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

Orthodontic Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01866345
• Other study ID #: 1305M32543
• Status: Withdrawn
• Phase: N/A
• Start date: August 2013
• Est. completion date: February 2014

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 correct crowding and/or retroclination of their mandibular anterior dentition.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion
• Orthodontic Malocclusion

Intervention

Procedure:
• Surgically facilitated Orthodontic treatment
Surgically facilitated Orthodontic treatment in the mandibular anterior region
• Conventional orthodontic treatment
Conventional orthodontic Procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

References & Publications (2)

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. — View 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 . — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Thickness and height of the buccal and lingual bony plates	Thickness and height of the buccal and lingual bony plates will be measured from pre- and post-treatment Cone beam volumetric tomograms	6(plus or minus 1) months following initiation of treatment
Primary	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.	6 months(plus or minus 1 week)
Secondary	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	6 months(plus or minus 2weeks) after initiation of treatment
Secondary	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)	6(plus or minus 1) months following initiation of treatment