NCT05607251

Brief Summary

Aim of the study:

  1. 1.Assess the correlation between salivary alkaline phosphatase levels and dental caries.
  2. 2.Assess the effect of growth of children on the levels of salivary alkaline phosphatase enzyme.
  3. 3.Assess the effect of growth of children on caries experience and severity.

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
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

November 1, 2022

Last Update Submit

November 1, 2022

Conditions

Dental Caries in Children

Outcome Measures

Primary Outcomes (1)

  • Salivary Alkaline Phosphatase levels in children with and without dental caries

    Measured by spectrophotometry (unit: U/L)

    2 months

Secondary Outcomes (2)

  • Caries index

    2 months

  • Caries severity

    2 months

Interventions

No interventionOTHER

There is no intervention as this is an observational study

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children aged between 6-8 years.

You may qualify if:

  • Children aged 6 to 8 years old.
  • Children with and without previous dental visits.

You may not qualify if:

  • Children with any systemic or mental illness.
  • Children whose parents refuse to sign the informed consent.
  • Children who will not cooperate on participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Dentist

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 7, 2022

Study Start

January 1, 2023

Primary Completion

March 1, 2023

Study Completion

April 1, 2023

Last Updated

November 7, 2022

Record last verified: 2022-11