Salivary Antioxidant Capacity Before and After Complete Dental Rehabilitation

February 7, 2018 updated by: Dr Sharat Pani, Riyadh Colleges of Dentistry and Pharmacy

Salivary Antioxidant Capacity of Children With Severe Early Childhood Caries (S-ECC) Before and After Complete Dental Rehabilitation

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • Riyadh Colleges of Dentistry and Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in TAC after one week
Time Frame: 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
Time Frame: Three months
Change in Total Salivary Antioxidant Capacity of children from baseline to three months after treatment
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riyadh Colleges of Dentistry and Pharmacy

Investigators

  • Principal Investigator: Sharat C Pani, MDS, Riyadh Colleges of Dentistry and Pharmacy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2016

Primary Completion (Actual)

January 28, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

January 31, 2018

First Submitted That Met QC Criteria

February 7, 2018

First Posted (Actual)

February 14, 2018

Study Record Updates

Last Update Posted (Actual)

February 14, 2018

Last Update Submitted That Met QC Criteria

February 7, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPGRP/ /43435005/126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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