatment in the Mandibular Anterior Region

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01866345
Enrollment
0
Registered
2013-05-31
Start date
2013-08-31
Completion date
2014-02-28
Last updated
2019-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontic Malocclusion

Keywords

orthodontics, Tooth Movement, Bone Remodeling, Mandible, Osteotomy

Brief 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 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.

Interventions

PROCEDURESurgically facilitated Orthodontic treatment

Surgically facilitated Orthodontic treatment in the mandibular anterior region

Conventional orthodontic Procedure

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

-Adults (18-65 y.o.) who seek orthodontic treatment for proclination and/or de-crowding of mandibular anterior teeth.

Exclusion criteria

* 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 ) * Medical history that contraindicates surgical treatment, * People who are not cognitively able to give consent, * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Rate of orthodontic tooth movement6 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.

Secondary

MeasureTime frameDescription
Incidence of mucogingival defects6 months(plus or minus 2weeks) after initiation of treatmentIncidence 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
Incidence and magnitude of apical root resorption6(plus or minus 1) months following initiation of treatmentIncidence and magnitude of apical root resorption will be estimated from pre- and post-treatment cone-beam computed tomograms (CBCTs)

Other

MeasureTime frameDescription
Thickness and height of the buccal and lingual bony plates6(plus or minus 1) months following initiation of treatmentThickness and height of the buccal and lingual bony plates will be measured from pre- and post-treatment Cone beam volumetric tomograms

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026