Mandibular Anterior CrowdingNCT02026258
Efficiency of Piezotome-Corticision Assisted Orthodontics
A study testing Piezotome-Corticision and Orthodontics in people with Mandibular Anterior Crowding and Piezocision, run by UConn Health at 1 site in United States.
Trial summary
The aim of this study is to evaluate the hypothesis that a piezotome-corticision procedure will have a transient acceleratory effect on the rate of tooth alignment and the overall treatment time. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mandibular Anterior Crowding, Piezocision, Pain Perception
- What is being tested?
- Piezotome-Corticision and Orthodontics
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients 18 or older
- Single arch or double arch treatment
- Non-extraction treatment in the mandibular arch
- Presence of full complement dentition from first molar to first molar
- No spaces in the mandibular arch
- Mandibular anterior irregularity index greater than 5
Show all 9Show fewer
- Patient with healthy periodontium and attachment loss of up to 2mm
- The amount of crowding should allow for bracket placement
- No therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances including elastics, lip bumpers, maxillary expansion appliances, or headgear prior to the complete alignment of mandibular anterior teeth.
Who cannot join
- Failure to provide oral and written consent to participation
- Medical problems that affect tooth movement (Refer to Appendix I)
- Presence of primary teeth in the mandibular anterior area
- Missing permanent mandibular anterior teeth
- Inability to place brackets in the anterior mandibular teeth
- Breakage of any of the mandibular anterior brackets that have not been replaced within a week
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthodontic Clinic University of Connecticut
Farmington, Connecticut, 06030
About this study
Official title: Efficiency of Piezotome-Corticision Assisted Orthodontics in Alleviating Mandibular Anterior Crowding - A Randomized Controlled Clinical Trial
The aim of this study is to evaluate the hypothesis that a piezotome-corticision procedure will have a transient acceleratory effect on the rate of tooth alignment and the overall treatment time. In addition, the subjects in the piezotome-corticision orthodontics group will experience a different level of pain, comfort, and satisfaction as opposed to the conventional orthodontics group.
Read the detailed description
This study will specifically try:
- To compare the time required to achieve complete alignment of crowded mandibular anterior teeth (canine to canine) between piezotome-corticision assisted and conventional orthodontics.
- To investigate the rate of alignment of mandibular anterior teeth at different time points until complete alignment is achieved using dental casts taken at every visit.
- To compare subject's perception of pain, comfort and satisfaction between the piezotome-corticision assisted and conventional orthodontics using two questionnaires.
Eligibility criteria includes:
- Adult patients 18 or older
- Single arch or double arch treatment
- Non-extraction treatment in the mandibular arch
- Presence of full complement dentition from first molar to first molar
- No spaces in the mandibular arch
- Mandibular anterior irregularity index greater than 5
- Patient with healthy periodontium and attachment loss of up to 2mm
- The amount of crowding should allow for bracket placement
- No therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances including elastics, lip bumpers, maxillary expansion appliances, or headgear prior to the complete alignment of mandibular anterior teeth.
Exclusion criteria includes:
- Failure to provide oral and written consent to participation
- Medical problems that affect tooth movement (Refer to Appendix I)
- Presence of primary teeth in the mandibular anterior area
- Missing permanent mandibular anterior teeth
- Inability to place brackets in the anterior mandibular teeth
- Breakage of any of the mandibular anterior brackets that have not been replaced within a week
Outcome measures
- Two outcome assessors will be calibrated in the assessment of the Little's irregularity index. The irregularity index will be measured twice by two blinded outcome assessors using a fine-tip digital caliper.
- The subjects will be instructed to record their level of pain: immediately, 1 hour, 12 hours, and 7 days after the first wire placement [76, 82]. They will be also asked to report if they had taken any pain medications, their level of ease and satisfaction with the procedure, if they would undergo this procedure again, and if they would recommend it to a friend. A 100 mm Visual Analog Scale (VAS) will be used to evaluate the level of pain, ease, and satisfaction of all the subjects, with anchors at each end of the line that read "no pain (easy, satisfied)" (0 mm) and "most pain (complicated, not satisfied)" (100 mm).
- Conditions
- Mandibular Anterior Crowding, Piezocision, Pain Perception
- Being tested
- Piezotome-Corticision, Orthodontics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezotome-CorticisionProcedure or surgery
Local anesthetic will be administered to the labial sulcus of the mandibular incisors. A scalpel will be used to make three vertical incisions through the gingiva, 4mm below the interdental papilla, interproximally between mandibular canines and lateral incisors, and central incisors on the labial aspect of the mandible. The incisions will be 4mm in length. A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin. Postoperatively, subjects will be advised to rinse with chlorhexidine mouthwash twice a day for one week and take acetaminophen as needed.
