Condition category
Oral Health
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
09/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Upper (maxillary) canines erupt at approximately 11-12 years of age. Occasionally, these teeth erupt into the wrong position or do not erupt at all and become ‘impacted’. The upper canine can become displaced towards the cheek (buccally) or into the roof of the mouth (palatally). Approximately 1-2% of the population is affected. Upper canines become impacted palatally in 85% of cases and buccally in 15%.
Management of established canine impactions often requires surgical and orthodontic intervention if the canine is to be correctly positioned within the dental arch.
This study compares the use of a coverplate (CP) versus a sutured periodontal dressing (PD) following surgical exposure of palatal canine teeth.

Who can participate?
Patients taken consecutively from the orthodontic waiting list at Queen Alexandra Hospital fulfilling the following criteria:
1. Age 12 – 20
2. Requiring exposure of a palatally impacted canine(s)
3. Requiring general anaesthesia for exposure

What does the study involve?
Patients will be randomly allocated to one of two treatments: placement of a coverplate after exposure of a palatally impacted canine which is removed approximately 1 week after exposure; or suturing a periodontal dressing over the exposed canine which is removed approximately 1 week following exposure.

Patients will be seen again 7-10 days after the exposure of the tooth, when the cover-plate or the dressing will be removed. Instructions will be given on how to keep the area clean.

What are the possible benefits and risks of participating?
The results of this study may help us treat future patients in a more efficient manner.
One possible disadvantage is that the treatment involving a cover-plate requires one extra visit 1 week before surgery to be able to make the cover-plate.

Where is the study run from?
The study was carried out in the Orthodontic Department, Queen Alexandra Hospital, Portsmouth (UK).

When is the study starting and how long is it expected to run for?
The study took place between October 2005 and October 2007.

Who is funding the study?
Portsmouth NHS Research and Development Consortium (UK)

Who is the main contact?
Dr Sirisha Ponduri
sirishaponduri@hotmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sirisha Ponduri

ORCID ID

Contact details

Maxillofacial Department
Cosham
Portsmouth
P06 3LY
United Kingdom
+44 07815 130576
sirishaponduri@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0187173586

Study information

Scientific title

Exposure of palatal canines: cover-plate vs periodontal dressing - A randomised clinical trial

Acronym

Study hypothesis

The aims and objectives of this project is to compare the use of a cover-plate with the use of a sutured periodontal dressing following surgical exposure of the palatally impacted canine to see if one form of treatment is better than the other.

Ethics approval

Isle of Wight, Portsmouth & SE Hampshire REC

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Palatally impacted canine(s)

Intervention

1. Placement of a coverplate after exposure of a palatally impacted canine which is removed approximately 1 week after exposure
2. Suturing a periodontal dressing over the exposed canine which is removed approximately 1 week following exposure

The patient will be randomised to one of the two treatments (detailed above). Patients in each group then have a different treatment and these are compared.

So each participant will either have a cover-plate following surgery or the dressing. They will be seen again 7-10 days after the exposure of the tooth, when the cover-plate or the dressing will be removed. Instructions will be given on how to keep the area clean.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Exposure successful (re-exposure required?)
2. Was the coverplate/periodontal dressing in situ until the review appointment.
3. Patient comfort (visual analogue scale)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

11/10/2005

Overall trial end date

01/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 12 – 20
2. Requiring exposure of a palatally impacted canine(s)
3. Requiring general anaesthesia for exposure

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

100 participants (50 in each group).

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

11/10/2005

Recruitment end date

01/10/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Maxillofacial Department
Portsmouth
P06 3LY
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Portsmouth NHS Research and Development Consortium (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

Publication citations

Additional files

Editorial Notes

09/03/2016: No publications found, verifying study status with principal investigator.