Professional Documents
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Table of contents
TABLE OF CONTENTS ................................................................................................................. 1
1.
GLOSSARY .......................................................................................................................... 2
2.
INTRODUCTION ................................................................................................................ 2
3.
AIMS OF THE STUDY ......................................................................................................... 3
3.1. PRINCIPAL AIM ................................................................................................................. 3
3.2. SECONDARY AIM .............................................................................................................. 4
4.
EXPERIMENTAL DESIGN AND METHODOLOGY .................................................... 4
4.1. TYPE OF STUDY .................................................................................................................. 4
4.2. SELECTION OF GENERAL DENTISTS........................................................................... 5
4.3. SELECTION OF PATIENTS .............................................................................................. 5
4.4. NUMBER OF SUBJECTS NECESSARY ........................................................................... 5
4.5. SAMPLING METHODS ....................................................................................................... 5
4.6. CALIBRATON OF EXAMINERS ........................................................................
5
5.
INFORMATION TO BE COLLECTED ............................................................................. 6
6.
ORIGIN AND TYPE OF CATEGORICAL DATA TO BE COLLECTED .................... 6
6.1. DOCUMENTS TO BE COMPLETED ............................................................................... 6
7.
DATA MANAGEMENT ....................................................................................................... 7
7.1. STATISTICAL ANALYSIS ................................................................................................ 7
8.
ETHICAL CONSIDERATIONS ......................................................................................... 8
9.
BUDGET ................................................................................................................................. 9
10. TIMETABLE.......................................................................................................................... 9
11. SCIENTIFIC COUNCIL ...................................................................................................... 9
12. NATIONAL INSTITUTIONS.. .9
12. REFERENCES ...................... ...10
The non-carious dental cervical lesion and associated risk factors An observational, cross-sectional and multi-centre epidemiological study: 2010-2011
1. Glossary
BEWE
GDP
SD
BU
NCCL
OR
2. Introduction
All teeth are exposed to attrition by virtue of being in an environment which wears the teeth and may result
in cervical wear lesions. To different degrees, all dental surfaces are at risk of wear due to conditions
inherent in the oral environment, and it is generally agreed that their aetiology is multifactorial. Different
cervical lesion morphologies have been described corresponding to particular principal or even sole causes,
so that cervical lesions may be identified and quantified in epidemiological studies.
Non-carious cervical lesions progress constantly. Their high prevalence may be attributed to several factors
of which the most important are linked to oral hygiene practices and dietary habits; to these may be added
stress and its effects on the occlusion, and increases in population longevity.
Cervical wear lesions typically present for one of three reasons. The patient may well present
spontaneously because of hypersensitivity associated with the lesion or because of unaesthetic appearance,
or the condition may be detected at a routine dental examination, without the patient being aware of a
problem.
Clinical identification of the lesion will determine the diagnosis and govern the therapeutic decision.
Identification of aetiological factors will determine the prognosis of the lesion and suggest the treatment
plan. The latter should most definitely include preventing the aggravation of the symptoms and the lesions,
to facilitate the ultimate success of any restorative treatment.
Non-carious cervical lesions are generally linked to a combination of three basic mechanisms:
Mechanical Mechanisms: Abrasion of enamel, due to forceful brushing. This well recognised
mechanism may be accompanied by superficial gingival inflammation and gingival recession.
Mechanical mechanisms underlie also the loss of tissue due to flexion of the dental crown under
mechanical masticatory forces. Repeated flexion may lead to localised sub-surface tissue loss as pieces
of the tissue fracture off. Details of this mechanism for tissue loss remain controversial.
Chemical mechanisms: Erosion of dental calcified tissue under the influence of acids can occur; the
acids may be of dietary origin, or come from pharmaceutical products, or be linked to certain work
environments. Gastroesophageal reflux, which may affect up to 60% of people during their lives, may
also lead to erosions.
The multifactorial origin of these lesions makes it difficult to define exactly their aetiology. The difficulty
may be explained partly by the very wide differences in prevalence reported by different studies.
Today, it is nevertheless possible to narrow down the aetiology of non-carious cervical lesions by
identifying and analysing certain potential causal factors. These determining factors may be gleaned from:
- Questionnaires competed by affected persons covering hygiene habits, dietary habits and any
pathology or medication that could modify the pH of the oral environment or affect the buffering
capacity of saliva.
- Clinical records which provide information from ordinal indices on tooth wear, periodontal health
and the occlusion.
