Clinical Services

Our group represents a wide range of skills and expertise, offering the following clinical research services:

• The design, conduct and analysis of clinical trials of oral health care products according to ICH, GCP and ADA, FDA Standards.
• The design, co-ordination and analysis of international, national and regional epidemiological studies, including studies of minority or disadvantaged groups.
• The design, co-ordination and analysis of international, national and regional oral health services research studies, including studies of minority or disadvantaged groups.

A full service is available, including

• Trial design
• Protocol writing
• Application to the Clinical Research Ethics Committee and the Health Products Regulatory Authority
• Recruitment and screening of volunteers
• Stratification procedure
• Product dispensing and reconciliation
• Impartial interviewing techniques
• Validation procedure
• Microbiological measurements
• Biochemical tests
• Quality control
• Statistical analysis
• Report writing

All studies are performed in accordance with Good Clinical Practice guidelines.

Data Management
Staff at the centre have designed, directed and managed International, National and Regional Surveys of Oral Health since 1984. The sample size of our most recent National Survey was almost 20,000 children and adolescents. In addition to cross-sectional surveys and 3, 6 and 12 month randomised controlled clinical trials, we have conducted a 4 year prospective cohort study and a large-scale 3 year caries clinical trial involving approximately 4,000 children and adolescents.

Coordination of fieldwork, collation and cleaning of data, data processing, entry and analysis are provided in-house.

Statistical Services
Statistical analysis is typically carried out using the SAS statistical package, although other software is also available, including STATA and SPSS.  We have close links with the School of Mathematical Sciences, UCC.

Areas of Clinical Expertise
In-house clinical trials examiners are available on site. Our clinical expertise covers:  

• Caries: Backer-Dirks, Bennie, FOTI, Quantitative Laser Fluorescence, x-ray
• Enamel opacities: Thylstrup-and Fejerskov Index, Developmental Defects of Enamel Index, Quantitative Laser Fluorescence
• Gingivitis: Loe and Silness, MGI, Ainamo and Bay Gingival Bleeding Index
• Plaque: Turesky Modification of the Quigley Hein Index, Rustogi Modification of Navy Index
• Stain: Lobene Index, McPherson Modification of Lobene Index
• Sensitivity: Pressure (Yeaple probe), thermal (water at 5oC) and evaporative (air blast) stimuli. 

Visiting Examiners
The centre hosts visiting examiners as required.

Training and Calibration of Examiners
We have successfully trained and calibrated clinical trial examiners and national and international epidemiological examiners for oral health surveys. Courses are run on request.

Laboratory Services

Analytical laboratory support for our research is available in a number of large, well equipped laboratories on the University Campus. We collaborate with the Biosciences Institute and the Tyndall National Institute (TNI).

On site we have a dedicated, well-equipped laboratory with facilities for biochemical and microbiological research. This is used mainly for plaque pH studies and fluoride analysis.

Fluoride can be determined in foods, beverages, water, body fluids and body tissues.

Fluoride analytical methods available:

• Selective fluoride ion probe
• Ion chromatography
• Acid diffusion method

Fluoride concentration can be determined in:

• Beverages
• Bone
• Fingernails
• Foods
• Mouth rinses
• Saliva
• Toothpastes
• Urine
• Water

Salivary and plaque analysis are available.

We can offer:

• Capillary electrophoresis for determination of individual plaque acid concentrations
• Microbiological assay from first principles to determine the numbers and composition of microflora in various mediums