AntibaCterial presCribing & OraL Health Practice

• Conditions: Tooth Loss; Dental Anxiety

• Registration Number: NCT04063696
• Lead Sponsor: University of Leeds

Brief 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

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 Timeline

• Study Start: 2018-08-24
• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2019-08-20
• Study First Posted: 2019-08-21
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-24
• Last Update Posted: 2021-05-27
• Primary Completion: 2023-08-23
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main endpoint: Modified Child Dental Anxiety Scale (MCDAS) v1.0 dated 17/10/2016 (Wong et al 1998)	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.
Main endpoint: Antimicrobial survey	Up to 2 hours before tooth extraction procedure	Antimicrobial survey
Main endpoint: WHO Oral Health Questionnaire for Adults (Annexe 7) or WHO Oral Health Questionnaire for Children (Annexe 8)	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.

Trial Locations

Locations (1)

Leeds Dental Institute; 🇬🇧 Leeds, West Yorkshire, United Kingdom