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 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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
2018 results in: https://www.nature.com/articles/sj.bdj.2018.225