OrthodonticsDevice
Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment.
| Study group | Role | What they receive |
|---|---|---|
| Orthodontics no piezocision | Active comparator | Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated. Receives: Device: Orthodontics |
| Orthodontics with piezotome corticision | Experimental | Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated. Receives: Procedure: Piezotome-Corticision; Device: Orthodontics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days to Complete Alignment of Mandibular Anterior Teeth Based on Little's Irregularity Index
Days until complete alignment of mandibular anterior alignment was achieved after wire insertion on both groups. Complete alignment was based on Little's Irregularity index (Sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine) of less than 2mm.
Measured: From the placement of the first wire to complete alignment of mandibular anteiror teeth, assessed up to 9 months
Secondary outcomes (3)
Questionnaires Involving Pain Level
Specific questions questionnaire included:
- How much pain/discomfort at the following time points? 1) Immediately after first wire placement (T0), 2) 1 hour, (T1) 3) 12 hrs (T2) and 4) Seven days after (T3). Rated on a scale from 0-100 (No pain-Unbearable pain)
Measured: Immediate to 1 week after wire placement (T0-T3)
Questionnaire on Easiness and Satisfaction With the Procedure
Visual analogue Scale from 0-100
- Are you satisfied with your treatment? Very- Not Satisfied (0-100)
- How easy was the procedure to you? Easy-Complicated (0-100)
Measured: 4-5 weeks after first wire placement
Questionnaire Involving Pain Management and Satisfaction With the Procedure
Binomial measurement in questionnaire on medications taken and satisfaction with the procedure
- Did you take any pain medication after the procedure? Y/N (Count Yes)
- Would you undergo this procedure again? Y/N (Count Yes)
- Would you recommend this procedure to a friend? Y/N (Count Yes)
Measured: 4-5 weeks after first wire placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startDec 2011
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Mandibular Anterior 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flavio Uribe, UConn Health
- Investigators
- Flavio Uribe, DDS MDS, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026258
- Sponsor's protocol ID
- IE-12-047-2
- Status last verified
- Jul 2017
- First submitted
- 23 Dec 2013
- Last updated
- 7 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Buschang PH, Campbell PM, Ruso S. Accelerating tooth movement with corticotomies: is it possible and desirable? Semin Orthod 2012;18:286-294.
Gameiro GH, Pereira-Neto JS, Magnani MB, Nouer DF. The influence of drugs and systemic factors on orthodontic tooth movement. J Clin Orthod. 2007 Feb;41(2):73-8; quiz 71. No abstract available.
PubMed 17473406Lee WC. Experimental study of the effect of prostaglandin administration on tooth movement--with particular emphasis on the relationship to the method of PGE1 administration. Am J Orthod Dentofacial Orthop. 1990 Sep;98(3):231-41. doi: 10.1016/s0889-5406(05)81600-2.
PubMed 2403075Verna C, Dalstra M, Melsen B. The rate and the type of orthodontic tooth movement is influenced by bone turnover in a rat model. Eur J Orthod. 2000 Aug;22(4):343-52. doi: 10.1093/ejo/22.4.343.
PubMed 11029824Yamasaki K, Shibata Y, Fukuhara T. The effect of prostaglandins on experimental tooth movement in monkeys (Macaca fuscata). J Dent Res. 1982 Dec;61(12):1444-6. doi: 10.1177/00220345820610121401.
PubMed 6960050Liou EJ, Huang CS. Rapid canine retraction through distraction of the periodontal ligament. Am J Orthod Dentofacial Orthop. 1998 Oct;114(4):372-82. doi: 10.1016/s0889-5406(98)70181-7.
PubMed 9790320Ren A, Lv T, Kang N, Zhao B, Chen Y, Bai D. Rapid orthodontic tooth movement aided by alveolar surgery in beagles. Am J Orthod Dentofacial Orthop. 2007 Feb;131(2):160.e1-10. doi: 10.1016/j.ajodo.2006.05.029.
PubMed 17276852Kim SJ, Park YG, Kang SG. Effects of Corticision on paradental remodeling in orthodontic tooth movement. Angle Orthod. 2009 Mar;79(2):284-91. doi: 10.2319/020308-60.1.
PubMed 19216591Fitzpatrick BN. Corticotomy. Aust Dent J. 1980 Oct;25(5):255-8. doi: 10.1111/j.1834-7819.1980.tb05196.x.
PubMed 6936001Generson RM, Porter JM, Zell A, Stratigos GT. Combined surgical and orthodontic management of anterior open bite using corticotomy. J Oral Surg. 1978 Mar;36(3):216-9.
