Tooth CrowdingNCT01630473
Effect of Corticotomy on the Orthodontic Tooth Movement
A study testing Corticotomy and Conventional orthodontics in people with Tooth Crowding, run by Universidad de Antioquia at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Crowding
- What is being tested?
- Corticotomy and Conventional orthodontics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteColombia
- Study dates
- Aug 2011to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntary participation
- Legally adult age (>18 years old)
- Full permanent dentition (28 teeth excluding third molars)
- Severe anterior teeth crowding
- Thick periodontal biotype
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Faculty of Dentistry, Universidad de Antioquia
Medellín, Antioquia, 00000
About this study
Official title: Clinical Comparison Between the Corticotomy-assisted Orthodontics and Conventional Orthodontics
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.
Read the detailed description
The use of surgical techniques to accelerate orthodontic tooth movement has been developed. By means of surgical burs, vertical grooves in the cortical plate (corticotomy) are produced mesial and distal to the roots of teeth that are being moved 3 mm below the marginal crest and extending beyond the apex. Animal studies showed that the rapid orthodontic tooth movement was due to increased cellular activity in the surrounding periodontal tissues, a regional acceleratory phenomenon (RAP). A high osteoclastic activity is observed in the compression side although is also observed in the tension side to a less degree. Histological analysis indicates that at day 21 the remodeling tissues are replaced by a fibrous tissue and later (60 days) by bone. Furthermore, the tissues immediately adjacent to the corticotomy are characterized by an increased width of the periodontal ligament, less calcified spongiosa bone surface and higher counts of osteoclasts. But not only the catabolic activity is increased (osteoclasts) but also the anabolic activity (osteoblasts) is increased 3-fold as well. This balances the rate of bone resorption and bone apposition. An interesting finding was the reduced rate of hyalinization at the compression site, which may be due to increased width of the periodontal ligament and thus facilitating tooth movement.
As opposed to conventional osteotomy used in alveolar distraction, the preservation of the medullar vasculature during a corticotomy procedure provides and adequate blood supply and nutrition. This accelerates the rate of tissue healing and remodeling and hence orthodontic movement can start immediately after surgery. It has been calculated that the rate of tooth movement is doubled (2.5mm to 3mm at day 25) in comparison to standard orthodontics without any detrimental effects on periodontal tissues. This surgically assisted approach for improved tooth movement is beneficial for molar intrusion, space closure, de-crowding and open bite management.
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. Periodontally and systemically healthy subjects in need of orthodontic therapy for the treatment of teeth crowding in the anterior segment. The rate of tooth movement will be assessed by radiographs and cast models and periodontal clinical parameters will be recorded at each visit during the 4 month follow-up.
- Conditions
- Tooth Crowding
- Being tested
- Corticotomy, Conventional orthodontics
- Keywords
- Tooth crowding, Teeth malpositions, corticotomy, orthodontics, tooth movement, periodontal parameters
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticotomyProcedure or surgery
Also called Osteotomy
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.
Conventional orthodonticsProcedure or surgery
Also called Orthodontic treatment
Conventional orthodontic treatment
| Study group | Role | What they receive |
|---|---|---|
| Corticotomy-assisted orthodontics | Experimental | This group of patients will receive corticotomy surgical procedure at day 0. Orthodontic activation will start immediately after surgery. Receives: Procedure: Corticotomy |
| Conventional orthodontics | Active comparator | This group of patients will receive conventional orthodontics starting at day 0. Receives: Procedure: Conventional orthodontics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in tooth position
Measured: 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
Measured: 0 days, 7 days, 15 days, 1st month, 2nd month, 3rd month and 4th month after surgery and conventional orthodontic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startAug 2011
- Primary completionJan 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tooth CrowdingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Enrique Botero, Universidad de Antioquia
- Investigators
- Juan D Arango, DDS, Principal investigator, Faculty of Dentistry, Universidad de AntioquiaJavier E Botero, PhD, Study director, Faculty of Dentistry, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630473
- Sponsor's protocol ID
- CORT2011
- Status last verified
- Aug 2014
- First submitted
- 24 Jun 2012
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18533317Wilcko 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.
PubMed 11829041Ozturk 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.
