- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03671200
Correlation Between Caries Experience in Primary Molars and First Permanent Molars
Correlation Between Caries Experience in Primary Molars and First Permanent Molars Among a Group of Egyptian Children: A Cross Sectional Study
Study Overview
Status
Conditions
Detailed Description
Study Design:
A cross sectional study to investigate if there is any correlation between caries experience in primary molars and first permanent molars among a group of Egyptian children. All the procedures will be explained to the parents or guardians prior to the investigation.An informed consent will be signed by the parents Study design: cross sectional study design. Data for this particular study will be collected from the clinic of Pediatric Dentistry and dental public health Department, Faculty of Dentistry, Cairo University.
Methods Clinical examination will be carried out while the child is sitting on dental unit, using sterile diagnostic set (mirror and explorer) in daylight. No diagnostic radiographs will be taken.
A custom-made examination chart will be filled for each child including date, name, age, address, gender, medical history and previous dental treatment. Parents data includes: level of education and oral hygiene level.
Prior to performing dental examination, the child will be asked to rinse his mouth with tap water and the teeth will be cleaned with sterile cotton.
The examiner will carefully inspect all surfaces of the teeth, for proper diagnosis, the teeth were dried thoroughly with an air syringe. It will be important to see clearly and to use the air syringe to distinguish readily cervical or interproximal caries.
All the primary teeth will be evaluated using deft index and permanent teeth will be evaluated using DMF index, both according to WHO criteria.
(WHO, 2003) criteria: Clinical caries lesion shows the following criteria
Lesion in pit or fissure, or on a smooth tooth surface with cavitated undermined enamel, or a detectably softened floor or wall.
Teeth with recurrent dental caries. In cases where the crown has been destroyed by caries and only the root is left, the caries is judged to be crown caries.
Lesions not considered as clinical dental caries White or chalky spots (early carious lesion). Stained enamel pits or fissures without visible cavitation or soft floor or walls during examination by sharp explorer.
Dark, shiny, hard, pitted areas of enamel in a tooth showing signs of moderate to severe enamel fluorosis.
Each child and parents will be given two printed sheet translated into Arabic, after the end of the diagnosis, which will include his/her caries status, the right oral hygiene method to be followed in order to maintain a good oral health status and any caries lesions that need treatment by restorative material or preventive measures
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children ages from six to nine years
- Both sexes.
- Parent and children cooperation.
- Healthy children.
- Children with sound and carious primary molars and erupted all of the first permanent molars.
Exclusion Criteria:
- Children age under 6 or more than 9 years.
- Children had a complex metabolic or medical disorder.
- Parents that will not sign the consent.
- Children with missing or unerupted first permanent molars.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
decay extracted filled primary teeth index (deft index)
Time Frame: Data collection will be performed within one year from the starting date of the study.
|
caries experience in primary molars.
Clinical examination will be performed at once for each patient, the examination will be done in the clinic using an explorer and mirror after drying the teeth to detect the presence of caries in the upper and lower primary molars.
|
Data collection will be performed within one year from the starting date of the study.
|
|
decayed missing filled permanent teeth (DMFT index)
Time Frame: Data collection will be performed within one year from the starting date of the study.
|
Caries experience in first permanent molars.Clinical examination will be performed at once for each patient, the examination will be done in the clinic using an explorer and mirror after drying the teeth to detect the presence of caries in the upper and lower permanent first molars.
|
Data collection will be performed within one year from the starting date of the study.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBD-CU-2018-08-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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