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Trial record 84 of 1201 for:    tooth decay

Neurodevelopment Outcomes After Pediatric Dental Caries Treatment Under General Anaesthesia

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ClinicalTrials.gov Identifier: NCT03002792
Recruitment Status : Not yet recruiting
First Posted : December 26, 2016
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Hui Zhang, Fourth Military Medical University

Brief Summary:
The purpose of this study is to investigate whether early expose to general anaesthesia will influence neurodevelopment.

Condition or disease Intervention/treatment
Anesthesia Procedure: general anesthesia

Detailed Description:
Participants, according to the state of illness and clinical requirements, assigned to receive dental caries treatment with or without general anesthesia. During the follow-up, various of neurodevelopment assessment will be done at specific timepoint to investigate whether general anaesthesia will influence neurodevelopment.

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Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurodevelopment Outcomes After Pediatric Dental Caries Treatment Under General Anaesthesia
Study Start Date : January 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Group/Cohort Intervention/treatment
general anesthesia
caries treatment under general anesthesia
Procedure: general anesthesia
nitrous oxide, sevoflurane, propofol, cisatracurium, fentanyl for induction and maintenance with sevoflurane

caries treatment only
caries treatment without general anesthesia



Primary Outcome Measures :
  1. Full Scale Intelligence Quotient (IQ) [ Time Frame: 24-28 weeks after enrollment ]
    according to Wechsler Preschool and Primary Scale of Intelligence fourth edition (WPPSI-IV)


Secondary Outcome Measures :
  1. Verbal Comprehension Index [ Time Frame: 24-28 weeks after enrollment ]
    according to WPPSI-IV

  2. Visual Spatial Index [ Time Frame: 24-28 weeks after enrollment ]
    according to WPPSI-IV

  3. Fluid Spatial Index [ Time Frame: 24-28 weeks after enrollment ]
    according to WPPSI-IV

  4. Working Memory Index [ Time Frame: 24-28 weeks after enrollment ]
    according to WPPSI-IV

  5. Processing Speed Index [ Time Frame: 24-28 weeks after enrollment ]
    according to WPPSI-IV

  6. Executive Function [ Time Frame: 24-28 weeks after enrollment ]
    according to Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P)

  7. Adaptive Behavior [ Time Frame: 24-28 weeks after enrollment ]
    according to Adaptive Behavior Assessment System second edition

  8. Emotion Comprehension [ Time Frame: 24-28 weeks after enrollment ]
    according to Test of Emotion Comprehension(TEC) (designed by Pons & Harris ,2000)



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients revieve carves treatment in Department of Pediatric Dentistry,School of Stomatology, the Fourth Military Medical University
Criteria

Inclusion Criteria:

  • Gestational age>=36 weeks
  • American Society of Anesthesiologists(ASA) physical status Ⅰ or Ⅱ,with very limited systemic disease.
  • Age<=6 yr

Exclusion Criteria:

  • did not provide research authorization;
  • unable to contact or inconvenient for follow-up;
  • hypersensitive to general anesthesia drug;
  • previous exposure to general anesthesia in utero;
  • previous exposure to general anesthesia as a neonate
  • previous exposure to psychotropic medication;
  • complications at birth such as low weigh, hypoxia, or cerebral edema;
  • any other known diseases may influence the neurodevelopment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002792


Contacts
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Contact: Hui Zhang, M.D. (+86)029-84776119 zhanghuifmmua@163.com

Locations
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China, Shaanxi
School of Stomatology, the Fourth Military Medical University Not yet recruiting
Xi'an, Shaanxi, China, 710032
Contact: Xin Qi, Postgraduate    (+86)029-84776230    qixin-166@163.com   
Contact: Bing Liu, Master    (+86)029-84776230    adalb729@163.com   
Principal Investigator: Hui Zhang, M.D.         
Principal Investigator: Guoliang Zhang, M.D.         
Principal Investigator: Wei Wang, M.D.         
Principal Investigator: Rui Lu, Master         
Principal Investigator: Lirong Liang, Postgraduate         
Sponsors and Collaborators
Fourth Military Medical University
Investigators
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Study Director: Hui Zhang, M.D. School of Stomatology, the Fourth Military Medical University

Publications:

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Responsible Party: Hui Zhang, M.D., Ph.D. Director and Professor, Department of Anaesthesiology, School of Stomatology, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT03002792     History of Changes
Other Study ID Numbers: 2014KTCL03_05
First Posted: December 26, 2016    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Hui Zhang, Fourth Military Medical University:
anesthesia
neurodevelopment
dental caries

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs