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| Name | Class |
|---|---|
| Malmö University | OTHER |
| Uppsala University | OTHER |
| Swedish Dental Associations Scientific Funds | UNKNOWN |
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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical anesthesia (buccal and palatal) | Drug | Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through Space Closure (T2-T3), an average of 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Experience of Pain and Discomfort | Experiences of pain and discomfort are examined with validated self-report questionnaires. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Bondemark, Professor | Malmö University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Specialisttandvården Ortodonti | Gävle | Gävleborg County | 80102 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17319767 | Background | 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. | |
| 25138361 | Background | 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. |
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| Local anesthesia (buccal and palatal) | Drug | Injection of 1,5 ml Xylocaine Dental Adrenaline (Lidocaine hydrochloride 20 mg/ml, adrenaline 12.5 µg/ml, Dentsply Pharmaceutical, Weybridge, Surrey, UK). |
|
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| Extraction of the maxillary first premolars | Procedure | Careful extraction of the maxillary first premolars after mobilization. |
|
| Topical anesthesia (buccal) | Drug | Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva. |
|
|
| Local anesthesia (buccal) | Drug | Injection of 0.3 ml Xylocaine Dental Adrenaline (Lidocaine hydrochloride 20 mg/ml, adrenaline 12.5 µg/ml, Dentsply Pharmaceutical, Weybridge, Surrey, UK). |
|
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| Molarblock | Device | Molarblock is a Stainless steel ligature connecting the maxillary second premolar with the maxillary first and second molar. |
|
| Spider Screw K1 short neck | Device | 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. |
|
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Tooth movement is assessed in millimeters using superimposition of study models and lateral cephalograms. |
| 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. | Through Study Completion, an average of 2 years |
| 19061808 | Background | 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. |
| 21503849 | Background | 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. |
| 17605489 | Background | 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. |
| 21300723 | Background | 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. |
| 11168281 | Background | 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. |
| 18984395 | Background | 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. |
| 17317235 | Background | 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. |
| 30668660 | Derived | 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. |
| 30477773 | Derived | 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. |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000772 | Anesthesia, Local |
| D007267 | Injections |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D000765 | Anesthesia, Conduction |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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