Testing two ways to diagnose tooth decay that will affect the way that dentists decide on treatment

ISRCTN ISRCTN65592532
DOI https://doi.org/10.1186/ISRCTN65592532
Secondary identifying numbers A12-E60-10A
Submission date
19/10/2012
Registration date
07/11/2012
Last edited
17/12/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Svetlana Tikhonova
Scientific

McGill University
4-3803 St-Hubert Str.
Montreal
H2L4A4
Canada

Phone 15142657624
Email svetlana.tikhonova@mail.mcgill.ca

Study information

Study designCross-over two-period (AB/BA) single blind clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet https://docs.google.com/open?id=0B4EyAvWIgprPWUQzMFJBZm9Bd3c
Scientific titleA comparison of treatment choices when dental caries lesions are diagnosed with two visual-tactile systems the Nyvad and the ICDAS II
Study objectives1. 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(s)Institutional Review Board of McGill University, Montreal, Canada ref: A12-E60-10A, 2010
Research Ethics Committee of Belarusian State Medical University, 06 October 2010
Health condition(s) or problem(s) studiedDental caries
InterventionThe 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 typeOther
Primary outcome measureNumber 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 measuresDiagnostic 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 study start date03/11/2010
Completion date05/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit20 Years
SexBoth
Target number of participants140
Total final enrolment140
Key inclusion criteriaDentists:
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
Key exclusion criteriaPatients:
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
Date of first enrolment03/11/2010
Date of final enrolment05/12/2010

Locations

Countries of recruitment

  • Belarus
  • Canada

Study participating centre

McGill University
Montreal
H2L4A4
Canada

Sponsor information

McGill University (Canada)
University/education

Faculty of Medicine
3655 Promenade Sir William Osler
Montreal, QC
H3G1Y6
Canada

ROR logo "ROR" https://ror.org/01pxwe438

Funders

Funder type

University/education

McGill University (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2014 17/12/2020 Yes No

Editorial Notes

17/12/2020: Publication reference and total final enrolment added.
08/06/2017: Plain English summary added.