Orthodontic Anchorage ProceduresNCT02644811
Miniscrews as Anchorage Device for Orthodontic Treatment
A study testing Topical anesthesia (buccal and palatal), Local anesthesia (buccal and palatal) and Extraction of the maxillary first premolars in people with Orthodontic Anchorage Procedures and Orthodontic Space Closure, run by Region Gävleborg at 1 site in Sweden.
Trial summary
The purpose of this trial is to study and compare two different anchorage techniques. Adolescent patients in need for orthodontic treatment are randomized into Group A and B. Both groups are treated with extractions of the maxillary first premolars and fixed appliance. Read more about this study
- Who is it for?
- Ages 11 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Anchorage Procedures, Orthodontic Space Closure
- What is being tested?
- Topical anesthesia (buccal and palatal), Local anesthesia (buccal and palatal) and Extraction of the maxillary first premolars
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2009to 21 Sep 2018
- 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 11 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents in need of orthodontic treatment with fixed appliance including extractions of the maxillary first premolars
- Need for Anchorage reinforcement
- Permanent dentition including the maxillary second molars in occlusion (DS4M2 according to Björk)
- Regular dental care in Sweden since the age of three.
Who cannot join
- Experience of previous orthodontic treatment
- Need for orthognathic surgery
- Need for maximum anchorage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Miniscrews as Anchorage Device for Orthodontic Treatment - Randomized Controlled Trials on Anchorage Capacity, Cost Efficiency and Patient Acceptance
The purpose of this trial is to study and compare two different anchorage techniques. Adolescent patients in need for orthodontic treatment are randomized into Group A and B. Both groups are treated with extractions of the maxillary first premolars and fixed appliance. Anchorage is reinforced by miniscrews in Group A and by molarblock in Group B.
The hypotheses are:
- that placement of miniscrews does not cause more pain or discomfort than premolar extractions
- that molarblock provides increase of anchorage
- that miniscrews have a better anchorage capacity than molarblock
- that miniscrews are more cost-efficient than conventional anchorage techniques
Read the detailed description
Participants are recruited from the orthodontic specialist clinic in Gävle, Sweden. After informed consent participants are randomized into Group A and B. The treatment starts with extractions of the maxillary first premolars. Extractions are performed by the participants´ general practitioner. Orthodontic treatment starts after the tooth extractions.
All participants get treatment with fixed appliance according to the straight wire concept (3M Victory brackets, .022 slot size, McLaughlin-Bennet-Trevesi prescription). The recommended wire sequence is: .016 Heat Activated Nickel Titanium, .019x.025 Heat Activated Nickel Titanium, .019x.025 Stainless Steel. Treatment time is about two years.
The following measurements are taken at:
T0 (Before treatment start): Study models, baseline questionnaire,
T1 (after tooth extractions, before the orthodontic treatment): Study models, cephalographic x-ray, questionnaire at the evening after tooth extractions, questionnaire one week after tooth extractions.
T2 (After miniscrew placement (Group A), Before space closure): Study models, cephalographic x-ray, questionnaire at the evening after miniscrew placement, questionnaire one week after miniscrew placement.
T3 (After space closure and miniscrew removal): Study models, cephalographic x-ray, questionnaire after screw removal
- Being tested
- Topical anesthesia (buccal and palatal), Local anesthesia (buccal and palatal), Extraction of the maxillary first premolars, Topical anesthesia (buccal), Local anesthesia (buccal)
- Keywords
- Miniscrew, Temporary anchorage device (TAD), mini-implants, Miniscrew implant (MSI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical anesthesia (buccal and palatal)Drug
Also called Anesthesic Jelly (buccal and palatal)
Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva.
Local anesthesia (buccal and palatal)Drug
Also called Injection (buccal and palatal)
Injection of 1,5 ml Xylocaine Dental Adrenaline (Lidocaine hydrochloride 20 mg/ml, adrenaline 12.5 µg/ml, Dentsply Pharmaceutical, Weybridge, Surrey, UK).
Extraction of the maxillary first premolarsProcedure or surgery
Careful extraction of the maxillary first premolars after mobilization.
Topical anesthesia (buccal)Drug
Also called Anesthesic Jelly (buccal)
Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva.
Local anesthesia (buccal)Drug
Also called Injection (buccal)
Injection of 0.3 ml Xylocaine Dental Adrenaline (Lidocaine hydrochloride 20 mg/ml, adrenaline 12.5 µg/ml, Dentsply Pharmaceutical, Weybridge, Surrey, UK).
