Miniscrews as Anchorage Device for Orthodontic Treatment

Study Overview
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Brief Summary
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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: 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
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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

Official Title
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Miniscrews as Anchorage Device for Orthodontic Treatment - Randomized Controlled Trials on Anchorage Capacity, Cost Efficiency and Patient Acceptance

Conditions
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Orthodontic Anchorage Procedures, Orthodontic Space Closure

Intervention / Treatment
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* 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: Molarblock
* Device: Spider Screw K1 short neck


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Experience of previous orthodontic treatment Need for orthognathic surgery Need for maximum anchorage.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A - Miniscrews<br>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. | Drug: Topical anesthesia (buccal and palatal)<br>* Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva.<br>* Other names: Anesthesic Jelly (buccal and palatal);Drug: Local anesthesia (buccal and palatal)<br>* Injection of 1,5 ml Xylocaine Dental Adrenaline (Lidocaine hydrochloride 20 mg/ml, adrenaline 12.5 µg/ml, Dentsply Pharmaceutical, Weybridge, Surrey, UK).<br>* Other names: Injection (buccal and palatal);Procedure: Extraction of the maxillary first premolars<br>* Careful extraction of the maxillary first premolars after mobilization.<br>Drug: Topical anesthesia (buccal)<br>* Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva.<br>* Other names: Anesthesic Jelly (buccal);Drug: Local anesthesia (buccal)<br>* Injection of 0.3 ml Xylocaine Dental Adrenaline (Lidocaine hydrochloride 20 mg/ml, adrenaline 12.5 µg/ml, Dentsply Pharmaceutical, Weybridge, Surrey, UK).<br>* Other names: Injection (buccal);Device: Spider Screw K1 short neck<br>* 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.<br>* Other names: Orthodontic mini-implant;|
| Active Comparator: Group B - Molarblock<br>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. | Drug: Topical anesthesia (buccal and palatal)<br>* Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva.<br>* Other names: Anesthesic Jelly (buccal and palatal);Drug: Local anesthesia (buccal and palatal)<br>* Injection of 1,5 ml Xylocaine Dental Adrenaline (Lidocaine hydrochloride 20 mg/ml, adrenaline 12.5 µg/ml, Dentsply Pharmaceutical, Weybridge, Surrey, UK).<br>* Other names: Injection (buccal and palatal);Procedure: Extraction of the maxillary first premolars<br>* Careful extraction of the maxillary first premolars after mobilization.<br>Device: Molarblock<br>* Molarblock is a Stainless steel ligature connecting the maxillary second premolar with the maxillary first and second molar.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Miniscrew, Temporary anchorage device (TAD), mini-implants, Miniscrew implant (MSI)