Palatal implants versus headgear for orthodontic anchorage - a randomised controlled trial

ISRCTN	ISRCTN24433142
DOI	https://doi.org/10.1186/ISRCTN24433142
Protocol serial number	N0059108300
Sponsor	Department of Health (UK)
Funder	Sheffield Teaching Hospitals (Central Campus) - UK

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 02/07/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Philip Benson
Scientific

University of Sheffield
Child Dental Health
Charles Clifford Dental Hospital
Sheffield
S10 2SZ
United Kingdom

Phone	+44 (0)114 271 7895 / 7885
Email	p.benson@sheffield.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	To evaluate the clinical effectiveness of the mid-sagittal implant as a method of preventing unwanted tooth movement (anchorage) during orthodontic treatment. The anchorage offered by implants will be compared with that from conventional orthodontic anchorage reinforcement techniques.
Ethics approval(s)	Added July 2008: Ethical approval for this study was obtained from North Derbyshire Health and South Sheffield Local Research Ethics committees.
Health condition(s) or problem(s) studied	Oral Health: Orthodontics
Intervention	The anchorage offered by implants will be compared with that from conventional orthodontic anchorage reinforcement techniques.
Intervention type	Other
Primary outcome measure(s)	Tooth movement. The difference in the mesial drift of the buccal teeth to be calculated: a. Relative to the cranial base using the Pitchfork analysis (Luecke and Johnston, 1992; Johnston, 1996) on the start and finish lateral cephalometric radiograph b. Relative to the palatal rugae, from the start and finish study models (Hoggan and Sadowsky, 2001)
Key secondary outcome measure(s)	1. Implant stability, discomfort and any signs of inflammation of the peri-implant tissues will be recorded with percussion tests using a Resonance Frequency Analyser (Meredith, 1998) and standard periodontal indices 2. Patient acceptability, compliance and discomfort measured using a questionnaire 3. Treatment outcome measured with the Peer Assessment Rating (PAR) index on the pre- and post-treatment study models
Completion date	01/06/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	40
Key inclusion criteria	Added July 2008: The patients in the study all needed absolute anchorage, and no forward movement of upper molars could be allowed for successful treatment.
Key exclusion criteria	Added July 2008: Poor oral hygiene, unwilling to wear fixed appliances, unwilling to wear headgear or have the implant placed, and medical history precluding fixed appliance treatment.
Date of first enrolment	01/01/2002
Date of final enrolment	01/06/2005

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Sheffield

Sheffield
S10 2SZ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results on main outcome	01/11/2007		Yes	No
Results article	results on other outcomes	01/01/2008		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes