Malocclusion, Class I/IINCT04999150
Comparison of Corticotomy and Micro-Osteoperforation During Canine Retraction
A study testing Micro-Osteoperforations and Corticotomy in people with Malocclusion, Class I/II, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial summary
Corticotomy and micro-osteoperforation (MOP) have been proven to accelerate tooth movement and shorten orthodontic treatment time, compared to conventional treatment. MOP is less invasive; however, it is unclear whether it is as effective as a corticotomy. Read more about this study
- Who is it for?
- Ages 12 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Class I/II
- What is being tested?
- Micro-Osteoperforations and Corticotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 2 Oct 2018to 26 Sep 2020
- 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 12 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy permanent dentition requiring the extraction of maxillary first premolars with less than 8mm of maxillary anterior crowding
Who cannot join
- Previous orthodontic or endodontic treatment of the canines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Split-Mouth Randomized Clinical Trial for the Comparison of Corticotomy and Micro-Osteoperforations During Canine Retraction: A Pilot Study
Corticotomy and micro-osteoperforation (MOP) have been proven to accelerate tooth movement and shorten orthodontic treatment time, compared to conventional treatment. MOP is less invasive; however, it is unclear whether it is as effective as a corticotomy. The purpose of this study was to compare the maxillary canine retraction achieved by these techniques.
Read the detailed description
Thirteen patients (5 females, 8 males; mean age, 18.07±6.74 years) with healthy permanent dentition requiring the extraction of maxillary first premolars were included in a split-mouth randomized clinical trial. Subjects with previous orthodontic or endodontic treatment of canines were excluded. At least 3 months post-extraction, MOPs, and corticotomies were performed distal to the canines. Mini-screws with closed-coil springs (150g) were used for canine retraction. Dental casts were attained at baseline (T0) and 3 months post-intervention (T1). Calibrated examiners measured the distances from the canine to the second premolar on both sides. A Signed-rank sum test was used to compare canine retraction achieved in 3 months (T0-T1) in two sides
- Conditions
- Malocclusion, Class I/II
- Being tested
- Micro-Osteoperforations, Corticotomy
- Keywords
- Corticotomy; MOP; Tooth movement
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-OsteoperforationsProcedure or surgery
Also called MOP
MOPs were performed with a stainless-steel manual drill tip that had 1.6mm diameter with an adjustable depth set to 5mm (Excellerator® RT; Propel Orthodontics, Milpitas, CA).
Six perforations were made along 2 parallel vertical lines (each line with 3 holes spaced ~2mm apart) distal to the canine and perpendicular to the buccal cortical bone.
The mini-screws were placed. A NiTi closed-coil spring was placed and secured with a 0.014"SS ligature wire at the canine and mini-screw. A Dontrix gauge was used to measure the force (150g)
CorticotomyProcedure or surgery
A full-thickness labial mucoperiosteal flap was reflected. Two vertical corticotomies (1 mesial and 1 distal to the canine) were performed. The cortical bone was cut 2 to 3 mm below the alveolar crest towards the apex, until bone marrow was exposed.
Cortical-cancellous bone grafts (0.5cc; PuraGraft, Kingwood, TX) were placed at the corticotomy sites.
The mini-screws were placed. A nickel-titanium (NiTi) closed-coil spring was placed and secured with a 0.014"SS ligature wire at the canine and mini-screw. A Dontrix gauge (Orthopli Corp., Philadelphia, PA) was used to measure the force (150g)
| Study group | Role | What they receive |
|---|---|---|
| Corticotomy | Active comparator | 1. A full-thickness labial mucoperiosteal flap was reflected.
2. Two vertical corticotomies (1 mesial and 1 distal to the canine) were performed . The cortical bone was cut 2 to 3 mm below the alveolar crest towards the apex until bone marrow was exposed.
3. Cortical-cancellous bone grafts (0.5cc; PuraGraft, Kingwood, TX) were placed at the corticotomy sites.
4. The mini-screws were placed.
5. A nickel-titanium (NiTi) closed-coil spring was placed and secured with a 0.014"SS ligature wire at the canine and mini-screw. A Dontrix gauge (Orthopli Corp., Philadelphia, PA) was used to measure the force (150g). Receives: Procedure: Corticotomy |
| Micro-Osteoperforation | Experimental | 1. MOPs were performed with a stainless-steel manual drill tip that had 1.6mm diameter with an adjustable depth set to 5mm (Excellerator® RT; Propel Orthodontics, Milpitas, CA).
2. Six perforations were made along 2 parallel vertical lines (each line with 3 holes spaced ~2mm apart) distal to the canine and perpendicular to the buccal cortical bone.
