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

NCT ID: NCT01866345

Last Updated: 2019-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-02-28

Brief Summary

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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

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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.

Conditions

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Orthodontic Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional orthodontic treatment

conventional orthodontic treatment in the mandibular anterior region

Group Type ACTIVE_COMPARATOR

Conventional orthodontic treatment

Intervention Type PROCEDURE

Conventional orthodontic Procedure

Surgically facilitated Orthodontics

Surgically facilitated Orthodontic treatment in the mandibular anterior region

Group Type EXPERIMENTAL

Surgically facilitated Orthodontic treatment

Intervention Type PROCEDURE

Surgically facilitated Orthodontic treatment in the mandibular anterior region

Interventions

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Surgically facilitated Orthodontic treatment

Surgically facilitated Orthodontic treatment in the mandibular anterior region

Intervention Type PROCEDURE

Conventional orthodontic treatment

Conventional orthodontic Procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Georgios A Kotsakis, DDS

Role: PRINCIPAL_INVESTIGATOR

Dental Fellow

References

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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.

Reference Type BACKGROUND
PMID: 19761909 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18771369 (View on PubMed)

Other Identifiers

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1305M32543

Identifier Type: -

Identifier Source: org_study_id

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