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

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Withdrawn

Conditions

Orthodontic Malocclusion

Treatments

Procedure: Surgically facilitated Orthodontic treatment
Procedure: Conventional orthodontic treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01866345
1305M32543

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

Conventional orthodontic treatment
Active Comparator group
Description:
conventional orthodontic treatment in the mandibular anterior region
Treatment:
Procedure: Conventional orthodontic treatment
Surgically facilitated Orthodontics
Experimental group
Description:
Surgically facilitated Orthodontic treatment in the mandibular anterior region
Treatment:
Procedure: Surgically facilitated Orthodontic treatment

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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