NCT03432728

Brief Summary

Salivary samples were obtained from 20 children in their fifth year of life diagnosed S-ECC and 20 age and sex matched controls. Complete dental rehabilitation under general anesthesia was performed for the 20 children with S-ECC, and follow up salivary samples were obtained one week and three months post operatively. The TAC was measured using a commercially available Oxygen Radical Absorbance Antioxidant Assay measurement kit (Zen-Bio ORAC™, AMS Biotechnology, Abington UK).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 25, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
Last Updated

February 14, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

January 31, 2018

Last Update Submit

February 7, 2018

Conditions

Dental Caries in Children

Keywords

Antioxidant Capacity

Outcome Measures

Primary Outcomes (2)

  • Change in TAC after one week

    Change in Total Salivary Antioxidant Capacity of children from baseline to one week after treatment

    One week

  • Change in TAC after Three months

    Change in Total Salivary Antioxidant Capacity of children from baseline to three months after treatment

    Three months

Study Arms (2)

S-ECC

Children in their fifth year of life with severe early childhood caries Children selected will require complete dental rehabilitation under general anesthesia All enrolled children will receive treatment of all dental carious lesions under general anesthesia

Procedure: Dental rehabilitation under general anesthesia

Control

Children age and sex matched with the S-ECC group who are free of dental caries

Interventions

Dental rehabilitation under general anesthesiaPROCEDURE

Dental treatment of all teeth affected by dental caries in a single visit under general anesthesia

S-ECC

Eligibility Criteria

Age60 Months - 72 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

* Children who are on long term medications, * Children with chronic diseases * Children who have had an infection less than three weeks prior to collection of saliva

You may qualify if:

  • Medically fit children
  • Age below 71 months
  • Test group - to be diagnosed with severe ECC
  • Control group - to be caries free

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riyadh Colleges of Dentistry and Pharmacy

Riyadh, Saudi Arabia

Location

Study Officials

  • Sharat C Pani, MDS

    Riyadh Colleges of Dentistry and Pharmacy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director - Pediatric Dentistry

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 14, 2018

Study Start

January 25, 2016

Primary Completion

January 28, 2017

Study Completion

December 31, 2017

Last Updated

February 14, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)