Caries Assessment Clinical Trial
Official title:
Validity of International Caries Classification and Management System (ICCMS) Versus International Caries Detection and Assessment System (ICDAS ) in Caries Assessment : Invivo Diagnostic Study
1. A total of 40 volunteer patients will be assigned in this study.
2. All patients will be randomly selected with variable caries risks .
3. For each patient The Examiner will use Two screening methods used in caries detection ,
where D1 represents ICDAS index and D2 represents ICCMS index which are used by each
examiner for each patient.
4. Each examiner will record the dental findings using the visual- tactile assessment
method .The visual-tactile assessment method includes the use of mirror, probe under
good illumination condition
5. After full caries assessment in the 1st visit , All patients will receive full
treatment and oral hygiene control .
6. After 6-months follow up re-assessment of same patients will be done by same Examiners
.
7. The data of each examiner will be collected, and then the repeat-ability and the
reproducibility of each method as well as the inter- and intra-operator agreement will
be evaluated using the kappa statistics
- Number of visits & follow up period: There will be 2 visits and 6-months follow up
between 2 visits.
- Direct benefit of the research to the human volunteer:To get the most appropriate
treatment plan .
- Scientific Value and social benefits:obtain better information quality and support
Dentist Discussion making.
- Expected risk to human subjects:: the ordinary side effects associated with any
restorative treatment and no of the study variable has side effect on the patient
and in case of any side effect due to the restorative treatment , the participant
will directly contact the operator.
1. Study setting ----------------------------- The study will be conducted in Conservative
Dentistry Department, Faculty of Dentistry, Cairo University, The operator in charge
will be: Amr Sobhy Abd Elmounem The researcher will bear ultimate responsibility for
all activities associated with the conduct of a research project including recruitment
of patients, explaining and performing the procedures to them
2. Variables of the study
A total of 40 volunteer patients will be assigned in this study. For each patient Two
screening methods will be used in caries detection , where D1 represents ICDAS index
and D2 represents ICCMS index which are used by each examiner for each patient
3. Intervention/control assessment:
------------------------------------------- Each examiner will record the dental
findings using the visual- tactile assessment method .The visual-tactile assessment
method includes the use of mirror, probe under good illumination condition.
a. Control assessment: ICDAS
Any carious lesions detected are rated in score as the follow:
Code 0 Code 1 Code 2 Code 3 Code 4 Code 5 Code 6 .b. Intervention assessment:
(International Caries Classification and Management System):
Any carious lesions detected are rated in score as the follow:
Code 0 = ICDAS 0 Code A = ICDAS 1,2 Code B = ICDAS 3,4 Code C= ICDAS 4,6
4. Outcome assessment:
---------------------------------- Each examiner will record the dental findings using
both the intervention and control assessment method. Each method will be repeated twice
at the first visit and the other after 6 months after oral hygiene control to calculate
the repeat ability and reproducibility after and before treatment. The data of each
examiner will be collected, and then the repeatability and the reproducibility of each
method as well as the inter- and intra-operator agreement will be evaluated using the
kappa statistics.
5. Participant timeline:
------------------------------ All procedures will be carried out in two visits
6. Sample size calculation:
---------------------------------- A sample size of 40 subjects achieves 80% power to
detect an estimated Kappa value of 0.40; this power calculation is based on
significance level 5%. The sample size was calculated by PASS 2008
7. Recruitment & Recruitment Strategy:
-------------------------------------------------- Screening of patients that come to
the conservative dentistry department seeking dental care will continue until the
target population is achieved. The patients 'Oral condition will be subjected to visual
examination and diagnosis using dental charts. Once the patients that are potentially
eligible for this study are identified, they will be contacted by the research
investigator who will explain the study and ascertains the patient's interest. If
interested, more detailed evaluations and preparations are made.
8. Randomization and assignment of interventions:
--------------------------------------------------------------- No randomization will
be done as all patients will be examined by all examiners
Blinding:
The assessors will not be blind to intervention/control assessment methods. However it
will not be allowed among the examiners to exchange any information throughout the
entire study period.
9. Data collection methods:
---------------------------------- Caries will be assessed by both methods. Patients
with other dental work, not included in the study design, will be treated prior to
recruitment. Examiners will record the dental findings of the diagnosed fillings by
both intervention/control assessment methods on a dental chart.
10. Data management:
--------------------------- The data will be entered and stored on a personal computer.
Double data entry will be saved on an external hard disc to prevent loss of data
11. Statistical methods:
-------------------------------- Data will be analyzed using advanced statistics IBM
SPSS . Numerical data will be described as mean and standard deviation or median and
range. Categorical data will be described as numbers and percentages. Correlation
analysis will be used. Agreement between both methods will be analyzed with the use of
kappa statistics
12. Monitoring:
--------------------- A. Data monitoring: The main supervisor will monitor this study.
His role is to monitor any risk of bias could be done from participants
B. Harms:
The main researcher should inform participants about the possible harms, if present.
Participants are allowed to contact the main researcher at moment through telephone
C. Auditing:
In the present trial, auditing will be done by the main and co-supervisors to assure
quality of the research frequency procedures
13-Ethics and Dissemination:
1. Research ethics approval:
Application forms for carrying out the clinical trial, checklist and informed consent
of Research Ethics Committee (REC) Faculty of Oral and Dental Medicine, Cairo
University will be retrieved and filled, then will be delivered for (REC) committee for
approval. This is done to prevent any ethical problems during the study or any harm for
any of the participants.
2. Protocol amendments:
If a new protocol will be used a protocol amendment will be submitted; containing a new
copy of the new protocol and brief explanation about the differences between it and the
previous protocols. If there is a change in the existing protocol that affects safety
of subjects, investigation scope or scientific quality of the trial, an amendment
containing a brief explanation about the change will be submitted. If a new author will
be added to accomplish the study, an amendment including the investigator's data and
qualifications to conduct the investigation will be submitted to prevent ghost
authorship.
3. Consent:
The operator (Amr sobhy Abd elmounem) is responsible for admitting and signing the
written consents during the enrollment day.
4. Confidentiality:
Name, personal data and pictures of the participants will not appear on the protocol
form and will be maintained secured for 10 years after the trial. This is done for
protection of participants' privacy and civil rights.
5. Declaration of interests:
There is no conflict of interest, no funding or material supplying from any parties.
6. Access to data:
Access to final data will be allowed to the operator, the main and co-supervisors of
the study who are not involved in assessment of the outcome.
7. Dissemination policy:
Full protocol will be published online in www.clinicaltrials.gov to avoid repetition and to
keep the integrity of the research work. Thesis will be discussed in front of judgment
committee. The study will be published to report the results of this clinical trial.
14. Dissemination policy:
------------------------------- Full protocol will be published online in
www.clinicaltrials.gov to avoid repetition and to keep the integrity of the research
work.Thesis will be discussed in front of Judgment committee. The study will be published to
report the results of this clinical trial.
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