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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04063696
Other study ID # DT17/103574
Secondary ID 23185818-WS-0111
Status Recruiting
Phase
First received
Last updated
Start date August 24, 2018
Est. completion date December 31, 2023

Study information

Verified date May 2021
Source University of Leeds
Contact Sue Pavitt, PhD
Phone 0113 34 34411
Email s.pavitt@leeds.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 31, 2023
Est. primary completion date August 23, 2023
Accepts healthy volunteers No
Gender All
Age group 5 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Leeds Dental Institute Leeds West Yorkshire

Sponsors (2)

Lead Sponsor Collaborator
University of Leeds Oral and Dental Research Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 2 hours before tooth extraction procedure
Primary Main endpoint: Antimicrobial survey Antimicrobial survey Up to 2 hours before tooth extraction procedure
Primary 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. Up to 2 hours before tooth extraction procedure
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