Salivary Antioxidant Capacity Before and After Complete Dental Rehabilitation

NCT ID: NCT03432728

Last Updated: 2018-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-25

Study Completion Date

2017-12-31

Brief Summary

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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).

Detailed Description

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Background: The association of total salivary antioxidant capacity (TAC) to severe early childhood caries (S-ECC) has been studied in the past. It is not clear if TAC is an indicator of the inflammatory response to the lesion or a marker of the disease.

Aim: This study aimed to measure the salivary TAC levels in children with early childhood caries before and after dental treatment and compare the results to caries free children.

Methodology: Salivary samples were obtained from 20 children in their fifth year of life diagnosed S-ECC and 20 age and gendersex 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).

Conditions

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Dental Caries in Children

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Dental rehabilitation under general anesthesia

Intervention Type PROCEDURE

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

Control

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

No interventions assigned to this group

Interventions

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Dental rehabilitation under general anesthesia

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

60 Months

Maximum Eligible Age

72 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Riyadh Colleges of Dentistry and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Dr Sharat Pani

Program Director - Pediatric Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sharat C Pani, MDS

Role: PRINCIPAL_INVESTIGATOR

Riyadh Colleges of Dentistry and Pharmacy

Locations

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Riyadh Colleges of Dentistry and Pharmacy

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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FPGRP/ /43435005/126

Identifier Type: -

Identifier Source: org_study_id

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