Exposure of palatal canines: cover-plate vs periodontal dressing

ISRCTN	ISRCTN46246539
DOI	https://doi.org/10.1186/ISRCTN46246539
Secondary identifying numbers	N0187173586

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 30/04/2018

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Sirisha Ponduri
Scientific

Maxillofacial Department
Cosham
Portsmouth
P06 3LY
United Kingdom

Phone	+44 07815 130576
Email	sirishaponduri@hotmail.com

Study information

Study design	Single-centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title	Exposure of palatal canines: cover-plate vs periodontal dressing - A randomised clinical trial
Study objectives	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(s)	Isle of Wight, Portsmouth & SE Hampshire REC
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	11/10/2005
Completion date	01/10/2007

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	Both
Target number of participants	100 participants (50 in each group).
Key inclusion criteria	1. Age 12 20 2. Requiring exposure of a palatally impacted canine(s) 3. Requiring general anaesthesia for exposure
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	11/10/2005
Date of final enrolment	01/10/2007

Locations

Countries of recruitment

United Kingdom

Study participating centre

Maxillofacial Department

Portsmouth
P06 3LY
United Kingdom

Sponsor information

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

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Portsmouth NHS Research and Development Consortium (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

30/04/2018: No publications found, verifying study status with principal investigator.
09/03/2016: No publications found, verifying study status with principal investigator.