NCT02644811

Miniscrews as Anchorage Device for Orthodontic Treatment

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Region Gävleborg · Academic / Other
• Sex: All
• Age: 11 Years – 20 Years
• Healthy volunteers: Accepted

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

Conditions

• Orthodontic Anchorage Procedures
• Orthodontic Space Closure

Interventions

Type	Name	Description
DRUG	Topical anesthesia (buccal and palatal)	Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva.
DRUG	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).
PROCEDURE	Extraction of the maxillary first premolars	Careful extraction of the maxillary first premolars after mobilization.
DRUG	Topical anesthesia (buccal)	Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva.
DRUG	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).
DEVICE	Molarblock	Molarblock is a Stainless steel ligature connecting the maxillary second premolar with the maxillary first and second molar.
DEVICE	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.

Timeline

• Start date: 2009-11-01
• Primary completion: 2018-07-01
• Completion: 2018-09-21
• First posted: 2016-01-01
• Last updated: 2019-02-27

Locations

1 site across 1 country: Sweden