MolarblockDevice
Molarblock is a Stainless steel ligature connecting the maxillary second premolar with the maxillary first and second molar.
Spider Screw K1 short neckDevice
Also called Temporary anchorage device, TAD, Orthodontic mini-implant
The Spider Screw K1 (Health Development Company, Sarcedo, Italy) is a self-drilling and self-tapping screw. Short neck screws (SCR-1508 and SCR-1510) with a diameter of 1.5 mm and length 8 or 10 mm are used.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Miniscrews | Experimental | Topical anesthesia (buccal and palatal) followed by local anesthesia (buccal and palatal). Extraction of the maxillary first premolars.
Fixed appliance in the maxilla or maxilla and mandible.
Anchorage reinforcement with miniscrews (Spider Screw K1 short neck). Miniscrews are placed buccally between the maxillary second premolar and the first molar after topical anesthesia (buccal) and injection (buccal). Miniscrews are placed when space closure starts. Space closure is performed as en masse retraction. Miniscrew are immediately loaded with 150g Nickel Titanium coil springs. Receives: Drug: Topical anesthesia (buccal and palatal); Drug: Local anesthesia (buccal and palatal); Procedure: Extraction of the maxillary first premolars; Drug: Topical anesthesia (buccal); Drug: Local anesthesia (buccal); Device: Spider Screw K1 short neck |
| Group B - Molarblock | Active comparator | Topical anesthesia (buccal and palatal) followed by local anesthesia (buccal and palatal. Extraction of the maxillary first premolars.
Fixed appliance in the maxilla or maxilla and mandible.
Anchorage reinforcement with molarblocks - a Stainless steel ligature connecting the maxillary second premolar with the maxillary first and second molar. Molarblocks are installed from the beginning of leveling and alignment. Space closure is performed as en masse retraction with type one active tie-backs. Receives: Drug: Topical anesthesia (buccal and palatal); Drug: Local anesthesia (buccal and palatal); Procedure: Extraction of the maxillary first premolars; Device: Molarblock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tooth Position of the Maxillary Molars During Space Closure
Tooth movement is assessed in millimeters using superimposition of study models and lateral cephalograms.
Measured: Through Space Closure (T2-T3), an average of 9 months
Secondary outcomes (3)
Experience of Pain and Discomfort
Experiences of pain and discomfort are examined with validated self-report questionnaires.
Measured: Baseline, the evening after tooth extractions, one week after tooth extractions, the evening after miniscrew placement, one week after miniscrew placement
Change in Tooth Position of the Maxillary Molars During Levelling and Alignment
Tooth movement is assessed in millimeters using superimposition of study models and lateral cephalograms.
Measured: Through Levelling and Alignment (T1-T2), an average of 9 months
Societal Costs
Societal costs are the sum of direct and indirect treatment costs. Direct costs are treatment time in the clinic and used material. Indirect costs are travel costs and costs for parents following the participant to the clinic.
Measured: Through Study Completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startNov 2009
- Primary completionJul 2018
- Study completion21 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Anchorage ProceduresStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Gävleborg
- Sponsor type
- University, hospital or other
- Collaborators
- Malmö University, Uppsala University, Swedish Dental Associations Scientific Funds
- Responsible party
- Principal investigator, Niels Ganzer, Region Gävleborg
- Investigators
- Lars Bondemark, Professor, Study chair, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644811
- Sponsor's protocol ID
- CFUG-479851
- Status last verified
- Feb 2019
- First submitted
- 18 Dec 2015
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Feldmann I, List T, John MT, Bondemark L. Reliability of a questionnaire assessing experiences of adolescents in orthodontic treatment. Angle Orthod. 2007 Mar;77(2):311-7. doi: 10.2319/0003-3219(2007)077[0311:ROAQAE]2.0.CO;2.
PubMed 17319767Upadhyay M, Yadav S, Nanda R. Biomechanics of incisor retraction with mini-implant anchorage. J Orthod. 2014 Sep;41 Suppl 1:S15-23. doi: 10.1179/1465313314Y.0000000114.
PubMed 25138361Upadhyay M, Yadav S, Patil S. Mini-implant anchorage for en-masse retraction of maxillary anterior teeth: a clinical cephalometric study. Am J Orthod Dentofacial Orthop. 2008 Dec;134(6):803-10. doi: 10.1016/j.ajodo.2006.10.025.
