Trial Outcomes & Findings for Chesterfield Micro-implant Study Involving Three Types of Anchorage Methods in Orthodontics (NCT NCT00995436)

NCT ID: NCT00995436

Last Updated: 2016-08-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 78 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2016-08-05

Participant Flow

This trial was conducted between August 2008 and February 2013 in two orthodontic departments in the United Kingdom.

90 patients assesses as eligible. 12 chose not to take part

Participant milestones

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

Reasons for withdrawal

Measure	Headgear Placement of extraoral traction to be worn 100 hours per week Extraoral anchorage : Extra oral anchorage using headgear	Miniscrews Placement of micro-screw to supplement anchorage Intraoral skeletal anchorage - Temporary anchorage device : Intraoral skeletal anchorage using mini screws	Nance Palatal Arch Anchorage supplemented by fixing molars together with an arch Intraoral dental anchorage : Intraoral dental anchorage by using Nance palatal arch on molars
Overall Study Withdrawal by Subject	2	5	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Headgear n=25 Participants Placement of extraoral traction to be worn 100 hours per week Extraoral anchorage : Extra oral anchorage using headgear	Miniscrews n=27 Participants Placement of micro-screw to supplement anchorage Intraoral skeletal anchorage - Temporary anchorage device : Intraoral skeletal anchorage using mini screws	Nance Palatal Arch n=26 Participants Anchorage supplemented by fixing molars together with an arch Intraoral dental anchorage : Intraoral dental anchorage by using Nance palatal arch on molars	Total n=78 Participants Total of all reporting groups
Age, Continuous	14.38 years STANDARD_DEVIATION 1.67 • n=5 Participants	14.15 years STANDARD_DEVIATION 1.25 • n=7 Participants	14.14 years STANDARD_DEVIATION 1.48 • n=5 Participants	14.22 years STANDARD_DEVIATION 1.46 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants	39 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	17 Participants n=7 Participants	7 Participants n=5 Participants	39 Participants n=4 Participants
Region of Enrollment United Kingdom	25 participants n=5 Participants	27 participants n=7 Participants	26 participants n=5 Participants	78 participants n=4 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Measure	Miniscrews n=22 Participants Device Placement of micro-screw to supplement anchorage Intraoral skeletal anchorage - Temporary anchorage device: Intraoral skeletal anchorage using mini screws	Nance Palatal Arch n=26 Participants Anchorage supplemented by fixing molars together with an arch Intraoral dental anchorage: Intraoral dental anchorage by using Nance palatal arch on molars	Headgear n=23 Participants
Anchorage Loss Measured From 3-D Model Scanning Maxillary right molar	0.80 mm Standard Deviation 1.6	1.84 mm Standard Deviation 1.32	1.36 mm Standard Deviation 1.83
Anchorage Loss Measured From 3-D Model Scanning Maxillary left molar	0.99 mm Standard Deviation 1.15	2.09 mm Standard Deviation 1.32	1.99 mm Standard Deviation 2.09

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

Adverse Events

Headgear

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Miniscrews

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nance Palatal Arch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jonathan Sandler

ChestyerfieldNDRH

Phone: 01246512106

Email: JonSandler57@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place