Condition category
Oral Health
Date applied
19/10/2012
Date assigned
07/11/2012
Last edited
17/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

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 measures

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

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

Sponsor information

Organisation

McGill University (Canada)

Sponsor details

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

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes