Overview

This trial is active, not recruiting.

Conditions orthodontic anchorage procedures, orthodontic space closure
Treatments topical anesthesia (buccal and palatal), local anesthesia (buccal and palatal), extraction of the maxillary first premolars, topical anesthesia (buccal), local anesthesia (buccal), molarblock, spider screw k1 short neck
Sponsor Region Gävleborg
Collaborator Malmö University
Start date November 2009
End date September 2016
Trial size 80 participants
Trial identifier NCT02644811, CFUG-479851

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 miniscrews have a better anchorage capacity than molarblock,

- that placement of miniscrews does not cause more pain or discomfort than tooth extractions,

- that molarblock provides increase of anchorage

- that miniscrews are more cost-efficient than conventional anchorage techniques,

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(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.
topical anesthesia (buccal and palatal) Anesthesic Jelly (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 (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) Anesthesic Jelly (buccal)
Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva.
local anesthesia (buccal) Injection (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 Temporary anchorage 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.
(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.
topical anesthesia (buccal and palatal) Anesthesic Jelly (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 (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.

Primary Outcomes

Measure
Change in Tooth Position of the Maxillary Molars During Space Closure
time frame: Through Space Closure (T2-T3), an average of 9 months

Secondary Outcomes

Measure
Experience of Pain and Discomfort
time frame: 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
time frame: Through Levelling and Alignment (T1-T2), an average of 9 months
Societal Costs
time frame: Through Study Completion, an average of 2 years

Eligibility Criteria

Male or female participants from 11 years up to 20 years old.

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 - Regular dental care since the age of three. Exclusion Criteria: - Experience of previous orthodontic treatment - Need for orthognathic surgery.

Additional Information

Official title Miniscrews as Anchorage Device for Orthodontic Treatment - Randomized Controlled Trials on Anchorage Capacity, Cost Efficiency and Patient Acceptance
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
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Region Gävleborg.