AntibaCterial presCribing & OraL Health Practice (ACCOLaDE)

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

Study Overview

• Status: Recruiting
• Conditions: Dental Anxiety; Tooth Loss

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Sue Pavitt, PhD; Phone Number: 0113 34 34411; Email: s.pavitt@leeds.ac.uk
• Study Contact Backup: Name: DenTCRU Operation & Strategic Manager; Phone Number: 0113 34 34411; Email: dentcru@leeds.ac.uk

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS2 9LU
      • Recruiting
      • Leeds Dental Institute
      • Contact: Nuria Navarro Coy; Phone Number: 0113 34 34411; Email: n.navarro-coy@leeds.ac.uk
      • Contact: DenTCRU Operations & Strategic Manager; Phone Number: 0113 34 34411; Email: dentcru@leeds.ac.uk
      • Principal Investigator: Gillian Dukanovic
      • Principal Investigator: Ashna Chavda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients attending Leeds Dental Institute for tooth extraction.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Main endpoint: Antimicrobial survey	Antimicrobial survey	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.	Up to 2 hours before tooth extraction procedure

Collaborators and Investigators

• Sponsor: University of Leeds
• Collaborators: Oral and Dental Research Trust
• Investigators: Study Director: Sue Pavitt, PhD, University of Leeds

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 24, 2018
• Primary Completion (ANTICIPATED): August 23, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (ACTUAL): August 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 24, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: dental anxiety; antibiotic; oral health; tooth extraction
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: DT17/103574; 231858 (OTHER: IRAS); 18-WS-0111 (OTHER: Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No