Miniscrews as Anchorage Device for Orthodontic Treatment

NCT02644811 | Completed

• 1 other identifier: CFUG-479851
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Orthodontic Anchorage Procedures; Orthodontic Space Closure

Keywords

Miniscrew; Temporary anchorage device (TAD); mini-implants; Miniscrew implant (MSI)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Change in Tooth Position of the Maxillary Molars During Levelling and Alignment

  Through Levelling and Alignment (T1-T2), an average of 9 months

• Societal Costs

  Through Study Completion, an average of 2 years

Study Arms (2)

Group A - Miniscrews

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.

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: Spider Screw K1 short neck

Group B - Molarblock

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.

Drug: Topical anesthesia (buccal and palatal); Drug: Local anesthesia (buccal and palatal); Procedure: Extraction of the maxillary first premolars; Device: Molarblock

Interventions

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.

Also known as: Anesthesic Jelly (buccal and palatal)

Group A - Miniscrews; Group B - Molarblock

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).

Also known as: Injection (buccal and palatal)

Group A - Miniscrews; Group B - Molarblock

Extraction of the maxillary first premolars PROCEDURE

Careful extraction of the maxillary first premolars after mobilization.

Group A - Miniscrews; Group B - Molarblock

Topical anesthesia (buccal) DRUG

Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva.

Also known as: Anesthesic Jelly (buccal)

Group A - Miniscrews

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).

Also known as: Injection (buccal)

Group A - Miniscrews

Molarblock DEVICE

Molarblock is a Stainless steel ligature connecting the maxillary second premolar with the maxillary first and second molar.

Group B - Molarblock

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.

Also known as: Temporary anchorage device, TAD, Orthodontic mini-implant

Group A - Miniscrews

Eligibility Criteria

• Age: 11 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Experience of previous orthodontic treatment
• Need for orthognathic surgery
• Need for maximum anchorage.

Sponsors & Collaborators

• Region Gävleborg: lead
• Malmö University: collaborator
• Department of Research and Development, County Council of Gavleborg and Uppsala University: collaborator
• Swedish Dental Associations Scientific Funds: collaborator
• Thuréus Foundation for the Promotion of Dental Science, Uppsala University, Sweden: collaborator

Study Sites (1)

Specialisttandvården Ortodonti

Gävle, Gävleborg County, 80102, Sweden

Location

Related Publications (11)

• Feldmann I, List T, John MT, Bondemark L. Reliability of a questionnaire assessing experiences of adolescents in orthodontic treatment. Angle Orthod. 2007 Mar;77(2):311-7. doi: 10.2319/0003-3219(2007)077[0311:ROAQAE]2.0.CO;2.

  PMID: 17319767 BACKGROUND

• Upadhyay M, Yadav S, Nanda R. Biomechanics of incisor retraction with mini-implant anchorage. J Orthod. 2014 Sep;41 Suppl 1:S15-23. doi: 10.1179/1465313314Y.0000000114.

  PMID: 25138361 BACKGROUND

• Upadhyay M, Yadav S, Patil S. Mini-implant anchorage for en-masse retraction of maxillary anterior teeth: a clinical cephalometric study. Am J Orthod Dentofacial Orthop. 2008 Dec;134(6):803-10. doi: 10.1016/j.ajodo.2006.10.025.

  PMID: 19061808 BACKGROUND

• Lehnen S, McDonald F, Bourauel C, Baxmann M. Patient expectations, acceptance and preferences in treatment with orthodontic mini-implants. A randomly controlled study. Part I: insertion techniques. J Orofac Orthop. 2011 Mar;72(2):93-102. doi: 10.1007/s00056-011-0013-8. English, German.

  PMID: 21503849 BACKGROUND

• Feldmann I, List T, Feldmann H, Bondemark L. Pain intensity and discomfort following surgical placement of orthodontic anchoring units and premolar extraction: a randomized controlled trial. Angle Orthod. 2007 Jul;77(4):578-85. doi: 10.2319/062506-257.1.

  PMID: 17605489 BACKGROUND

• Feldmann I, List T, Bondemark L. Orthodontic anchoring techniques and its influence on pain, discomfort, and jaw function--a randomized controlled trial. Eur J Orthod. 2012 Feb;34(1):102-8. doi: 10.1093/ejo/cjq171. Epub 2011 Feb 7.

  PMID: 21300723 BACKGROUND

• Melsen B, Costa A. Immediate loading of implants used for orthodontic anchorage. Clin Orthod Res. 2000 Feb;3(1):23-8. doi: 10.1034/j.1600-0544.2000.030105.x.

  PMID: 11168281 BACKGROUND

• Lai EH, Yao CC, Chang JZ, Chen I, Chen YJ. Three-dimensional dental model analysis of treatment outcomes for protrusive maxillary dentition: comparison of headgear, miniscrew, and miniplate skeletal anchorage. Am J Orthod Dentofacial Orthop. 2008 Nov;134(5):636-45. doi: 10.1016/j.ajodo.2007.05.017.

  PMID: 18984395 BACKGROUND

• Papadopoulos MA, Tarawneh F. The use of miniscrew implants for temporary skeletal anchorage in orthodontics: a comprehensive review. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 May;103(5):e6-15. doi: 10.1016/j.tripleo.2006.11.022. Epub 2007 Feb 21.

  PMID: 17317235 BACKGROUND

• Ganzer N, Feldmann I, Petren S, Bondemark L. A cost-effectiveness analysis of anchorage reinforcement with miniscrews and molar blocks in adolescents: a randomized controlled trial. Eur J Orthod. 2019 Mar 29;41(2):180-187. doi: 10.1093/ejo/cjy041.

  PMID: 30668660 DERIVED

• Ganzer N, Feldmann I, Bondemark L. Anchorage reinforcement with miniscrews and molar blocks in adolescents: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2018 Dec;154(6):758-767. doi: 10.1016/j.ajodo.2018.07.011.

  PMID: 30477773 DERIVED

MeSH Terms

Interventions

Anesthesia; Anesthesia, Local; Injections

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Anesthesia, Conduction; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Lars Bondemark, Professor

  Malmö University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, Senior Consultant Orthodontist

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: January 1, 2016
• Study Start: November 1, 2009
• Primary Completion: July 1, 2018
• Study Completion: September 21, 2018
• Last Updated: February 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)