Salivary Antioxidant Capacity Before and After Complete Dental Rehabilitation

Sponsor

Riyadh Colleges of Dentistry and Pharmacy (Other)

Overall Status

Completed

CT.gov ID

NCT03432728

Collaborator

(none)

Enrollment

Location

23.2

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Dental Caries in Children	Procedure: Dental rehabilitation under general anesthesia

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 Design

Study Type:

Observational

Actual Enrollment :

40 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 25, 2016

Actual Primary Completion Date :

Jan 28, 2017

Actual Study Completion Date :

Dec 31, 2017

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Change in TAC after one week [One week]
Change in Total Salivary Antioxidant Capacity of children from baseline to one week after treatment
Change in TAC after Three months [Three months]
Change in Total Salivary Antioxidant Capacity of children from baseline to three months after treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Months to 72 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Riyadh Colleges of Dentistry and Pharmacy	Riyadh		Saudi Arabia

Sponsors and Collaborators

Riyadh Colleges of Dentistry and Pharmacy

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Sharat Pani, Program Director - Pediatric Dentistry, Riyadh Colleges of Dentistry and Pharmacy

ClinicalTrials.gov Identifier:

NCT03432728

Other Study ID Numbers:

FPGRP/ /43435005/126

First Posted:

Feb 14, 2018

Last Update Posted:

Feb 14, 2018

Last Verified:

Feb 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr Sharat Pani, Program Director - Pediatric Dentistry, Riyadh Colleges of Dentistry and Pharmacy

Antioxidant Capacity

Additional relevant MeSH terms:

Dental Caries

Anesthetics

Study Results

No Results Posted as of Feb 14, 2018