Condition category
Digestive System
Date applied
21/11/2014
Date assigned
01/12/2014
Last edited
30/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Acute apical abscess is a painful condition in which the tip of a tooth's root becomes inflamed, often resulting in swelling and fever. The aim of the study is to find out who much pain is reduced after patients have been seen at an NHS emergency dental clinic for patients with acute apical abscess. This is a clinic in which patients with urgent dental problems are seen at weekends and in the evening. As we only see patients when they are in pain and not for routine care, we don't know how quickly their pain reduces after treatment. Additionally, we want to know if different treatment strategies favoured by different dentists result in faster pain reduction.

Who can participate?
Adult patients who have acute apical abscess as diagnosed by a dentist.

What does the study involve?
Participants will answer a questionnaire in the waiting area prior to their dental appointment and then on the phone the next day and two days later. This should take no more than 5 minutes.

What are the possible benefits and risks of participating?
The benefit of taking part is knowing that you are helping to improve the treatment given to future patients. Patients will receive the same level of care if they participate or not. There is no risk to participating. The only disadvantage to participants is having to give up about 10 minutes of their time.

Where is the study run from?
South West London Urgent Dental Care (UK)

When is the study starting and how long is it expected to run for?
February 2015 to January 2016

Who is funding the study?
South West London Urgent Dental Care (UK)

Who is the main contact?
Scott Aaron
scottaaron99@yahoo.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Scott Aaron

ORCID ID

Contact details

45 Berry Lane
Rickmansworth
WD3 4DE
United Kingdom
+44 (0)192 377 3150
scottaaron@hudc.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRAS 165278

Study information

Scientific title

Efficacy of first aid treatment of acute apical abscess in an NHS emergency clinic in the UK

Acronym

Study hypothesis

Two hypotheses are defined in order to assess the aims of the research:
1. Pain relief by AAA can be obtained in an NHS clinic in the UK
2. Pain relief is greater where drainage method has been established than where it has not

Ethics approval

London - City & East Research Ethics Committee, 12/10/2015, REC ref: 15/LO/0193

Study design

Prospective study involving a pain quality assessment questionnaire

Primary study design

Observational

Secondary study design

Prospective study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Acute apical abscess

Intervention

1. On arrival at the clinic, patients will be asked if they wish to participate in the study. Patients will be advised they are free to consent, or not to join the study, and that a refusal will have no effect on the treatment they receive. They will also receive this in writing, and be informed that they can withdraw their consent to participate at any point. All patients will be offered to participate except when they fulfil one of the exclusion criteria (see below)
2. A DCP will go through the PQAS with the patient in a private room
3. Once the dentist has made a diagnosis, patients who have been diagnosed with AAA will be asked if they wish to participate by phone or email, and patients who have not been diagnosed with AAA will be informed that they won’t be called back.
4. A DCP will call the patient by phone the next day and again 2 days later (i.e., at 72 hours). Patients are seen between 1830 and 2230. Calls to patients will be between 1700 and 2130. DCPs will try to call the patient up to three times if they don’t get through initially. Emails will be accepted for inclusion if they are received between 1400 and 2400. In addition to the PQAS, patients will be asked if they have seen another dentist or doctor since the care provided at this clinic, and if so what was done by this second clinician.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Results will be analysed by a statistician. They will show the level of reduction (or increase) in pain as defined by PQAS. We shall record pulpal diagnosis (necrotic, previous treatment, previously initiated treatment) and which patients have had drainage established, which patients have had drainage established and an antibiotic, and which have had antibiotics only.

Secondary outcome measures

We shall also record drop out rates. Comparison will be made to other studies, often done under more 'ideal' circumstances.

Overall trial start date

01/02/2015

Overall trial end date

31/01/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients of either gender who have acute apical abscess as diagnosed by a dentist

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

34-200

Participant exclusion criteria

1. Children aged under 16
2. Where the reason for attendance (which is sent from the call triage service) is definitely not endodontic in origin
3. Where the patient is unable to speak a reasonable level of English
4. When there is insufficient time prior to the patient’s consultation

Recruitment start date

01/02/2015

Recruitment end date

31/01/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South West London Urgent Dental Care
Edridge Road Community Health Centre 2 Edridge Road
Croydon
CR9 1PJ
United Kingdom

Sponsor information

Organisation

South West London Urgent Dental Care (UK)

Sponsor details

45 Berry Lane
Rickmansworth
WD3 4DE
United Kingdom
+44 (0)192 377 3150
scottaaron@hudc.co.uk

Sponsor type

Other

Website

Funders

Funder type

Hospital/treatment centre

Funder name

South West London Urgent Dental Care (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The aim is to publish in a peer-reviewed journal relevant to endodontics or general dentistry

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/03/2016: Ethics approval information added.