3. The mini-screws were placed.
4. A NiTi closed-coil spring was placed and secured with a 0.014"SS ligature wire at the canine and mini-screw. A Dontrix gauge was used to measure the force (150g). Receives: Procedure: Micro-Osteoperforations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canine retraction
Amount of tooth movement (in mm) attained by the maxillary canines after retracting them
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start2 Oct 2018
- Primary completion11 Jul 2019
- Study completion26 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Malocclusion, Class I/IIStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- a split-mouth randomized clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zagreb
- Responsible party
- Sponsor
- Investigators
- Augusto R Elias, DMD,MSD, Study director, Assitant Dean of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999150
- Sponsor's protocol ID
- UPR MSC IRB B0710118
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Y, Jacox LA, Little SH, Ko CC. Orthodontic tooth movement: The biology and clinical implications. Kaohsiung J Med Sci. 2018 Apr;34(4):207-214. doi: 10.1016/j.kjms.2018.01.007. Epub 2018 Feb 3.
PubMed 29655409Aboul-Ela SM, El-Beialy AR, El-Sayed KM, Selim EM, El-Mangoury NH, Mostafa YA. Miniscrew implant-supported maxillary canine retraction with and without corticotomy-facilitated orthodontics. Am J Orthod Dentofacial Orthop. 2011 Feb;139(2):252-9. doi: 10.1016/j.ajodo.2009.04.028.
PubMed 21300255Frost HM. The regional acceleratory phenomenon: a review. Henry Ford Hosp Med J. 1983;31(1):3-9. No abstract available.
PubMed 6345475Verna C. Regional Acceleratory Phenomenon. Front Oral Biol. 2016;18:28-35. doi: 10.1159/000351897. Epub 2015 Nov 24.
PubMed 26599115Aboalnaga AA, Salah Fayed MM, El-Ashmawi NA, Soliman SA. Effect of micro-osteoperforation on the rate of canine retraction: a split-mouth randomized controlled trial. Prog Orthod. 2019 Jun 3;20(1):21. doi: 10.1186/s40510-019-0274-0.
PubMed 31155698Cheung T, Park J, Lee D, Kim C, Olson J, Javadi S, Lawson G, McCabe J, Moon W, Ting K, Hong C. Ability of mini-implant-facilitated micro-osteoperforations to accelerate tooth movement in rats. Am J Orthod Dentofacial Orthop. 2016 Dec;150(6):958-967. doi: 10.1016/j.ajodo.2016.04.030.
PubMed 27894545Fischer TJ. Orthodontic treatment acceleration with corticotomy-assisted exposure of palatally impacted canines. Angle Orthod. 2007 May;77(3):417-20. doi: 10.2319/0003-3219(2007)077[0417:OTAWCE]2.0.CO;2.
PubMed 17465647Leethanakul C, Kanokkulchai S, Pongpanich S, Leepong N, Charoemratrote C. Interseptal bone reduction on the rate of maxillary canine retraction. Angle Orthod. 2014 Sep;84(5):839-45. doi: 10.2319/100613-737.1. Epub 2014 Mar 4.
PubMed 24592904Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.
PubMed 24182579AMLER MH, JOHNSON PL, SALMAN I. Histological and histochemical investigation of human alveolar socket healing in undisturbed extraction wounds. J Am Dent Assoc. 1960 Jul;61:32-44. doi: 10.14219/jada.archive.1960.0152. No abstract available.
PubMed 13793201Arreghini A, Lombardo L, Mollica F, Siciliani G. Torque expression capacity of 0.018 and 0.022 bracket slots by changing archwire material and cross section. Prog Orthod. 2014 Sep 25;15(1):53. doi: 10.1186/s40510-014-0053-x.
PubMed 25329505Pandis N, Walsh T, Polychronopoulou A, Katsaros C, Eliades T. Split-mouth designs in orthodontics: an overview with applications to orthodontic clinical trials. Eur J Orthod. 2013 Dec;35(6):783-9. doi: 10.1093/ejo/cjs108. Epub 2013 Feb 1.
PubMed 23376899Alikhani M, Alansari S, Sangsuwon C, et al. Micro-osteoperforations: Minimally invasive accelerated tooth movement. Semin Orthod. 2015; 21(3): 162-169.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Split-Mouth Randomized Clinical Trial for the Comparison of Corticotomy and Micro-Osteoperforations During Canine Retraction: A Pilot Study
- ClinicalTrials.gov ID
- NCT04999150
- Acronym / sponsor ID
- UPR MSC IRB B0710118
- Conditions
- Malocclusion, Class I/II
- Keywords
- Corticotomy; MOP; Tooth movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Collaborators
- University of Zagreb
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 26 Sep 2020 (actual)
- First posted
- 10 Aug 2021 (actual)
- 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.