PubMed 272455Gantes B, Rathbun E, Anholm M. Effects on the periodontium following corticotomy-facilitated orthodontics. Case reports. J Periodontol. 1990 Apr;61(4):234-8. doi: 10.1902/jop.1990.61.4.234.
PubMed 2324923KOLE H. Surgical operations on the alveolar ridge to correct occlusal abnormalities. Oral Surg Oral Med Oral Pathol. 1959 May;12(5):515-29 concl. doi: 10.1016/0030-4220(59)90153-7. No abstract available.
PubMed 13644913Wilcko 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 11829041Chung KR, Kim SH, Lee BS. Speedy surgical-orthodontic treatment with temporary anchorage devices as an alternative to orthognathic surgery. Am J Orthod Dentofacial Orthop. 2009 Jun;135(6):787-98. doi: 10.1016/j.ajodo.2007.03.036.
PubMed 19524840Frost HM. The regional acceleratory phenomenon: a review. Henry Ford Hosp Med J. 1983;31(1):3-9. No abstract available.
PubMed 6345475
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Piezotome-Corticision Assisted Orthodontics in Alleviating Mandibular Anterior Crowding - A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02026258
- Acronym / sponsor ID
- IE-12-047-2
- Conditions
- Mandibular Anterior Crowding, Piezocision, Pain Perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 Jan 2014 (estimated)
- Results
- Posted 7 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the hypothesis that a piezotome-corticision procedure will have a transient acceleratory effect on the rate of tooth alignment and the overall treatment time. In addition, the subjects in the piezotome-corticision orthodontics group will experience a different level of pain, comfort, and satisfaction as opposed to the conventional orthodontics group.
Detailed description
This study will specifically try:
- To compare the time required to achieve complete alignment of crowded mandibular anterior teeth (canine to canine) between piezotome-corticision assisted and conventional orthodontics.
- To investigate the rate of alignment of mandibular anterior teeth at different time points until complete alignment is achieved using dental casts taken at every visit.
- To compare subject's perception of pain, comfort and satisfaction between the piezotome-corticision assisted and conventional orthodontics using two questionnaires.
Eligibility criteria includes:
- Adult patients 18 or older
- Single arch or double arch treatment
- Non-extraction treatment in the mandibular arch
- Presence of full complement dentition from first molar to first molar
- No spaces in the mandibular arch
- Mandibular anterior irregularity index greater than 5
- Patient with healthy periodontium and attachment loss of up to 2mm
- The amount of crowding should allow for bracket placement
- No therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances including elastics, lip bumpers, maxillary expansion appliances, or headgear prior to the complete alignment of mandibular anterior teeth.
Exclusion criteria includes:
- Failure to provide oral and written consent to participation
- Medical problems that affect tooth movement (Refer to Appendix I)
- Presence of primary teeth in the mandibular anterior area
- Missing permanent mandibular anterior teeth
- Inability to place brackets in the anterior mandibular teeth
- Breakage of any of the mandibular anterior brackets that have not been replaced within a week
Outcome measures
- Two outcome assessors will be calibrated in the assessment of the Little's irregularity index. The irregularity index will be measured twice by two blinded outcome assessors using a fine-tip digital caliper.
- The subjects will be instructed to record their level of pain: immediately, 1 hour, 12 hours, and 7 days after the first wire placement [76, 82]. They will be also asked to report if they had taken any pain medications, their level of ease and satisfaction with the procedure, if they would undergo this procedure again, and if they would recommend it to a friend. A 100 mm Visual Analog Scale (VAS) will be used to evaluate the level of pain, ease, and satisfaction of all the subjects, with anchors at each end of the line that read "no pain (easy, satisfied)" (0 mm) and "most pain (complicated, not satisfied)" (100 mm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthodontics no piezocision | Active comparator | Device: OrthodonticsSubjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated. |
| Orthodontics with piezotome corticision | Experimental | Procedure: Piezotome-Corticision, Device: OrthodonticsSubjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patients 18 or older
- Single arch or double arch treatment
- Non-extraction treatment in the mandibular arch
- Presence of full complement dentition from first molar to first molar
- No spaces in the mandibular arch
Key exclusion criteria (6 listed)
- Failure to provide oral and written consent to participation
- Medical problems that affect tooth movement (Refer to Appendix I)
- Presence of primary teeth in the mandibular anterior area
- Missing permanent mandibular anterior teeth
- Inability to place brackets in the anterior mandibular teeth
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 |
|---|---|---|
| Piezotome-CorticisionLocal anesthetic will be administered to the labial sulcus of the mandibular incisors. A scalpel will be used to make three vertical incisions through the gingiva, 4mm below the interdental papilla, interproximally between mandibular canines and lateral incisors, and central incisors on the labial aspect of the mandible. The incisions will be 4mm in length. A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin. Postoperatively, subjects will be advised to rinse with chlorhexidine mouthwash twice a day for one week and take acetaminophen as needed. | Procedure or surgery | Orthodontics with piezotome corticision |
| OrthodonticsSubjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. | Device | Orthodontics no piezocision, Orthodontics with piezotome corticision |
Primary outcome
Number of Days to Complete Alignment of Mandibular Anterior Teeth Based on Little's Irregularity Index
Time frame: From the placement of the first wire to complete alignment of mandibular anteiror teeth, assessed up to 9 months
Days until complete alignment of mandibular anterior alignment was achieved after wire insertion on both groups. Complete alignment was based on Little's Irregularity index (Sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine) of less than 2mm.
