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

Not Applicable

Withdrawn

• Conditions: Orthodontic Malocclusion
• Interventions: Procedure: Surgically facilitated Orthodontic treatment; Procedure: Conventional orthodontic treatment

• Registration Number: NCT01866345
• Lead Sponsor: University of Minnesota

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-05-28
• Study First Posted: 2013-05-31
• Study Start: 2013-08
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgically facilitated Orthodontics	Surgically facilitated Orthodontic treatment	Surgically facilitated Orthodontic treatment in the mandibular anterior region
Conventional orthodontic treatment	Conventional orthodontic treatment	conventional orthodontic treatment in the mandibular anterior region

Primary Outcome Measures

Name	Time	Method
Rate of orthodontic tooth movement	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of mucogingival defects	6 months(plus or minus 2weeks) after initiation of treatment	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
Incidence and magnitude of apical root resorption	6(plus or minus 1) months following initiation of treatment	Incidence and magnitude of apical root resorption will be estimated from pre- and post-treatment cone-beam computed tomograms (CBCTs)