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Completed

NCT Number: NCT02644811

Miniscrews as Anchorage Device for Orthodontic Treatment

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

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Key information

Conditions

Orthodontic Anchorage Procedures Orthodontic Space Closure

Age range

11 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Specialisttandvården Ortodonti

Gävle, Gävleborg County, 80102, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Anesthesic Jelly (buccal and palatal)

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).

Other names: Injection (buccal and palatal)

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.

Other names: Anesthesic Jelly (buccal)

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).

Other names: Injection (buccal)

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.

Other names: Temporary anchorage device, TAD, Orthodontic mini-implant

Primary outcomes

  1. Change in Tooth Position of the Maxillary Molars During Space Closure

    Time frame: 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 outcomes

  1. 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

    Experiences of pain and discomfort are examined with validated self-report questionnaires.

  2. 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

    Tooth movement is assessed in millimeters using superimposition of study models and lateral cephalograms.

  3. Societal Costs

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Region Gävleborg

Other

Collaborators

  • Malmö University
  • Swedish Dental Associations Scientific Funds
  • Uppsala University

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Jan 1, 2016
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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