3 secondary outcomes
Questionnaires Involving Pain Level
Time frame: Immediate to 1 week after wire placement (T0-T3)
Questionnaire on Easiness and Satisfaction With the Procedure
Time frame: 4-5 weeks after first wire placement
Questionnaire Involving Pain Management and Satisfaction With the Procedure
Time frame: 4-5 weeks after first wire placement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundBuschang PH, Campbell PM, Ruso S. Accelerating tooth movement with corticotomies: is it possible and desirable? Semin Orthod 2012;18:286-294.
- Background: PubMed 17473406Gameiro GH, Pereira-Neto JS, Magnani MB, Nouer DF. The influence of drugs and systemic factors on orthodontic tooth movement. J Clin Orthod. 2007 Feb;41(2):73-8; quiz 71. No abstract available.
- Background: PubMed 2403075Lee WC. Experimental study of the effect of prostaglandin administration on tooth movement--with particular emphasis on the relationship to the method of PGE1 administration. Am J Orthod Dentofacial Orthop. 1990 Sep;98(3):231-41. doi: 10.1016/s0889-5406(05)81600-2.
- Background: PubMed 11029824Verna C, Dalstra M, Melsen B. The rate and the type of orthodontic tooth movement is influenced by bone turnover in a rat model. Eur J Orthod. 2000 Aug;22(4):343-52. doi: 10.1093/ejo/22.4.343.
- Background: PubMed 6960050Yamasaki K, Shibata Y, Fukuhara T. The effect of prostaglandins on experimental tooth movement in monkeys (Macaca fuscata). J Dent Res. 1982 Dec;61(12):1444-6. doi: 10.1177/00220345820610121401.
- Background: PubMed 9790320Liou EJ, Huang CS. Rapid canine retraction through distraction of the periodontal ligament. Am J Orthod Dentofacial Orthop. 1998 Oct;114(4):372-82. doi: 10.1016/s0889-5406(98)70181-7.
- Background: PubMed 17276852Ren A, Lv T, Kang N, Zhao B, Chen Y, Bai D. Rapid orthodontic tooth movement aided by alveolar surgery in beagles. Am J Orthod Dentofacial Orthop. 2007 Feb;131(2):160.e1-10. doi: 10.1016/j.ajodo.2006.05.029.
- Background: PubMed 19216591Kim SJ, Park YG, Kang SG. Effects of Corticision on paradental remodeling in orthodontic tooth movement. Angle Orthod. 2009 Mar;79(2):284-91. doi: 10.2319/020308-60.1.
- Background: PubMed 6936001Fitzpatrick BN. Corticotomy. Aust Dent J. 1980 Oct;25(5):255-8. doi: 10.1111/j.1834-7819.1980.tb05196.x.
- Background: PubMed 272455Generson RM, Porter JM, Zell A, Stratigos GT. Combined surgical and orthodontic management of anterior open bite using corticotomy. J Oral Surg. 1978 Mar;36(3):216-9.
- Background: PubMed 2324923Gantes B, Rathbun E, Anholm M. Effects on the periodontium following corticotomy-facilitated orthodontics. Case reports. J Periodontol. 1990 Apr;61(4):234-8. doi: 10.1902/jop.1990.61.4.234.
- Background: PubMed 13644913KOLE H. Surgical operations on the alveolar ridge to correct occlusal abnormalities. Oral Surg Oral Med Oral Pathol. 1959 May;12(5):515-29 concl. doi: 10.1016/0030-4220(59)90153-7. No abstract available.
- Individual participant dataSharing planned: Yes
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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.
Flavio Uribe, DDS MDS principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezotome-Corticision and Orthodontics in people with Mandibular Anterior Crowding and Piezocision, run by UConn Health at 1 site in United States.
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 9 inclusion and 6 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 7 Aug 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 7 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Days to Complete Alignment of Mandibular Anterior Teeth Based on Little's Irregularity Index (time frame: From the placement of the first wire to complete alignment of mandibular anteiror teeth, assessed up to 9 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 NCT02026258, which also lists 34 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 7 Aug 2017.