NCT03671200

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

September 8, 2018

Last Update Submit

September 12, 2018

Conditions

Keywords

Primary teethPermanent first molarCaries

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 8, 2018

First Posted

September 14, 2018

Study Start

November 1, 2018

Primary Completion

November 1, 2019

Study Completion

January 1, 2020

Last Updated

September 14, 2018

Record last verified: 2018-09