AntibaCterial presCribing & OraL Health Practice

Dental Anxiety Clinical Trial

— ACCOLaDE  

Official title:

AntibaCterial presCribing & OraL Health Practice: The Leeds Dental Extraction Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04063696
• Other study ID #: DT17/103574
• Secondary ID: 23185818-WS-0111
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Dental Anxiety
• Tooth Loss

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