Corticotomy and micro-osteoperforation (MOP) have been proven to accelerate tooth movement and shorten orthodontic treatment time, compared to conventional treatment. MOP is less invasive; however, it is unclear whether it is as effective as a corticotomy. The purpose of this study was to compare the maxillary canine retraction achieved by these techniques.
Detailed description
Thirteen patients (5 females, 8 males; mean age, 18.07±6.74 years) with healthy permanent dentition requiring the extraction of maxillary first premolars were included in a split-mouth randomized clinical trial. Subjects with previous orthodontic or endodontic treatment of canines were excluded. At least 3 months post-extraction, MOPs, and corticotomies were performed distal to the canines. Mini-screws with closed-coil springs (150g) were used for canine retraction. Dental casts were attained at baseline (T0) and 3 months post-intervention (T1). Calibrated examiners measured the distances from the canine to the second premolar on both sides. A Signed-rank sum test was used to compare canine retraction achieved in 3 months (T0-T1) in two sides
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- a split-mouth randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Corticotomy | Active comparator | Procedure: Corticotomy1. A full-thickness labial mucoperiosteal flap was reflected. 2. Two vertical corticotomies (1 mesial and 1 distal to the canine) were performed . The cortical bone was cut 2 to 3 mm below the alveolar crest towards the apex until bone marrow was exposed. 3. Cortical-cancellous bone grafts (0.5cc; PuraGraft, Kingwood, TX) were placed at the corticotomy sites. 4. The mini-screws were placed. 5. A nickel-titanium (NiTi) closed-coil spring was placed and secured with a 0.014"SS ligature wire at the canine and mini-screw. A Dontrix gauge (Orthopli Corp., Philadelphia, PA) was used to measure the force (150g). |
| Micro-Osteoperforation | Experimental | Procedure: Micro-Osteoperforations1. MOPs were performed with a stainless-steel manual drill tip that had 1.6mm diameter with an adjustable depth set to 5mm (Excellerator® RT; Propel Orthodontics, Milpitas, CA). 2. Six perforations were made along 2 parallel vertical lines (each line with 3 holes spaced ~2mm apart) distal to the canine and perpendicular to the buccal cortical bone. 3. The mini-screws were placed. 4. A NiTi closed-coil spring was placed and secured with a 0.014"SS ligature wire at the canine and mini-screw. A Dontrix gauge was used to measure the force (150g). |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Healthy permanent dentition requiring the extraction of maxillary first premolars with less than 8mm of maxillary anterior crowding
Key exclusion criteria (1 listed)
- Previous orthodontic or endodontic treatment of the canines
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 |
|---|---|---|
| Micro-OsteoperforationsAlso: MOPMOPs were performed with a stainless-steel manual drill tip that had 1.6mm diameter with an adjustable depth set to 5mm (Excellerator® RT; Propel Orthodontics, Milpitas, CA). Six perforations were made along 2 parallel vertical lines (each line with 3 holes spaced ~2mm apart) distal to the canine and perpendicular to the buccal cortical bone. The mini-screws were placed. A NiTi closed-coil spring was placed and secured with a 0.014"SS ligature wire at the canine and mini-screw. A Dontrix gauge was used to measure the force (150g) | Procedure or surgery | Micro-Osteoperforation |
| CorticotomyA full-thickness labial mucoperiosteal flap was reflected. Two vertical corticotomies (1 mesial and 1 distal to the canine) were performed. The cortical bone was cut 2 to 3 mm below the alveolar crest towards the apex, until bone marrow was exposed. Cortical-cancellous bone grafts (0.5cc; PuraGraft, Kingwood, TX) were placed at the corticotomy sites. The mini-screws were placed. A nickel-titanium (NiTi) closed-coil spring was placed and secured with a 0.014"SS ligature wire at the canine and mini-screw. A Dontrix gauge (Orthopli Corp., Philadelphia, PA) was used to measure the force (150g) | Procedure or surgery | Corticotomy |
Primary outcome
Canine retraction
Time frame: 3 months
Amount of tooth movement (in mm) attained by the maxillary canines after retracting them
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 17 Aug 2021.
