Improving the Quality of Dentistry (IQuaD): Study comparing oral hygiene advice and periodontal instrumentation for the prevention and management of periodontal disease in dentate adults attending dental primary care | Recruiting
Improving the Quality of Dentistry (IQuaD): Study comparing oral hygiene advice and periodontal instrumentation for the prevention and management of periodontal disease in dentate adults attending dental primary care
IQuaD
Trial Source

Health Conditions
  • Oral and dental hygiene advice
Recruiting
Recruitment Status
ISRCTN56465715
Primary Trial ID Number
Summary
The aim of this study is to compare the effectiveness and cost-effectiveness of theoretically based, personalised oral hygiene advice (OHA) or periodontal instrumentation (PI) at different time intervals (no PI; 6 monthly PI or 12 monthly PI) or their combination to routine OHA, for improving periodontal health in dentate adults attending general dental practice. More details can be found at http://www.hta.ac.uk/project/2300.asp Protocol can be found at http://www.hta.ac.uk/protocols/200900010045.pdf On 14/08/2013 the anticipated end date was changed from 31/03/2016 to 31/12/2016.
Primary Outcome Measures
  • 1. Clinical: Gingival inflammation/bleeding on probing at the gingival margin measured using the Gingival Index of Loe by a trained blinded outcome assessor at baseline and 3 years follow-up
  • 2. Patient centred: Oral hygiene self-efficacy collected annually by questionnaire
  • 3. Economic: Net benefits (mean willingness to pay minus mean costs)
Secondary Outcome Measures
  • 1. Clinical: Calculus to the Ramfjord Calculus Index and periodontal pocket depth using the colour-coded UNC periodontal probe measured by a trained blinded outcome assessor at baseline and 3 years follow-up; additional periodontal instrumentation and referral
  • 2. Patient centred: dental quality of life, oral health behaviour, knowledge, cosmesis collected annually by questionnaire
  • 3. Economic: Costs to the National Health Service (NHS) and patients, willingness to pay
  • 4. Providers: Beliefs relating to giving oral hygiene advice and maintenance of periodontal health collected by questionnaire at baseline and 3 years follow-up
Research Question
  • The aim of this study is to compare the effectiveness and cost-effectiveness of theoretically based, personalised oral hygiene advice (OHA) or periodontal instrumentation (PI) at different time intervals (no PI; 6 monthly PI or 12 monthly PI) or their combination to routine OHA, for improving periodontal health in dentate adults attending general dental practice. More details can be found at http://www.hta.ac.uk/project/2300.asp Protocol can be found at http://www.hta.ac.uk/protocols/200900010045.pdf On 14/08/2013 the anticipated end date was changed from 31/03/2016 to 31/12/2016.
Design Type
Sorry, this information is not available
Ethics Approval
Fife and Forth Valley REC approved on 24/03/2011, ref: 10/S0501/65
Publications
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24160246
Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
1860
Participant Inclusion Criteria
  • 1. Adult patients, either sex (more than or equal to 18 years of age) with periodontal health, gingivitis or moderate periodontitis (BPE 0-3) who:
  • 1.1. Are dentate
  • 1.2. Have attended for a check-up at least twice in the previous 2 years
  • 1.3. Receive their dental care in part or fully as an NHS patient
Participant Exclusion Criteria
  • 1. Patients with periodontal disease with a Basic Periodontal Examination (BPE) score of 4 (probing depth > 6mm and/or furcation involvements or attachment loss of 7mm or more) in any sextant on the basis more extensive periodontal care is indicated
  • 2. Patients with an uncontrolled chronic medical condition (e.g. diabetes, immunocompromised)
Interventions
1. Dental practices will be randomised (cluster randomisation) to personalised oral hygiene advice (OHA) which will be tailored to the needs of the patient or routine OHA. 2. Subsequently participants will be randomised to one of three groups: 2.1. No periodontal instrumentation (PI) 2.2. 6 monthly PI 2.3. 12 monthly PI 3. Participants will be followed up annually by postal questionnaire for 3 years
Design Details
Sorry, this information is not available
Study Design
Randomised controlled trial
Results Reporting
Sorry, this information is not available
Acronym
IQuaD
Scientific Title
Improving the Quality of Dentistry (IQuaD): A multicentre randomised controlled trial comparing oral hygiene advice and periodontal instrumentation for the prevention and management of periodontal disease in dentate adults attending dental primary care
Secondary Trial Identifying Number
HTA : 09/01/45, 10273
Website
https://w3.abdn.ac.uk/hsru/IQuaD/
Study Funded By
NIHR Health Technology Assessment Programme - HTA (UK) (09/01/45)
Funder Type
Sorry, this information is not available
Study Sponsored By
University of Dundee (UK)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

01 Aug 2011

Recruitment End Date

31 Dec 2016

Trial End Date

31 Dec 2016

Date added to Registry

01 Aug 2011

Last Updated

30 Oct 2013