Salivary Antioxidant Capacity Before and After Complete Dental Rehabilitation

Dental Caries in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03432728
• Other study ID #: FPGRP/ /43435005/126
• Status: Completed
• Phase: N/A
• First received: January 31, 2018
• Last updated: February 7, 2018
• Start date: January 25, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2018
• Source: Riyadh Colleges of Dentistry and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2017
• Est. primary completion date: January 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Months to 72 Months

Eligibility

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:

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

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

Locations

Country	Name	City	State
Saudi Arabia	Riyadh Colleges of Dentistry and Pharmacy	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Riyadh Colleges of Dentistry and Pharmacy

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in TAC after one week	Change in Total Salivary Antioxidant Capacity of children from baseline to one week after treatment	One week
Primary	Change in TAC after Three months	Change in Total Salivary Antioxidant Capacity of children from baseline to three months after treatment	Three months