Caries,DentalNCT03671200
Correlation Between Caries Experience in Primary Molars and First Permanent Molars
An observational study of Caries,Dental, run by Cairo University.
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… Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A convenient of Egyptian children aged 6-9 years attending the clinic of Pediatric Dentistry and dental public health Department, Faculty of Dentistry, Cairo University.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Correlation Between Caries Experience in Primary Molars and First Permanent Molars Among a Group of Egyptian Children: A Cross Sectional Study
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.
Read the 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
- Conditions
- Caries,Dental
- Keywords
- Primary teeth, Permanent first molar, Caries
- Medical subject headings
- Dental Caries
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data collection will be performed within one year from the starting date of the study.
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.
Measured: Data collection will be performed within one year from the starting date of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study startNov 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dema abdulhameed theyab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671200
- Sponsor's protocol ID
- CEBD-CU-2018-08-10
- Status last verified
- Sep 2018
- First submitted
- 8 Sep 2018
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Caries Experience in Primary Molars and First Permanent Molars Among a Group of Egyptian Children: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT03671200
- Acronym / sponsor ID
- CEBD-CU-2018-08-10
- Conditions
- Caries,Dental
- Keywords
- Primary teeth, Permanent first molar, Caries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A convenient of Egyptian children aged 6-9 years attending the clinic of Pediatric Dentistry and dental public health Department, Faculty of Dentistry, Cairo University.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Caries,Dental, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dema theyab, master (00201099246114, dema.theyab@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2018.