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

NCT01866345 | Withdrawn

• 1 other identifier: 1305M32543
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Orthodontic Malocclusion

Keywords

orthodontics; Tooth Movement; Bone Remodeling; Mandible; Osteotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Other Outcomes (1)

• Thickness and height of the buccal and lingual bony plates

  6(plus or minus 1) months following initiation of treatment

Study Arms (2)

Conventional orthodontic treatment

ACTIVE COMPARATOR

conventional orthodontic treatment in the mandibular anterior region

Procedure: Conventional orthodontic treatment

Surgically facilitated Orthodontics

EXPERIMENTAL

Surgically facilitated Orthodontic treatment in the mandibular anterior region

Procedure: Surgically facilitated Orthodontic treatment

Interventions

Surgically facilitated Orthodontic treatment PROCEDURE

Surgically facilitated Orthodontic treatment in the mandibular anterior region

Surgically facilitated Orthodontics

Conventional orthodontic treatment PROCEDURE

Conventional orthodontic Procedure

Conventional orthodontic treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Related 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. No abstract available.

  PMID: 19761909 BACKGROUND

• 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.

  PMID: 18771369 BACKGROUND

Study Officials

• Georgios A Kotsakis, DDS

  Dental Fellow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: May 31, 2013
• Study Start: August 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: November 1, 2019

Record last verified: 2019-10