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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03671200
Other study ID # CEBD-CU-2018-08-10
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 2018
Est. completion date January 2020

Study information

Verified date September 2018
Source Cairo University
Contact Dema theyab, master
Phone 00201099246114
Email dema.theyab@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A cross- sectional observational study which will investigate whether data of past caries experience of the primary molars of 6-9 years old children can serve as an indicator for caries development in first permanent molars.as the first permanent molars is selected to represent the future caries status of the permanent dentition.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 63
Est. completion date January 2020
Est. primary completion date November 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 9 Years
Eligibility Inclusion Criteria:

1. Children ages from six to nine years

2. Both sexes.

3. Parent and children cooperation.

4. Healthy children.

5. Children with sound and carious primary molars and erupted all of the first permanent molars.

Exclusion Criteria:

1. Children age under 6 or more than 9 years.

2. Children had a complex metabolic or medical disorder.

3. Parents that will not sign the consent.

4. Children with missing or unerupted first permanent molars.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary decay extracted filled primary teeth index (deft index) 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.
Primary decayed missing filled permanent teeth (DMFT index) 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.
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