NCT01630473

Brief Summary

Orthodontic therapy allows for the treatment of dental malpositions in order to produce an adequate relationship between teeth during occlusion. Conventional orthodontic therapy applies slight forces and moves teeth slowly. It is generally performed during a 2 year minimum of time. Recent studies seem to suggest that orthodontic therapy time can be shortened by surgical assistance (corticotomy). This investigation is aimed to determine the velocity of tooth movement and changes in periodontal clinical parameters between corticotomy-assisted orthodontic therapy and conventional orthodontic therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 15, 2014

Status Verified

August 1, 2014

Enrollment Period

1.4 years

First QC Date

June 24, 2012

Last Update Submit

August 13, 2014

Conditions

Keywords

Tooth crowdingTeeth malpositionscorticotomyorthodonticstooth movementperiodontal parameters

Outcome Measures

Primary Outcomes (1)

  • Changes in tooth position

    0 days, 7 days, 15 days, 1st month, 2nd month, 3rd month and 4th month after surgery and conventional orthodontic

Secondary Outcomes (1)

  • Periodontal Clinical Parameters

    0 days, 7 days, 15 days, 1st month, 2nd month, 3rd month and 4th month after surgery and conventional orthodontic

Study Arms (2)

Corticotomy-assisted orthodontics

EXPERIMENTAL

This group of patients will receive corticotomy surgical procedure at day 0. Orthodontic activation will start immediately after surgery.

Procedure: Corticotomy

Conventional orthodontics

ACTIVE COMPARATOR

This group of patients will receive conventional orthodontics starting at day 0.

Procedure: Conventional orthodontics

Interventions

CorticotomyPROCEDURE

After a periodontal full flap is dissected, by using small round burs, vertical lines (2 mm depth corticotomy) parallel to each root of the teeth in the anterior segment (canines and incisors) are created 5 mm beyond the apex in the maxillary bones and interconnecting the lines at the apex by horizontal corticotomies. Marginal bone crest is not touched by the surgical procedure.

Also known as: Osteotomy
Corticotomy-assisted orthodontics

Conventional orthodontic treatment

Also known as: Orthodontic treatment
Conventional orthodontics

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Voluntary participation
  • Legally adult age (\>18 years old)
  • Full permanent dentition (28 teeth excluding third molars)
  • Severe anterior teeth crowding
  • Thick periodontal biotype

You may not qualify if:

  • Systemic diseases (i.e. diabetes, HIV)
  • cigarette smoking
  • Under medications: bisphosphonates, anti-epileptic drugs, contraceptives, corticosteroids, estrogen, antihistamine drugs, calcitonin, vitamin D
  • Previous orthodontic treatment
  • Periodontal disease
  • Severe gingival recessions
  • Pregnancy
  • Previous root resorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Universidad de Antioquia

MedellĂ­n, Antioquia, 00000, Colombia

Location

Related Publications (5)

  • Nowzari H, Yorita FK, Chang HC. Periodontally accelerated osteogenic orthodontics combined with autogenous bone grafting. Compend Contin Educ Dent. 2008 May;29(4):200-6; quiz 207, 218.

    PMID: 18533317BACKGROUND
  • Wilcko WM, Wilcko T, Bouquot JE, Ferguson DJ. Rapid orthodontics with alveolar reshaping: two case reports of decrowding. Int J Periodontics Restorative Dent. 2001 Feb;21(1):9-19.

    PMID: 11829041BACKGROUND
  • Ozturk M, Doruk C, Ozec I, Polat S, Babacan H, Bicakci AA. Pulpal blood flow: effects of corticotomy and midline osteotomy in surgically assisted rapid palatal expansion. J Craniomaxillofac Surg. 2003 Apr;31(2):97-100. doi: 10.1016/s1010-5182(02)00188-9.

    PMID: 12628599BACKGROUND
  • Koudstaal MJ, Wolvius EB, Schulten AJ, Hop WC, van der Wal KG. Stability, tipping and relapse of bone-borne versus tooth-borne surgically assisted rapid maxillary expansion; a prospective randomized patient trial. Int J Oral Maxillofac Surg. 2009 Apr;38(4):308-15. doi: 10.1016/j.ijom.2009.02.012. Epub 2009 Mar 10.

    PMID: 19278832BACKGROUND
  • Akay MC, Aras A, Gunbay T, Akyalcin S, Koyuncue BO. Enhanced effect of combined treatment with corticotomy and skeletal anchorage in open bite correction. J Oral Maxillofac Surg. 2009 Mar;67(3):563-9. doi: 10.1016/j.joms.2008.06.091.

    PMID: 19231781BACKGROUND

MeSH Terms

Conditions

Malocclusion

Interventions

OsteotomyOrthodontics

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, OperativeDentistry

Study Officials

  • Juan D Arango, DDS

    Faculty of Dentistry, Universidad de Antioquia

    PRINCIPAL INVESTIGATOR
  • Javier E Botero, PhD

    Faculty of Dentistry, Universidad de Antioquia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Time Professor of Periodontics

Study Record Dates

First Submitted

June 24, 2012

First Posted

June 28, 2012

Study Start

August 1, 2011

Primary Completion

January 1, 2013

Study Completion

August 1, 2013

Last Updated

August 15, 2014

Record last verified: 2014-08

Locations