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

• Sponsor: Chesterfield and North Derbyshire Royal Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00995436
• Collaborator: (none)
• Enrollment: 78
• Location: 1
• Arms: 3
• Duration (Months): 63
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Malocclusion; Class II Buccal Segment Relationship	Device: Extraoral anchorage; Device: Miniscrews; Device: Nance	N/A

Detailed Description

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

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.

I took professional statistical advice from a senior statistician at the University of Manchester. Analysis of covariance was used and Headgear (as our default treatment) was used as the reference category. Results with Nance and TADs are relative to the reference category of headgear.

Study Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Efficiency and Effectiveness of Three Methods of Anchorage Reinforcement in Orthodontics
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Extraoral anchorage The intervention is the placement of Headgear, to be worn 100 hours per week	Device: Extraoral anchorage; Extra oral anchorage
Active Comparator: Miniscrews The intervention is the of miniscrews to supplement anchorage	Device: Miniscrews; Intraoral skeletal anchorage using mini screws; Other Names: miniscrew for anchorage reinforcement
Active Comparator: Nance palatal arch Anchorage supplemented by Nance palatal arch fixing molars together with an arch	Device: Nance; Intraoral dental anchorage by using Nance palatal arch on molars; Other Names: Nance button

Outcome Measures

Primary Outcome Measures

1. Anchorage Loss Measured From 3-D Model Scanning [2 years]

Secondary Outcome Measures

1. Patient Perception of the Different Treatment Methods, Including Surgical Experience [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chesterfield Royal Hospital	Chesterfield	Derbyshire	United Kingdom	S445BL

Sponsors and Collaborators

• Chesterfield and North Derbyshire Royal Hospital

Investigators

• Study Chair: Jonathan Sandler, BDSMSc MOrth, Chesterfield North Derbyshire NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jonathan Sandler, Principal Investigator, Chesterfield and North Derbyshire Royal Hospital
• ClinicalTrials.gov Identifier: NCT00995436
• Other Study ID Numbers: 07/Q2401/50; REC 07/Q2401/50; BOSF 2006 Grant 1
• First Posted: Oct 15, 2009
• Last Update Posted: Aug 5, 2016
• Last Verified: Aug 1, 2016

• Keywords provided by Jonathan Sandler, Principal Investigator, Chesterfield and North Derbyshire Royal Hospital: Extractions; Anchorage supplementation
• Additional relevant MeSH terms: Malocclusion

Study Results

Participant Flow

Recruitment Details	This trial was conducted between August 2008 and February 2013 in two orthodontic departments in the United Kingdom.
Pre-assignment Detail	90 patients assesses as eligible. 12 chose not to take part

Arm/Group Title	Headgear	Miniscrews	Nance Palatal Arch
Arm/Group Description	Placement of extraoral traction to be worn 100 hours per week Extraoral anchorage : Extra oral anchorage using headgear	Placement of micro-screw to supplement anchorage Intraoral skeletal anchorage - Temporary anchorage device : Intraoral skeletal anchorage using mini screws	Anchorage supplemented by fixing molars together with an arch Intraoral dental anchorage : Intraoral dental anchorage by using Nance palatal arch on molars
Period Title: Overall Study
STARTED	25	27	26
COMPLETED	23	22	26
NOT COMPLETED	2	5	0

Baseline Characteristics

Arm/Group Title	Headgear	Miniscrews	Nance Palatal Arch	Total
Arm/Group Description	Placement of extraoral traction to be worn 100 hours per week Extraoral anchorage : Extra oral anchorage using headgear	Placement of micro-screw to supplement anchorage Intraoral skeletal anchorage - Temporary anchorage device : Intraoral skeletal anchorage using mini screws	Anchorage supplemented by fixing molars together with an arch Intraoral dental anchorage : Intraoral dental anchorage by using Nance palatal arch on molars	Total of all reporting groups
Overall Participants	25	27	26	78
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.38 (1.67)	14.15 (1.25)	14.14 (1.48)	14.22 (1.46)
Sex: Female, Male (Count of Participants)
Female	10 40%	10 37%	19 73.1%	39 50%
Male	15 60%	17 63%	7 26.9%	39 50%
Region of Enrollment (participants) [Number]
United Kingdom	25 100%	27 100%	26 100%	78 100%

Outcome Measures

1. Primary Outcome

Title	Anchorage Loss Measured From 3-D Model Scanning
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Miniscrews	Nance Palatal Arch	Headgear
Arm/Group Description	Device Placement of micro-screw to supplement anchorage Intraoral skeletal anchorage - Temporary anchorage device: Intraoral skeletal anchorage using mini screws	Anchorage supplemented by fixing molars together with an arch Intraoral dental anchorage: Intraoral dental anchorage by using Nance palatal arch on molars
Measure Participants	22	26	23
Maxillary right molar	0.80 (1.6)	1.84 (1.32)	1.36 (1.83)
Maxillary left molar	0.99 (1.15)	2.09 (1.32)	1.99 (2.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Miniscrews, Headgear
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.58
	Confidence Interval	(2-Sided) 95%; -1.53 to 0.36
	Parameter Dispersion	Type: Value:
	Estimation Comments	Maxillary right molar

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Miniscrews, Headgear
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.96
	Confidence Interval	(2-Sided) 95%; -1.89 to -0.04
	Parameter Dispersion	Type: Value:
	Estimation Comments	Maxillary left molar

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Nance Palatal Arch, Headgear
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.62
	Confidence Interval	(2-Sided) 95%; -0.32 to 1.55
	Parameter Dispersion	Type: Value:
	Estimation Comments	Maxillary right molar

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Nance Palatal Arch, Headgear
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.09
	Confidence Interval	(2-Sided) 95%; -1 to 0.83
	Parameter Dispersion	Type: Value:
	Estimation Comments	Maxillary left molar

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Miniscrews, Nance Palatal Arch, Headgear
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.
Statistical Test of Hypothesis	p-Value	0.05
	Comments	Maxillary right molar. F(2, 67) = 3.10. Overall effect of treatment.
	Method	ANCOVA
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Miniscrews, Nance Palatal Arch, Headgear
	Comments	Maxillary left molar.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.
Statistical Test of Hypothesis	p-Value	0.08
	Comments	Overall effect of treatment F(2,67) = 2.58.
	Method	ANCOVA
	Comments

2. Secondary Outcome

Title	Patient Perception of the Different Treatment Methods, Including Surgical Experience
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Headgear		Miniscrews		Nance Palatal Arch
Arm/Group Description	Device Placement of extraoral traction to be worn 100 hours per week Extraoral anchorage: Extra oral anchorage		Device Placement of micro-screw to supplement anchorage Intraoral skeletal anchorage - Temporary anchorage device: Intraoral skeletal anchorage using mini screws		Anchorage supplemented by fixing molars together with an arch Intraoral dental anchorage: Intraoral dental anchorage by using Nance palatal arch on molars
All Cause Mortality
	Headgear		Miniscrews		Nance Palatal Arch
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Headgear		Miniscrews		Nance Palatal Arch
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Headgear		Miniscrews		Nance Palatal Arch
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)		0/26 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.