PubMed 12628599Koudstaal 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.
PubMed 19278832Akay 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.
PubMed 19231781
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison Between the Corticotomy-assisted Orthodontics and Conventional Orthodontics
- ClinicalTrials.gov ID
- NCT01630473
- Acronym / sponsor ID
- CORT2011
- Conditions
- Tooth Crowding
- Keywords
- Tooth crowding, Teeth malpositions, corticotomy, orthodontics, tooth movement, periodontal parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The use of surgical techniques to accelerate orthodontic tooth movement has been developed. By means of surgical burs, vertical grooves in the cortical plate (corticotomy) are produced mesial and distal to the roots of teeth that are being moved 3 mm below the marginal crest and extending beyond the apex. Animal studies showed that the rapid orthodontic tooth movement was due to increased cellular activity in the surrounding periodontal tissues, a regional acceleratory phenomenon (RAP). A high osteoclastic activity is observed in the compression side although is also observed in the tension side to a less degree. Histological analysis indicates that at day 21 the remodeling tissues are replaced by a fibrous tissue and later (60 days) by bone. Furthermore, the tissues immediately adjacent to the corticotomy are characterized by an increased width of the periodontal ligament, less calcified spongiosa bone surface and higher counts of osteoclasts. But not only the catabolic activity is increased (osteoclasts) but also the anabolic activity (osteoblasts) is increased 3-fold as well. This balances the rate of bone resorption and bone apposition. An interesting finding was the reduced rate of hyalinization at the compression site, which may be due to increased width of the periodontal ligament and thus facilitating tooth movement.
As opposed to conventional osteotomy used in alveolar distraction, the preservation of the medullar vasculature during a corticotomy procedure provides and adequate blood supply and nutrition. This accelerates the rate of tissue healing and remodeling and hence orthodontic movement can start immediately after surgery. It has been calculated that the rate of tooth movement is doubled (2.5mm to 3mm at day 25) in comparison to standard orthodontics without any detrimental effects on periodontal tissues. This surgically assisted approach for improved tooth movement is beneficial for molar intrusion, space closure, de-crowding and open bite management.
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. Periodontally and systemically healthy subjects in need of orthodontic therapy for the treatment of teeth crowding in the anterior segment. The rate of tooth movement will be assessed by radiographs and cast models and periodontal clinical parameters will be recorded at each visit during the 4 month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticotomy-assisted orthodontics | Experimental | Procedure: CorticotomyThis group of patients will receive corticotomy surgical procedure at day 0. Orthodontic activation will start immediately after surgery. |
| Conventional orthodontics | Active comparator | Procedure: Conventional orthodonticsThis group of patients will receive conventional orthodontics starting at day 0. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Voluntary participation
- Legally adult age (>18 years old)
- Full permanent dentition (28 teeth excluding third molars)
- Severe anterior teeth crowding
- Thick periodontal biotype
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorticotomyAlso: OsteotomyAfter 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. | Procedure or surgery | Corticotomy-assisted orthodontics |
| Conventional orthodonticsAlso: Orthodontic treatmentConventional orthodontic treatment | Procedure or surgery | Conventional orthodontics |
Primary outcome
Changes in tooth position
Time frame: 0 days, 7 days, 15 days, 1st month, 2nd month, 3rd month and 4th month after surgery and conventional orthodontic
1 secondary outcome
Periodontal Clinical Parameters
Time frame: 0 days, 7 days, 15 days, 1st month, 2nd month, 3rd month and 4th month after surgery and conventional orthodontic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- Background: PubMed 18533317Nowzari 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.
- Background: PubMed 11829041Wilcko 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.
- Background: PubMed 12628599Ozturk 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.
- Background: PubMed 19278832Koudstaal 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.
- Background: PubMed 19231781Akay 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan D Arango, DDS principal investigator
Faculty of Dentistry, Universidad de Antioquia
Javier E Botero, PhD study director
Faculty of Dentistry, Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corticotomy and Conventional orthodontics in people with Tooth Crowding, run by Universidad de Antioquia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in tooth position (time frame: 0 days, 7 days, 15 days, 1st month, 2nd month, 3rd month and 4th month after surgery and conventional orthodontic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01630473, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2014.