Miniscrews as Anchorage Device for Orthodontic Treatment
- Conditions
- Orthodontic Anchorage ProceduresOrthodontic Space Closure
- Interventions
- Drug: Topical anesthesia (buccal and palatal)Drug: Local anesthesia (buccal and palatal)Procedure: Extraction of the maxillary first premolarsDevice: MolarblockDrug: Topical anesthesia (buccal)Drug: Local anesthesia (buccal)Device: Spider Screw K1 short neck
- Registration Number
- NCT02644811
- Lead Sponsor
- Region Gävleborg
- Brief 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. 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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.
- Experience of previous orthodontic treatment
- Need for orthognathic surgery
- Need for maximum anchorage.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A - Miniscrews Local anesthesia (buccal and palatal) 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 A - Miniscrews Extraction of the maxillary first premolars 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 Topical anesthesia (buccal and palatal) 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. Group A - Miniscrews Spider Screw K1 short neck 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 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. Group A - Miniscrews Topical anesthesia (buccal and palatal) 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 Extraction of the maxillary first premolars 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. Group A - Miniscrews Topical anesthesia (buccal) 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 A - Miniscrews Local anesthesia (buccal) 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 Local anesthesia (buccal and palatal) 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.
- Primary Outcome Measures
Name Time Method Change in Tooth Position of the Maxillary Molars During Space Closure Through Space Closure (T2-T3), an average of 9 months Tooth movement is assessed in millimeters using superimposition of study models and lateral cephalograms.
- Secondary Outcome Measures
Name Time Method Experience of Pain and Discomfort Baseline, the evening after tooth extractions, one week after tooth extractions, the evening after miniscrew placement, one week after miniscrew placement Experiences of pain and discomfort are examined with validated self-report questionnaires.
Change in Tooth Position of the Maxillary Molars During Levelling and Alignment Through Levelling and Alignment (T1-T2), an average of 9 months Tooth movement is assessed in millimeters using superimposition of study models and lateral cephalograms.
Societal Costs Through Study Completion, an average of 2 years 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.
Trial Locations
- Locations (1)
Specialisttandvården Ortodonti
🇸🇪Gävle, Gävleborgs Län, Sweden