N/A
N=78
Chesterfield Micro-implant Study Involving Three Types of Anchorage Methods in Orthodontics
Malocclusion · Class II Buccal Segment Relationship
Bottom Line
View on ClinicalTrials.gov: NCT00995436 ↗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
| Outcome | Result | p-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.
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.