PubMed 19061808Lehnen S, McDonald F, Bourauel C, Baxmann M. Patient expectations, acceptance and preferences in treatment with orthodontic mini-implants. A randomly controlled study. Part I: insertion techniques. J Orofac Orthop. 2011 Mar;72(2):93-102. doi: 10.1007/s00056-011-0013-8. English, German.
PubMed 21503849Feldmann I, List T, Feldmann H, Bondemark L. Pain intensity and discomfort following surgical placement of orthodontic anchoring units and premolar extraction: a randomized controlled trial. Angle Orthod. 2007 Jul;77(4):578-85. doi: 10.2319/062506-257.1.
PubMed 17605489Feldmann I, List T, Bondemark L. Orthodontic anchoring techniques and its influence on pain, discomfort, and jaw function--a randomized controlled trial. Eur J Orthod. 2012 Feb;34(1):102-8. doi: 10.1093/ejo/cjq171. Epub 2011 Feb 7.
PubMed 21300723Melsen B, Costa A. Immediate loading of implants used for orthodontic anchorage. Clin Orthod Res. 2000 Feb;3(1):23-8. doi: 10.1034/j.1600-0544.2000.030105.x.
PubMed 11168281Lai EH, Yao CC, Chang JZ, Chen I, Chen YJ. Three-dimensional dental model analysis of treatment outcomes for protrusive maxillary dentition: comparison of headgear, miniscrew, and miniplate skeletal anchorage. Am J Orthod Dentofacial Orthop. 2008 Nov;134(5):636-45. doi: 10.1016/j.ajodo.2007.05.017.
PubMed 18984395Papadopoulos MA, Tarawneh F. The use of miniscrew implants for temporary skeletal anchorage in orthodontics: a comprehensive review. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 May;103(5):e6-15. doi: 10.1016/j.tripleo.2006.11.022. Epub 2007 Feb 21.
PubMed 17317235Ganzer N, Feldmann I, Petren S, Bondemark L. A cost-effectiveness analysis of anchorage reinforcement with miniscrews and molar blocks in adolescents: a randomized controlled trial. Eur J Orthod. 2019 Mar 29;41(2):180-187. doi: 10.1093/ejo/cjy041.
PubMed 30668660Ganzer N, Feldmann I, Bondemark L. Anchorage reinforcement with miniscrews and molar blocks in adolescents: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2018 Dec;154(6):758-767. doi: 10.1016/j.ajodo.2018.07.011.
PubMed 30477773
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Miniscrews as Anchorage Device for Orthodontic Treatment - Randomized Controlled Trials on Anchorage Capacity, Cost Efficiency and Patient Acceptance
- ClinicalTrials.gov ID
- NCT02644811
- Acronym / sponsor ID
- CFUG-479851
- Keywords
- Miniscrew, Temporary anchorage device (TAD), mini-implants, Miniscrew implant (MSI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Region GävleborgUniversity, hospital or other
- Collaborators
- Malmö University, Uppsala University, Swedish Dental Associations Scientific Funds
- Study start
- Nov 2009 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- 21 Sep 2018 (actual)
- First posted
- 1 Jan 2016 (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.
The purpose of this trial is to study and compare two different anchorage techniques. Adolescent patients in need for orthodontic treatment are randomized into Group A and B. Both groups are treated with extractions of the maxillary first premolars and fixed appliance. Anchorage is reinforced by miniscrews in Group A and by molarblock in Group B.
The hypotheses are:
- that placement of miniscrews does not cause more pain or discomfort than premolar extractions
- that molarblock provides increase of anchorage
- that miniscrews have a better anchorage capacity than molarblock
- that miniscrews are more cost-efficient than conventional anchorage techniques
Detailed description
Participants are recruited from the orthodontic specialist clinic in Gävle, Sweden. After informed consent participants are randomized into Group A and B. The treatment starts with extractions of the maxillary first premolars. Extractions are performed by the participants´ general practitioner. Orthodontic treatment starts after the tooth extractions.
All participants get treatment with fixed appliance according to the straight wire concept (3M Victory brackets, .022 slot size, McLaughlin-Bennet-Trevesi prescription). The recommended wire sequence is: .016 Heat Activated Nickel Titanium, .019x.025 Heat Activated Nickel Titanium, .019x.025 Stainless Steel. Treatment time is about two years.
The following measurements are taken at:
T0 (Before treatment start): Study models, baseline questionnaire,
T1 (after tooth extractions, before the orthodontic treatment): Study models, cephalographic x-ray, questionnaire at the evening after tooth extractions, questionnaire one week after tooth extractions.
