Clinical trial NCT01866345: Randomized, Blinded, Controlled Clinical Trial of Surgically Facilitated Orthodontic Treatment
Official title: Randomized, Blinded, Controlled Clinical Trial of Surgically Facilitated Orthodontic Treatment in the Mandibular Anterior Region
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Orthodontic Malocclusion
Keywords: orthodontics
Tooth Movement
Bone Remodeling
Mandible
Osteotomy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of orthodontic tooth movement
timeFrame: 6 months(plus or minus 1 week)
Secondary outcomes:
measure: Incidence of mucogingival defects
timeFrame: 6 months(plus or minus 2weeks) after initiation of treatment
measure: Incidence and magnitude of apical root resorption
timeFrame: 6(plus or minus 1) months following initiation of treatment
Other outcomes:
measure: Thickness and height of the buccal and lingual bony plates
timeFrame: 6(plus or minus 1) months following initiation of treatment
Locations:
Study officials:
affiliation: Dental Fellow
name: Georgios A Kotsakis, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sebaoun 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.