Dental AnxietyACCOLaDENCT04063696
AntibaCterial presCribing & OraL Health Practice
An observational study of Dental Anxiety and Tooth Loss, run by University of Leeds at 1 site in United Kingdom.
Trial summary
A study by Allied Health Professionals to explore the experience of patients undergoing tooth extraction at Leeds Dental Institute in relation to antibiotic medication, dental anxiety and oral health practices Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Dental Anxiety, Tooth Loss
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Aug 2018to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients attending Leeds Dental Institute for tooth extraction.
Who may be able to join
- Adult patients undergoing extraction of one or more teet
- Parents/Guardians of children aged 5-12 years old undergoing extraction of one or more teeth
- Patients aged 13-15 undergoing extraction of one or more teeth
- Patients and Parents/Guardians who are willing to give informed consent or assent to complete questionnaires
Who cannot join
- Patients, parents/guardians unable or unwilling to provide informed consent
- Parents/Guardians of patients aged less than 5 years old
- Patients or parents who are unable to communicate directly with the health person carrying out the treatment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Dental Institute
Leeds, West Yorkshire, LS2 9LU
Nuria Navarro Coy, 0113 34 34411, n.navarro-coy@leeds.ac.uk
DenTCRU Operations & Strategic Manager, 0113 34 34411, dentcru@leeds.ac.uk
About this study
Official title: AntibaCterial presCribing & OraL Health Practice: The Leeds Dental Extraction Study
A study by Allied Health Professionals to explore the experience of patients undergoing tooth extraction at Leeds Dental Institute in relation to antibiotic medication, dental anxiety and oral health practices
Read the detailed description
Consented patients attending the Leeds Dental Institute for tooth extraction will be asked to complete 3 questionnaires in order for the researchers to understand more about the background of patients who have teeth extracted at the centre. The study will focus on the patient's previous experience of dentistry such as whether they have had antibiotics prescribed for toothache, whether they suffer from dental anxiety and how they regularly look after their oral health.
- Conditions
- Dental Anxiety, Tooth Loss
- Keywords
- tooth extraction, dental anxiety, antibiotic, oral health
- Medical subject headings
- Tooth Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
Main endpoint: WHO Oral Health Questionnaire for Adults (Annexe 7) or WHO Oral Health Questionnaire for Children (Annexe 8)
The use of these two simplified structured questionnaires is recommended by WHO for the collection of self-assessed data on oral health and risk factors in adults (Annex 7) and in children or adolescents (Annex 8). The simplified questionnaires include the core questions considered essential in national oral health surveillance. Complete analysis of answers to the questions on oral health related quality of life, consumption of sugary foods and drinks, consumption of tobacco, and harmful use of alcohol will require derivate variables. There are corresponding questions in the questionnaire to children. Behavioural indices may be generated from these questions by addition of the item scores chosen by the respondent. Cut-off points for categories (3 or 5) may then be determined from empirical distributions.
Measured: Up to 2 hours before tooth extraction procedure
Main endpoint: Antimicrobial survey
Antimicrobial survey
Measured: Up to 2 hours before tooth extraction procedure
Main endpoint: Modified Child Dental Anxiety Scale (MCDAS) v1.0 dated 17/10/2016 (Wong et al 1998)
Modified Child Dental Anxiety Scale (MCDAS) v1.0 dated 17/10/2016 (Wong et al 1998). An 8-question Modified Child Dental Anxiety Scale to assess children's concerns about specific dental procedures, such as dental examination, scale and polish, injection, filling, extraction, and relative and general anaesthesia.
