Plain English Summary
Background and study aims
Caries (also known as tooth decay or cavities are usually diagnosed on its cavitated stage and treated by drilling tooth tissue and applying a restorative material (like a filling). However, the restorations have their own life span and can be broken or lost with time. This will lead to re-restoration procedures, with subsequent tooth tissue loss. It is well known that the caries process includes several stages, from non-cavitated (early) to cavitated, and both stages can be active and inactive. Active caries should be treated, while in-active stages should not. Moreover, active non-cavitated caries can be treated and stopped using non-operative treatment. Therefore, using appropriate diagnostic criteria that can detect caries from their early stage, as well as assess their activity, is very important. Recently, two promising visual/visual-tactile caries diagnostic systems, the Nyvad and the ICDAS II were introduced. They have shown to be reliable and accurate and were used in several surveys and studies. However, since both systems have the potential to be used in clinical practice, it is important to investigate their implications on caries treatment decisions amongst dentists. The aim of this study is to compare the two different methods to how well they are used in caries treatment decision making in dentists.
Who can participate?
Dentists who are not aware about ICDAS II or Nyvad diagnostic systems and paitents aged 18 to 20 who have cavities
What does the study involve?
For the all dentists, a lecture concerning contemporary caries management strategies was given. Dentists are randomly assigned to one of two groups. Those in the first group use the Nyvad criteria in their first period and are followed up the ICDAS II criteria during the second period. Those in the second group use ICDAS II criteria during the first period and use the Nyvad criteria during the second period. Before the first period of examinations, dentists from the first group were trained with the Nyvad criteria, while dentists belonging to the second group were trained with the ICDAS II criteria. During the washout period, both groups of dentists were trained again: the first group with the ICDAS II criteria and the second group with the Nyvad criteria. After each examination, dentists were asked to make treatment decisions for each surface of the patients’ teeth.
What are the possible benefits and risks of participating?
Participating patients may benefit from receiving detailed information concerning their teeth and their oral health. They may benefit from receiving toothbrushes and fluoridated tooth pastes. Participating dentists may benefit from new knowledge in detecting and treating cavities. There are no notable risks with participating, however patients may experience some discomfort in their jaw during the dental examinations. Dentists may experience discomfort from repeated dental examiniations.
Where is the study run from?
This study is being run by McGill University and takes places in a dental unit of the Institute of Emergency Services of Belarus (Minsk, Belarus).
When is the study starting and how long is it expected to run for?
November 2010 to December 2010
Who is funding the study?
McGill University (Canada)
Who is the main contact?
Svetlana Tikhonova
svetlana.tikhonova@mail.mcgill.ca
Trial website
Contact information
Type
Scientific
Primary contact
Dr Svetlana Tikhonova
ORCID ID
Contact details
McGill University
4-3803 St-Hubert Str.
Montreal
H2L4A4
Canada
15142657624
svetlana.tikhonova@mail.mcgill.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
A12-E60-10A
Study information
Scientific title
A comparison of treatment choices when dental caries lesions are diagnosed with two visual-tactile systems the Nyvad and the ICDAS II
Acronym
Study hypothesis
1. A mean number of operative treatments estimated by dentists with the Nyvad system will be at least one unit less in comparison with the International Caries Detection and Assessment System (ICDAS) II system.
2. A mean number of non-operative treatments estimated by dentists with the Nyvad system will be at least three units less in comparison with the ICDAS II system.
Ethics approval
Institutional Review Board of McGill University, Montreal, Canada ref: A12-E60-10A, 2010
Research Ethics Committee of Belarusian State Medical University, 06 October 2010
Study design
Cross-over two-period (AB/BA) single blind clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
https://docs.google.com/open?id=0B4EyAvWIgprPWUQzMFJBZm9Bd3c
Condition
Dental caries
Intervention
The dentists were randomly assigned to one of two groups; each group had two dentists. Both groups of dentists examined the same patients (n=140) using the Nyvad and the ICDAS II criteria in different sequences. The first group used the Nyvad criteria during period 1, followed by ICDAS II criteria during period 2; the second group used the ICDAS II criteria during period 1, followed by Nyvad criteria during period 2. It was a one week washout period between period 1 and period 2 examinations. Before the first period of examinations, dentists from the first group were trained with the Nyvad criteria, while dentists belonging to the second group were trained with the ICDAS II criteria. During the washout period, both groups of dentists were trained again: the first group with the ICDAS II criteria and the second group with the Nyvad criteria. After each examination, dentists were asked to make treatment decisions for each surface of the patients teeth.
Deatils of co-sponsor:
Belarussian State Medical University
83, Dzerzinski Ave.
Minsk, Belarus 220116
Tel. +375 17 272 66 05
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Number of surfaces per individual requiring operative or non-operative treatment measured at the same time twice: in period 1 of examination and in a one week in period 2 of examination
Secondary outcome measures
Diagnostic outcomes:
1. Nyvad D and ICDAS II D components reflecting activity of the lesions (active non-cavitated lesions, active cavitated lesions, inactive non-cavitated lesions, inactive cavitated lesions).
2. Nyvad D and ICDAS II D (decay) components reflecting activity and depth of the lesions
3. Caries experience of carious lesions (mean DMFS) generated from the Nyvad and the ICDAS II systems
Overall trial start date
03/11/2010
Overall trial end date
05/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Dentists:
1. Dentists preliminary not aware about ICDAS II or Nyvad diagnostic systems
2. Five to ten years of clinical experience
3. The same university of graduation
4. Same specialization (operative dentistry)
5. Same clinical environment
6. Working with the same adult population (with similar caries prevalence and experience)
Patients:
1. Age of 18-20 years old
2. Males and females
3. Patients having ≥2 active non-cavitated and/or cavitated carious lesions
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
140
Participant exclusion criteria
Patients:
1. Caries inactive group (no or maximally one active lesion)
2. Patients with fixed orthodontic devices
3. Patients with severe fluorosis or hypoplasia
4. Patients with complicated chronic diseases that can produce modifications in treatment choosing
Recruitment start date
03/11/2010
Recruitment end date
05/12/2010
Locations
Countries of recruitment
Belarus
Trial participating centre
McGill University
Montreal
H2L4A4
Canada
Funders
Funder type
University/education
Funder name
McGill University (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list