- Background: PubMed 29655409Li Y, Jacox LA, Little SH, Ko CC. Orthodontic tooth movement: The biology and clinical implications. Kaohsiung J Med Sci. 2018 Apr;34(4):207-214. doi: 10.1016/j.kjms.2018.01.007. Epub 2018 Feb 3.
- Background: PubMed 21300255Aboul-Ela SM, El-Beialy AR, El-Sayed KM, Selim EM, El-Mangoury NH, Mostafa YA. Miniscrew implant-supported maxillary canine retraction with and without corticotomy-facilitated orthodontics. Am J Orthod Dentofacial Orthop. 2011 Feb;139(2):252-9. doi: 10.1016/j.ajodo.2009.04.028.
- Background: PubMed 6345475Frost HM. The regional acceleratory phenomenon: a review. Henry Ford Hosp Med J. 1983;31(1):3-9. No abstract available.
- Background: PubMed 26599115Verna C. Regional Acceleratory Phenomenon. Front Oral Biol. 2016;18:28-35. doi: 10.1159/000351897. Epub 2015 Nov 24.
- Background: PubMed 31155698Aboalnaga AA, Salah Fayed MM, El-Ashmawi NA, Soliman SA. Effect of micro-osteoperforation on the rate of canine retraction: a split-mouth randomized controlled trial. Prog Orthod. 2019 Jun 3;20(1):21. doi: 10.1186/s40510-019-0274-0.
- Background: PubMed 27894545Cheung T, Park J, Lee D, Kim C, Olson J, Javadi S, Lawson G, McCabe J, Moon W, Ting K, Hong C. Ability of mini-implant-facilitated micro-osteoperforations to accelerate tooth movement in rats. Am J Orthod Dentofacial Orthop. 2016 Dec;150(6):958-967. doi: 10.1016/j.ajodo.2016.04.030.
- Background: PubMed 17465647Fischer TJ. Orthodontic treatment acceleration with corticotomy-assisted exposure of palatally impacted canines. Angle Orthod. 2007 May;77(3):417-20. doi: 10.2319/0003-3219(2007)077[0417:OTAWCE]2.0.CO;2.
- Background: PubMed 24592904Leethanakul C, Kanokkulchai S, Pongpanich S, Leepong N, Charoemratrote C. Interseptal bone reduction on the rate of maxillary canine retraction. Angle Orthod. 2014 Sep;84(5):839-45. doi: 10.2319/100613-737.1. Epub 2014 Mar 4.
- Background: PubMed 24182579Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.
- Background: PubMed 13793201AMLER MH, JOHNSON PL, SALMAN I. Histological and histochemical investigation of human alveolar socket healing in undisturbed extraction wounds. J Am Dent Assoc. 1960 Jul;61:32-44. doi: 10.14219/jada.archive.1960.0152. No abstract available.
- Background: PubMed 25329505Arreghini A, Lombardo L, Mollica F, Siciliani G. Torque expression capacity of 0.018 and 0.022 bracket slots by changing archwire material and cross section. Prog Orthod. 2014 Sep 25;15(1):53. doi: 10.1186/s40510-014-0053-x.
- Background: PubMed 23376899Pandis N, Walsh T, Polychronopoulou A, Katsaros C, Eliades T. Split-mouth designs in orthodontics: an overview with applications to orthodontic clinical trials. Eur J Orthod. 2013 Dec;35(6):783-9. doi: 10.1093/ejo/cjs108. Epub 2013 Feb 1.
- Individual participant dataSharing planned: No
Related trials for Malocclusion, Class I/II
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Effect of Early Versus Late Premolar Extraction on Orthodontic Tooth Movement
Malocclusion Class II, Malocclusion, Angle Class I
Not yet recruiting
3D Printed Occlusal Splints for Intraoperative Use
Malocclusion, Angle Class I, Malocclusion, Angle Class II
Recruiting
LLLLT vs Piezocision in Accelerating Orthodontic Canine Retraction
Malocclusion, Angle Class II, Division 1, Bimaxillary Protrusion
Active, not recruiting
A Comparative Study Between Modified Miniscrew-Assisted Rapid Palatal Expander And Modified Rapid Palatal Expander in Molar Distalization Using Cone- Beam Computed Tomography
Malocclusion, Class I/II, Crowding
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.
Augusto R Elias, DMD,MSD study director
Assitant Dean of Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro-Osteoperforations and Corticotomy in people with Malocclusion, Class I/II, run by University of Puerto Rico at 1 site in Puerto Rico.
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 1 inclusion and 1 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 17 Aug 2021. 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 Puerto Rico. 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?
Canine retraction (time frame: 3 months). 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 NCT04999150, which also lists 13 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 17 Aug 2021.