T2 (After miniscrew placement (Group A), Before space closure): Study models, cephalographic x-ray, questionnaire at the evening after miniscrew placement, questionnaire one week after miniscrew placement.
T3 (After space closure and miniscrew removal): Study models, cephalographic x-ray, questionnaire after screw removal
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Miniscrews | Experimental | Drug: Topical anesthesia (buccal and palatal), Drug: Local anesthesia (buccal and palatal), Procedure: Extraction of the maxillary first premolars, Drug: Topical anesthesia (buccal), Drug: Local anesthesia (buccal), Device: Spider Screw K1 short neckTopical anesthesia (buccal and palatal) followed by local anesthesia (buccal and palatal). Extraction of the maxillary first premolars. Fixed appliance in the maxilla or maxilla and mandible. Anchorage reinforcement with miniscrews (Spider Screw K1 short neck). Miniscrews are placed buccally between the maxillary second premolar and the first molar after topical anesthesia (buccal) and injection (buccal). Miniscrews are placed when space closure starts. Space closure is performed as en masse retraction. Miniscrew are immediately loaded with 150g Nickel Titanium coil springs. |
| Group B - Molarblock | Active comparator | Drug: Topical anesthesia (buccal and palatal), Drug: Local anesthesia (buccal and palatal), Procedure: Extraction of the maxillary first premolars, Device: MolarblockTopical anesthesia (buccal and palatal) followed by local anesthesia (buccal and palatal. Extraction of the maxillary first premolars. Fixed appliance in the maxilla or maxilla and mandible. Anchorage reinforcement with molarblocks - a Stainless steel ligature connecting the maxillary second premolar with the maxillary first and second molar. Molarblocks are installed from the beginning of leveling and alignment. Space closure is performed as en masse retraction with type one active tie-backs. |
Who may qualify
- Ages
- 11 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adolescents in need of orthodontic treatment with fixed appliance including extractions of the maxillary first premolars
- Need for Anchorage reinforcement
- Permanent dentition including the maxillary second molars in occlusion (DS4M2 according to Björk)
- Regular dental care in Sweden since the age of three.
Key exclusion criteria (3 listed)
- Experience of previous orthodontic treatment
- Need for orthognathic surgery
- Need for maximum anchorage.
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 |
|---|---|---|
| Topical anesthesia (buccal and palatal)Also: Anesthesic Jelly (buccal and palatal)Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva. | Drug | Group A - Miniscrews, Group B - Molarblock |
| Local anesthesia (buccal and palatal)Also: Injection (buccal and palatal)Injection of 1,5 ml Xylocaine Dental Adrenaline (Lidocaine hydrochloride 20 mg/ml, adrenaline 12.5 µg/ml, Dentsply Pharmaceutical, Weybridge, Surrey, UK). | Drug | Group A - Miniscrews, Group B - Molarblock |
| Extraction of the maxillary first premolarsCareful extraction of the maxillary first premolars after mobilization. | Procedure or surgery | Group A - Miniscrews, Group B - Molarblock |
| Topical anesthesia (buccal)Also: Anesthesic Jelly (buccal)Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva. | Drug | Group A - Miniscrews |
| Local anesthesia (buccal)Also: Injection (buccal)Injection of 0.3 ml Xylocaine Dental Adrenaline (Lidocaine hydrochloride 20 mg/ml, adrenaline 12.5 µg/ml, Dentsply Pharmaceutical, Weybridge, Surrey, UK). | Drug | Group A - Miniscrews |
| MolarblockMolarblock is a Stainless steel ligature connecting the maxillary second premolar with the maxillary first and second molar. | Device | Group B - Molarblock |
| Spider Screw K1 short neckAlso: Temporary anchorage device, TAD, Orthodontic mini-implantThe Spider Screw K1 (Health Development Company, Sarcedo, Italy) is a self-drilling and self-tapping screw. Short neck screws (SCR-1508 and SCR-1510) with a diameter of 1.5 mm and length 8 or 10 mm are used. | Device | Group A - Miniscrews |
Primary outcome
Change in Tooth Position of the Maxillary Molars During Space Closure
Time frame: Through Space Closure (T2-T3), an average of 9 months
Tooth movement is assessed in millimeters using superimposition of study models and lateral cephalograms.