The non-carious dental cervical lesion and associated risk factors An observational, cross-sectional and multi-centre epidemiological study: 2010-2011
Few representative studies have examined the relationship between non-carious cervical lesions and
periodontal disease in subjects presenting with clinical loss of attachment. An observational clinical
epidemiological study would thus seem to be an appropriate public health response, for the following
reasons:
- Oral hygiene practices, and particularly brushing techniques, are key components in the
maintenance of good periodontal health. On the other hand, poorly applied, it is well established
that these factors can generate inflammation and gingival recession, frequently concomitant with
damage to calcified dental tissues.
- Periodontal conditions lead to cervical and radicular exposure (with clinical loss of attachment),
illustrating the aggressiveness of the oral environment and the damage due to brushing, to the
cement and the dentine which are 7 to 9 times less resistant than enamel.
- The consequences of these lesions, at the tooth-periodontal tissue interface, manifest themselves
functionally by dentinal-pulpal hypersensitivity and aesthetically when the lesions are on the
anterior teeth. These functional and aesthetic problems necessitate either restorative treatment or
periodontal plastic surgery.
Dentinal hypersensitivity is one of the first symptoms to appear after cervical wear lesions occur. It occurs
during the initial phases of an attack leading to cervical lesions. Epidemiological reports agree on an
approximate prevalence in adult populations of 10% to 20%. In this connection, dentinal hypersensitivity,
apart from having an impact on quality of life, seems to be the fundamental predictive risk factor for early
detection of non-carious cervical lesions and preventive interventions for these conditions.
If risk factors for non-carious cervical lesions have hitherto been poorly studied, better knowledge of these
conditions would allow the establishment of preventive measures that seek to reduce the incidence of this
condition and to diminish its impact, given that the condition has functional, aesthetic and painful
consequences that impact on the quality of life of adult sufferers. We are proposing to conduct a study,
using general dental practitioners, to identify risk factors for non-carious cervical lesions as diagnosed in
dental practice. Apart from the risk factors for acquiring non-carious cervical lesions, we hope to answer
questions about methods of management for the lesions, how is prevention organised, which preventive
strategy for which risk factors?
3. Aims of the study
3.1. Principal Aim
To research the risk factors associated with the occurrence of a non-carious cervical lesion in people aged
18-35 years included seen in general dentistry in Europe including Finland, France, Spain, Italy, Latvia,
Estonia, United Kingdom. *
Factors to be researched:
1.
Clinical loss of attachment
2.
Oral hygiene
3.
Dietary habits
4.
Tobacco and alcohol use
5.
Medical predispositions
6.
Life events during the preceding 12 months
* Turkey is inside the project as an associate partner. It performs the same study as methodological criteria, but the analysis, because of
technical constraints identified in a development phase of the protocol, will be delayed. The Czech Republic is also an associate member. The
methodology used in CZ is type CATI interview (by phone) including 700 adults. Only the questionnaire ESCARCEL project is used, no
clinical collection is performed.
The non-carious dental cervical lesion and associated risk factors An observational, cross-sectional and multi-centre epidemiological study: 2010-2011
The non-carious dental cervical lesion and associated risk factors An observational, cross-sectional and multi-centre epidemiological study: 2010-2011
The non-carious dental cervical lesion and associated risk factors An observational, cross-sectional and multi-centre epidemiological study: 2010-2011
This exercise should be conducted by a senior examiner. Part of the exercise may involve using
extracted teeth; however, the training exercise must include examining live subjects
3. 1/2 days of reliability assessment using live subjects presenting with non carious cervical with
severity ranging between 0 and 3 (BEWE). At least 15 patients should be examined per examiner
and the senior examiner
A senior examiner is a dentist with experience in using the BEWE, has high degree (Kappa = 0.75+) of
intra-examiner reliability, and has been calibrated and is reliable with another experienced BEWE
examiner. In some studies, a senior examiner may work concurrently with the other examiners to reach a
final decision. The term senior examiner (DB, AN) is used to refer to the standard which will be used to
compare with the findings of the examiners in a study.
Training
No.
of
Dentists
Estonia*
AN
10
France*
DB
15
Italy*
DB LO
17
Latvia*
DB/ES
10
Finland
AN
10
UK
DB
Spain
DB
20
Turkey
DB
10
Total
94
Training format:
(C) Conventional workshop using PowerPoint and discussion over clinical cases;
(E) Formation of national officers using training and standardisation toolkits;
(D) Formation of national epidemiologists
Training days: (DB) Denis Bourgeois; (LO) Livia Ottolenghi (AN) Annamari Nihtila; (ES) Egita Senekola.
*: Egohid Team (WWW.egohid.eu)
The agenda of the calibration session include 8 sections :
Section 1 Introduction
Section 2: Basic Erosive Wear Examination
Test calibration
Evaluation
Section 3: Hypersentivity, Schiff Index
Section 4 Periodontal Health Assessment
Test calibration
The non-carious dental cervical lesion and associated risk factors An observational, cross-sectional and multi-centre epidemiological study: 2010-2011
Evaluation
Section 5 Euro Oral Health Erosion Clinical Form
Section 6 Questionnaire
Section 7: Practical organisations
Section 8: Conclusions
The trained dentists then returned to their own practices and recruited patients for inclusion in the study
from their patients who had pre-existing appointments for dental examinations. National coordinator was in
charge to control the sampling plan and the evolution of the type and nature of patients included according
to the evolution of the quota. A hot line was initiated to assist GDP if necessary.
5. Information to be collected
The general dentists will recruit sequentially patients who agree to participate corresponding to the
eligibility criteria. The study is a cross-sectional observational epidemiological study taking place in (1)
metropolitan West of South England; (2) region of Bristol, England; (3) France, Italy, Latvia, Estonia at
national level; (4) region of Andalusia of Spain; (5) region of Helsinki in Finland.
Inclusion in the study: For every included participant, the general dentist should:
o Explain the study to the participant;
o Give the letter of information to the participant;
o Obtain his informed consent;
o Provide the participant with the self-completed questionnaire;
o Complete with the participant the dentist questionnaire which covers the participants clinical and
socio-demographic data.
The standardised clinical examination and interview will take place in connection with a routine check-up
in the practice of a private or public dental practitioner. The Sentinel general dentists will be requested
not to modify their treatment practices for these patients. This study must not modify the dentistpatient
relationship; the dentists remain free to choose the treatment of their choice and their follow-up. No out-ofthe-ordinary treatment or examination will be linked to this study
6. Origins and type of categorical data to be collected
The general dentists will recruit sequentially patients who agree to participate in accordance with to the
eligibility criteria and their willingness to participate and to complete the self-administered questionnaire.
6.1 Documents to be completed
When the participant is initially admitted to the study, the general dentist should complete a register
comprising: the participants initials; the age, sex, date of examination, included in the study (yes/no),
reason for exclusion. Once admitted to the study, the self administered questionnaire completed by the
patient and the clinical questionnaire will be provided; these will not include the participants name but
rather an identifying number made up of the dentists number and a sequence number for the participant.
The patientgeneral dentist questionnaire, completed by the dentist, will comprise:
Criteria of eligibility:
o Verification of the inclusion/exclusion criteria; age; date of consultation; socio-demographic data for
the patient; age, sex, professional activity, study level achieved, location.
Clinical data about non-carious cervical lesions:
o Evaluated using the Basic Erosive Wear Examination BEWE- Index on an ordinal scale ranging
from 0 to 3 (0=no erosive wear, 3=Wear with tissue loss on more than 50% of the surface);
o Localisation of the lesion (coronal, root surface or crown-root junction).
Clinical data about dentinal hypersensitivity:
o Evaluated by the Schiff index (ordinal scale, 0=no sensitivity, 3=continuous painful sensitivity on
stimulus) and on the dentinal hypersensitivity index (binary, 0 = yes, 1=no on stimulus).
The non-carious dental cervical lesion and associated risk factors An observational, cross-sectional and multi-centre epidemiological study: 2010-2011
Clinical data about periodontal conditions evaluated by (1) loss of attachment (mm); (2) depth of
periodontal pockets, and (3) presence or absence of gingival bleeding.
All information to collect data are involved in the booklet attached: Booklets Escarcel
The participants self-administered questionnaire, completed before the consultation, will include:
o Data on the participants oral hygiene practices;
o The participants Oral Health Related Quality of Life: this scale is a measurement tool comprising
questions; responses are made on a 4 point scale;
o Data on the participants perception of dentinal sensitivity: intensity, duration, origin.
o Data on the evaluation of risk factors associated with non-carious cervical lesions (tobacco,
medication, diet).
o Data on the evaluation of risk factors associated with non-carious cervical lesions: seeking aid in the
dental care system; health associated preventive behaviours (weight, size)
7. Data management
The data arising from the dentist questionnaire, completed by the dentist, will be recorded on a paper
form provided to the dentists at the commencement of the study. These paper forms will be returned to the
Sentinel network using a pre-paid reply envelope. The information from these forms will be entered on
computer using the EPIDATA programme and will form the database. The paper forms will be archived
with the other documents of this study.