Measured: Up to 2 hours before tooth extraction procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start24 Aug 2018
- Primary completion23 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Oral and Dental Research Trust
- Responsible party
- Principal investigator, Sue Pavitt, University of Leeds
- Investigators
- Sue Pavitt, PhD, Study director, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063696
- Sponsor's protocol ID
- DT17/103574
- Other IDs
- 231858, 18-WS-0111
- Acronym
- ACCOLaDE
- Status last verified
- May 2021
- First submitted
- 8 Nov 2018
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AntibaCterial presCribing & OraL Health Practice: The Leeds Dental Extraction Study
- ClinicalTrials.gov ID
- NCT04063696
- Acronym / sponsor ID
- ACCOLaDE / DT17/103574
- Conditions
- Dental Anxiety, Tooth Loss
- Keywords
- tooth extraction, dental anxiety, antibiotic, oral health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Oral and Dental Research Trust
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 23 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study by Allied Health Professionals to explore the experience of patients undergoing tooth extraction at Leeds Dental Institute in relation to antibiotic medication, dental anxiety and oral health practices
Detailed description
Consented patients attending the Leeds Dental Institute for tooth extraction will be asked to complete 3 questionnaires in order for the researchers to understand more about the background of patients who have teeth extracted at the centre. The study will focus on the patient's previous experience of dentistry such as whether they have had antibiotics prescribed for toothache, whether they suffer from dental anxiety and how they regularly look after their oral health.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients attending Leeds Dental Institute for tooth extraction.
Key inclusion criteria (4 listed)
- Adult patients undergoing extraction of one or more teet
- Parents/Guardians of children aged 5-12 years old undergoing extraction of one or more teeth
- Patients aged 13-15 undergoing extraction of one or more teeth
- Patients and Parents/Guardians who are willing to give informed consent or assent to complete questionnaires
Key exclusion criteria (3 listed)
- Patients, parents/guardians unable or unwilling to provide informed consent
- Parents/Guardians of patients aged less than 5 years old
- Patients or parents who are unable to communicate directly with the health person carrying out the treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Main endpoint: WHO Oral Health Questionnaire for Adults (Annexe 7) or WHO Oral Health Questionnaire for Children (Annexe 8)
Time frame: Up to 2 hours before tooth extraction procedure
The use of these two simplified structured questionnaires is recommended by WHO for the collection of self-assessed data on oral health and risk factors in adults (Annex 7) and in children or adolescents (Annex 8). The simplified questionnaires include the core questions considered essential in national oral health surveillance. Complete analysis of answers to the questions on oral health related quality of life, consumption of sugary foods and drinks, consumption of tobacco, and harmful use of alcohol will require derivate variables. There are corresponding questions in the questionnaire to children. Behavioural indices may be generated from these questions by addition of the item scores chosen by the respondent. Cut-off points for categories (3 or 5) may then be determined from empirical distributions.
Main endpoint: Antimicrobial survey
Time frame: Up to 2 hours before tooth extraction procedure
Antimicrobial survey
Main endpoint: Modified Child Dental Anxiety Scale (MCDAS) v1.0 dated 17/10/2016 (Wong et al 1998)
Time frame: Up to 2 hours before tooth extraction procedure
Modified Child Dental Anxiety Scale (MCDAS) v1.0 dated 17/10/2016 (Wong et al 1998). An 8-question Modified Child Dental Anxiety Scale to assess children's concerns about specific dental procedures, such as dental examination, scale and polish, injection, filling, extraction, and relative and general anaesthesia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Individual participant dataSharing planned: No
Related trials for Dental Anxiety
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Recruiting
Pain Perception With Cordless Electronic Local Anesthetic Delivery System
Decayed Primary Molars
RecruitingObservational study
Bruxism, Anxiety, and Periodontal Status Among Dental Students
Bruxism, Anxiety
Recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
Active, not recruiting
Musical Intervention for Dental Anxiety
Dental Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sue Pavitt, PhD study director
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Anxiety and Tooth Loss, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sue Pavitt, PhD (0113 34 34411, s.pavitt@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main endpoint: WHO Oral Health Questionnaire for Adults (Annexe 7) or WHO Oral Health Questionnaire for Children (Annexe 8) (time frame: Up to 2 hours before tooth extraction procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.