Randomized, Blinded, Controlled Clinical Trial of Surgically Facilitated Orthodontic Treatment in the Mandibular Anterior Region
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Minnesota
- Primary Endpoint
- Rate of orthodontic tooth movement
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Conventional orthodontic treatment
conventional orthodontic treatment in the mandibular anterior region
Intervention: Conventional orthodontic treatment (Procedure)
Surgically facilitated Orthodontics
Surgically facilitated Orthodontic treatment in the mandibular anterior region
Intervention: Surgically facilitated Orthodontic treatment (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Incidence of mucogingival defects(6 months(plus or minus 2weeks) after initiation of treatment)
- Incidence and magnitude of apical root resorption(6(plus or minus 1) months following initiation of treatment)