Condition category
Oral Health
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
02/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Philip Benson

ORCID ID

Contact details

University of Sheffield
Child Dental Health
Charles Clifford Dental Hospital
Sheffield
S10 2SZ
United Kingdom
+44 (0)114 271 7895 / 7885
p.benson@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0059108300

Study information

Scientific title

Acronym

Study hypothesis

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

Added July 2008: Ethical approval for this study was obtained from North Derbyshire
Health and South Sheffield Local Research Ethics committees.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Oral Health: Orthodontics

Intervention

The anchorage offered by implants will be compared with that from conventional orthodontic anchorage reinforcement techniques.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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)

Secondary outcome measures

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

Overall trial start date

01/01/2002

Overall trial end date

01/06/2005

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 patients

Participant 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.

Recruitment start date

01/01/2002

Recruitment end date

01/06/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Sheffield
Sheffield
S10 2SZ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Sheffield Teaching Hospitals (Central Campus) - UK

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 results on main outcome in http://www.ncbi.nlm.nih.gov/pubmed/18005834
2. 2008 results on other outcomes in http://www.ncbi.nlm.nih.gov/pubmed/18174071

Publication citations

  1. Results on main outcome

    Benson PE, Tinsley D, O'Dwyer JJ, Majumdar A, Doyle P, Sandler PJ, Midpalatal implants vs headgear for orthodontic anchorage--a randomized clinical trial: cephalometric results., Am J Orthod Dentofacial Orthop, 2007, 132, 5, 606-615, doi: 10.1016/j.ajodo.2006.01.040.

  2. Results on other outcomes

    Sandler J, Benson PE, Doyle P, Majumder A, O'Dwyer J, Speight P, Thiruvenkatachari B, Tinsley D, Palatal implants are a good alternative to headgear: a randomized trial., Am J Orthod Dentofacial Orthop, 2008, 133, 1, 51-57, doi: 10.1016/j.ajodo.2007.04.032.

Additional files

Editorial Notes