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N/A N=78 Randomized Single-blind Treatment

Chesterfield Micro-implant Study Involving Three Types of Anchorage Methods in Orthodontics

Malocclusion · Class II Buccal Segment Relationship

Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Anchorage Loss Measured From 3-D Model Scanning — 0.80; 1.84; 1.36; 0.99 mm — p=0.05

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Extraoral anchorage (Device); Miniscrews (Device); Nance (Device)
Age
Pediatric · 12+ yrs
Sex
All
Sponsor
Chesterfield and North Derbyshire Royal Hospital
Primary completion
Oct 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Anchorage Loss Measured From 3-D Model Scanning
0.80; 1.84; 1.36; 0.99; 2.09; 1.99 0.05
SECONDARY
Patient Perception of the Different Treatment Methods, Including Surgical Experience

Summary

Research problem: Anchorage reinforcement is effective with headgear provided patient compliance is optimal. Nance palatal arch have also been shown to be effective. Microscrews despite their popularity however have no scientific evidence to support their use. Aim: To compare the effectiveness of 3 methods of anchorage reinforcement 1) headgear 2) Nance palatal arch 3) orthodontic micro-screws. Hypothesis: There is no difference in the amount of anchorage loss between the three methods of anchorage reinforcement. Design: Randomized clinical trial. Setting: District General Hospital orthodontic department Participants: 78 patients requiring "absolute anchorage". Interventions: The subjects will be randomized into 3 groups. In group 1 headgear will be requested 12-14 hours per day. In group 2 a nance palatal arch will be placed for use as intra oral anchorage reinforcement. In group 3, orthodontic micro-screws will be used for anchorage. Method of investigation: The study will be of 78 'absolute anchorage' patients older than 12 years randomly assigned to one of three groups of anchorage reinforcement Outcome measures: 1. Anchorage loss measured from lateral Cephalometric radiographs and 3-D model scanning, records will be taken at three points 2. Patient perception of the different treatment methods, including surgical experience Data analysis: The data will be analysed on an intention to treat basis. Basic descriptive statistics and uni-variate tests will initially be done to explore the data. Final data analysis will involve the relevant multi-variate statistical modeling. Dissemination: Conference proceedings, journal papers and the Cochrane oral health group.

Eligibility Criteria

Inclusion Criteria

  • Seventy-five children maximum anchorage cases, aged aged 12-17 referred from the General Dental Service to Chesterfield Royal Hospital will be selected to take part in this study.
  • Informed consent will be obtained.

Exclusion Criteria

  • Previous orthodontic treatment,
  • Unwillingness to accept any of the three methods of treatment, OR
  • Syndromes or clefts.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00995436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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