Miniscrews as Anchorage Device for Orthodontic Treatment
NCT ID: NCT02644811
Last Updated: 2019-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2009-11-30
2018-09-21
Brief Summary
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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
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A - Miniscrews
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.
Topical anesthesia (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)
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 premolars
Careful extraction of the maxillary first premolars after mobilization.
Topical anesthesia (buccal)
Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva.
Local anesthesia (buccal)
Injection of 0.3 ml Xylocaine Dental Adrenaline (Lidocaine hydrochloride 20 mg/ml, adrenaline 12.5 µg/ml, Dentsply Pharmaceutical, Weybridge, Surrey, UK).
Spider Screw K1 short neck
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.
Group B - Molarblock
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.
Topical anesthesia (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)
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 premolars
Careful extraction of the maxillary first premolars after mobilization.
Molarblock
Molarblock is a Stainless steel ligature connecting the maxillary second premolar with the maxillary first and second molar.
Interventions
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Topical anesthesia (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)
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 premolars
Careful extraction of the maxillary first premolars after mobilization.
Topical anesthesia (buccal)
Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva.
Local anesthesia (buccal)
Injection of 0.3 ml Xylocaine Dental Adrenaline (Lidocaine hydrochloride 20 mg/ml, adrenaline 12.5 µg/ml, Dentsply Pharmaceutical, Weybridge, Surrey, UK).
Molarblock
Molarblock is a Stainless steel ligature connecting the maxillary second premolar with the maxillary first and second molar.
Spider Screw K1 short neck
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Need for orthognathic surgery
* Need for maximum anchorage.
11 Years
20 Years
ALL
Yes
Sponsors
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Malmö University
OTHER
Department of Research and Development, County Council of Gavleborg and Uppsala University
UNKNOWN
Swedish Dental Associations Scientific Funds
UNKNOWN
Thuréus Foundation for the Promotion of Dental Science, Uppsala University, Sweden
UNKNOWN
Region Gävleborg
OTHER
Responsible Party
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Niels Ganzer
DDS, Senior Consultant Orthodontist
Principal Investigators
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Lars Bondemark, Professor
Role: STUDY_CHAIR
Malmö University
Locations
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Specialisttandvården Ortodonti
Gävle, Gävleborg County, Sweden
Countries
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References
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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.
Upadhyay 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.
Upadhyay 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.
Lehnen 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.
Feldmann 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.
Feldmann 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.
Melsen 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.
Lai 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.
Papadopoulos 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.
Ganzer 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.
Ganzer 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.
Other Identifiers
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CFUG-479851
Identifier Type: -
Identifier Source: org_study_id
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