3 secondary outcomes
Experience of Pain and Discomfort
Time frame: Baseline, the evening after tooth extractions, one week after tooth extractions, the evening after miniscrew placement, one week after miniscrew placement
Change in Tooth Position of the Maxillary Molars During Levelling and Alignment
Time frame: Through Levelling and Alignment (T1-T2), an average of 9 months
Societal Costs
Time frame: Through Study Completion, an average of 2 years
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 27 Feb 2019.
- Background: PubMed 17319767Feldmann I, List T, John MT, Bondemark L. Reliability of a questionnaire assessing experiences of adolescents in orthodontic treatment. Angle Orthod. 2007 Mar;77(2):311-7. doi: 10.2319/0003-3219(2007)077[0311:ROAQAE]2.0.CO;2.
- Background: PubMed 25138361Upadhyay M, Yadav S, Nanda R. Biomechanics of incisor retraction with mini-implant anchorage. J Orthod. 2014 Sep;41 Suppl 1:S15-23. doi: 10.1179/1465313314Y.0000000114.
- Background: PubMed 19061808Upadhyay M, Yadav S, Patil S. Mini-implant anchorage for en-masse retraction of maxillary anterior teeth: a clinical cephalometric study. Am J Orthod Dentofacial Orthop. 2008 Dec;134(6):803-10. doi: 10.1016/j.ajodo.2006.10.025.
- Background: PubMed 21503849Lehnen S, McDonald F, Bourauel C, Baxmann M. Patient expectations, acceptance and preferences in treatment with orthodontic mini-implants. A randomly controlled study. Part I: insertion techniques. J Orofac Orthop. 2011 Mar;72(2):93-102. doi: 10.1007/s00056-011-0013-8. English, German.
- Background: PubMed 17605489Feldmann I, List T, Feldmann H, Bondemark L. Pain intensity and discomfort following surgical placement of orthodontic anchoring units and premolar extraction: a randomized controlled trial. Angle Orthod. 2007 Jul;77(4):578-85. doi: 10.2319/062506-257.1.
- Background: PubMed 21300723Feldmann I, List T, Bondemark L. Orthodontic anchoring techniques and its influence on pain, discomfort, and jaw function--a randomized controlled trial. Eur J Orthod. 2012 Feb;34(1):102-8. doi: 10.1093/ejo/cjq171. Epub 2011 Feb 7.
- Background: PubMed 11168281Melsen B, Costa A. Immediate loading of implants used for orthodontic anchorage. Clin Orthod Res. 2000 Feb;3(1):23-8. doi: 10.1034/j.1600-0544.2000.030105.x.
- Background: PubMed 18984395Lai EH, Yao CC, Chang JZ, Chen I, Chen YJ. Three-dimensional dental model analysis of treatment outcomes for protrusive maxillary dentition: comparison of headgear, miniscrew, and miniplate skeletal anchorage. Am J Orthod Dentofacial Orthop. 2008 Nov;134(5):636-45. doi: 10.1016/j.ajodo.2007.05.017.
- Background: PubMed 17317235Papadopoulos MA, Tarawneh F. The use of miniscrew implants for temporary skeletal anchorage in orthodontics: a comprehensive review. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 May;103(5):e6-15. doi: 10.1016/j.tripleo.2006.11.022. Epub 2007 Feb 21.
- Derived from this study: PubMed 30668660Ganzer N, Feldmann I, Petren S, Bondemark L. A cost-effectiveness analysis of anchorage reinforcement with miniscrews and molar blocks in adolescents: a randomized controlled trial. Eur J Orthod. 2019 Mar 29;41(2):180-187. doi: 10.1093/ejo/cjy041.
- Derived from this study: PubMed 30477773Ganzer N, Feldmann I, Bondemark L. Anchorage reinforcement with miniscrews and molar blocks in adolescents: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2018 Dec;154(6):758-767. doi: 10.1016/j.ajodo.2018.07.011.
- Individual participant dataSharing planned: No
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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.
Lars Bondemark, Professor study chair
Malmö University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical anesthesia (buccal and palatal), Local anesthesia (buccal and palatal) and Extraction of the maxillary first premolars in people with Orthodontic Anchorage Procedures and Orthodontic Space Closure, run by Region Gävleborg at 1 site in Sweden.
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 4 inclusion and 3 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 27 Feb 2019. 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 Sweden. 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?
Change in Tooth Position of the Maxillary Molars During Space Closure (time frame: Through Space Closure (T2-T3), an average of 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 NCT02644811, which also lists 11 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 27 Feb 2019.