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

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.

Study Overview

• Status: Withdrawn
• Conditions: Orthodontic Malocclusion
• Intervention / Treatment: Procedure: Conventional orthodontic treatment; Procedure: Surgically facilitated Orthodontic treatment

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Conventional orthodontic treatment; conventional orthodontic treatment in the mandibular anterior region	Procedure: Conventional orthodontic treatment; Conventional orthodontic Procedure
EXPERIMENTAL: Surgically facilitated Orthodontics; Surgically facilitated Orthodontic treatment in the mandibular anterior region	Procedure: Surgically facilitated Orthodontic treatment; Surgically facilitated Orthodontic treatment in the mandibular anterior region

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Georgios A Kotsakis, DDS, Dental Fellow

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): February 1, 2014
• Study Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: May 28, 2013
• First Submitted That Met QC Criteria: May 28, 2013
• First Posted (ESTIMATE): May 31, 2013

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: orthodontics; Mandible; Osteotomy; Bone Remodeling; Tooth Movement
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: 1305M32543