Miniscrews as Anchorage Device for Orthodontic Treatment

Orthodontic Space Closure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02644811
• Other study ID #: CFUG-479851
• Status: Completed
• Phase: N/A
• Start date: November 2009
• Est. completion date: September 21, 2018

Study information

• Verified date: February 2019
• Source: Region Gävleborg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 21, 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Orthodontic Anchorage Procedures
• Orthodontic Space Closure

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Specialisttandvården Ortodonti	Gävle	Gävleborgs Län

Sponsors (5)

Lead Sponsor	Collaborator
Region Gävleborg	Department of Research and Development, County Council of Gavleborg and Uppsala University, Malmö University, Swedish Dental Associations Scientific Funds, Thuréus Foundation for the Promotion of Dental Science, Uppsala University, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Melsen B, Costa A. Immediate loading of implants used for orthodontic anchorage. Clin Orthod Res. 2000 Feb;3(1):23-8. — View Citation

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. Epub 2007 Feb 21. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Experience of Pain and Discomfort	Experiences of pain and discomfort are examined with validated self-report questionnaires.	Baseline, the evening after tooth extractions, one week after tooth extractions, the evening after miniscrew placement, one week after miniscrew placement
Secondary	Change in Tooth Position of the Maxillary Molars During Levelling and Alignment	Tooth movement is assessed in millimeters using superimposition of study models and lateral cephalograms.	Through Levelling and Alignment (T1-T2), an average of 9 months
Secondary	Societal Costs	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.	Through Study Completion, an average of 2 years