The data arising from the patient self-completed questionnaire, on paper, will be returned to the
Sentinel network by the dentist using a pre-paid reply envelope by the general dentist. The information
from these forms will be entered on computer using the EPIDATA programme and added to the data base.
The paper forms will be archived with the other documents of this study. Responses to the patient-D and
patient self reported questionnaires in the data base will be identified by the sequence number and no
names will be recorded against the data item in the electronic file so created. At the end of the study, a
report with statistical tables and conclusions will be prepared for analysis and consideration of the findings
by the scientific council and those responsible for the project. A scientific report will be written. The data
will remain the property of the promoter of the study; all information published will be anonymous. Apart
from the report and the scientific publication, no sharing of the data is anticipated. The final report will be
published online on the internet site of the Sentinels network after the work has been published in medical
and scientific journals. Internet access to the information will be free to all.
7.1. Statistical analysis
The questionnaire data will be double entered to identify data entry errors and checked for logical
coherence. Analysis will be conducted using the R programme. All questionnaire items will be analysed.
Missing data will be flagged. The qualitative variables will be described and compared using the Chisquare test or Fishers Exact test if the former test is inappropriate. Quantitative variables will be described
and compared using the Wilcoxon test.
The analysis will be undertaken in two stages: a univariate analysis followed by a multivariate analysis.
The univariate analysis will estimate crude odds ratios, measuring separately the strength of association
between the disease and each of the exposure factors, without taking account of other potential
confounding factors. An odds ratio of 1.0 signifies the absence of an association. An odds ration
significantly greater than 1.0 implies that the exposure factor is a risk factor for the condition (disease)
while an odd ration significantly lower than 1.0 suggests that the exposure factor is a preventive factor for
the condition.
The non-carious dental cervical lesion and associated risk factors An observational, cross-sectional and multi-centre epidemiological study: 2010-2011
Multivariate analysis allows all the risk factors to be taken into account by simultaneously adjusting for
their effects. The standard analytical method for case control studies is multiple logistic regression analysis.
This method allows adjusted odds ratios (and their associated confidence intervals) to be estimated for each
exposure factor.
Odds ratios for risk factors associated with the different questionnaire items (dentinal sensitivity, erosion,
periodontal conditions, quality of life scales and dietary variables will be calculated in accordance with the
advice of the scientific committee.
8. Ethical Considerations
The refusal of the patient to participate in a study must never interfere with the physician-patient
relationship.
The design and performance of the study should be should be transmitted to a specially appointed
independent committee for consideration, comment and guidance in accordance with national
legislation. The protocol has been approved by the National Ethics Committee in each country.
9. Budget
Co-funding for this research study will be provided by GlaxoSmithKline Consumer Healthcare in the
context of an agreement for observational research with University Lyon1-EZUS, France.
10. Scientific Council
Pr. Denis Bourgeois, University Lyon1, France, European coordinator
Pr David Bartlett, Kings College University, London, United Kingdom
Pr. A. Lussi, University of Berne, Switzerland
Pr. Mariano Sanz, Computense University of Madrid, Spain
Pr. Ph. Bouchard, University Paris VII, France
Pr. N. West, University of Bristol, United Kingdom
11. National Institutions
Italy: University di Roma Sapienza
France: French Union for Oral Health UFSBD United Kingdom: University Bristol
United Kingdom : Kingstons College, London
Spain: University of Grenada
Turkey: National Dental Association; University of Ankara
Finland : Public Health National Service, Espoo
CZ: TNS Sofress
Estonia: National Dental Association
Latvia: University of Riga
12. Timetable
Stage 1: March-April 2010 Meeting of the scientific committee and finalisation of the protocol and
questionnaires; Stage 2: October-November 2010 Recruitment of the general dentists; Stage 3: January
2011; Launching of the study; June 2011: Termination of the study
13. References
1. Addy M. Dentine hypersensitivity: new perspectives on an old problem. Int Dent J 2002; 52:
367-375.
The non-carious dental cervical lesion and associated risk factors An observational, cross-sectional and multi-centre epidemiological study: 2010-2011
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The non-carious dental cervical lesion and associated risk factors An observational, cross-sectional and multi-centre epidemiological study: 2010-2011