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Completed

NCT Number: NCT03432728

Salivary Antioxidant Capacity 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).

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Key information

Age range

60 month–72 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Riyadh Colleges of Dentistry and Pharmacy

Riyadh, Saudi Arabia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dental rehabilitation under general anesthesia

Procedure

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

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Riyadh Colleges of Dentistry and Pharmacy

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 14, 2018
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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