Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2012-08-31
2013-06-30
Brief Summary
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The use of Isolite® system does not produce upper airway obstruction in the pediatric population during dental treatment with conscious sedation.
Purpose:
Report the changes in airway patency and pediatric patient's behavior when Isolite® system is used for dental treatment with conscious sedation.
Objectives:
1. Determine changes in pulse rate
2. Determine changes in SpO2
3. Recognize breath sound's changes possibly associated with airway blockage
4. Evaluate if the isolite® system is well tolerate by the pediatric population for dental treatment under conscious sedation
5. Relate the use of Isolite® with the frequency of head reposition to open the airway.
Detailed Description
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Conditions
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Keywords
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Study Design
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PROSPECTIVE
Interventions
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Isolite System
A type of isolation system used in dentistry. It protects soft tissues, and also has a mouth prop, which helps keep mouth open.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 4-7 years of age
* Patients English and Spanish speaking
Exclusion Criteria
* Craniofacial anomalies
4 Years
7 Years
ALL
Yes
Sponsors
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The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Claudia Isabel Contreras
Professor
Principal Investigators
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Claudia I Contreras, DDS
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Locations
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University of Texas Health Science Center-Dental School
San Antonio, Texas, United States
University of Texas Health Science Center-Ricardo Salinas Dental Clinic
San Antonio, Texas, United States
Countries
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References
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Kameyama A, Asami M, Noro A, Abo H, Hirai Y, Tsunoda M. The effects of three dry-field techniques on intraoral temperature and relative humidity. J Am Dent Assoc. 2011 Mar;142(3):274-80. doi: 10.14219/jada.archive.2011.0166.
Pena BM, Krauss B. Adverse events of procedural sedation and analgesia in a pediatric emergency department. Ann Emerg Med. 1999 Oct;34(4 Pt 1):483-91. doi: 10.1016/s0196-0644(99)80050-x.
Cote CJ, Karl HW, Notterman DA, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: analysis of medications used for sedation. Pediatrics. 2000 Oct;106(4):633-44. doi: 10.1542/peds.106.4.633.
Cote CJ, Notterman DA, Karl HW, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: a critical incident analysis of contributing factors. Pediatrics. 2000 Apr;105(4 Pt 1):805-14. doi: 10.1542/peds.105.4.805.
Noro A, Kameyama A, Asami M, Sugiyama T, Morinaga K, Kondou Y, Tsunoda M. Clinical usefulness of "Isolite Plus" for oral environment of Japanese people. Bull Tokyo Dent Coll. 2009 Aug;50(3):149-55. doi: 10.2209/tdcpublication.50.149.
Collette J, Wilson S, Sullivan D. A study of the Isolite system during sealant placement: efficacy and patient acceptance. Pediatr Dent. 2010 Mar-Apr;32(2):146-50.
American Academy on Pediatrics; American Academy on Pediatric Dentistry. Guideline for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. Pediatr Dent. 2008-2009;30(7 Suppl):143-59.
Leelataweedwud P, Vann WF Jr. Adverse events and outcomes of conscious sedation for pediatric patients: study of an oral sedation regimen. J Am Dent Assoc. 2001 Nov;132(11):1531-9; quiz 1596. doi: 10.14219/jada.archive.2001.0086.
Meurice JC, Marc I, Carrier G, Series F. Effects of mouth opening on upper airway collapsibility in normal sleeping subjects. Am J Respir Crit Care Med. 1996 Jan;153(1):255-9. doi: 10.1164/ajrccm.153.1.8542125.
MORIKAWA S, SAFAR P, DECARLO J. Influence of the headjaw position upon upper airway patency. Anesthesiology. 1961 Mar-Apr;22:265-70. doi: 10.1097/00000542-196103000-00016. No abstract available.
Verin E, Series F, Locher C, Straus C, Zelter M, Derenne JP, Similowski T. Effects of neck flexion and mouth opening on inspiratory flow dynamics in awake humans. J Appl Physiol (1985). 2002 Jan;92(1):84-92. doi: 10.1152/jappl.2002.92.1.84.
Dickison AE. The normal and abnormal pediatric upper airway. Recognition and management of obstruction. Clin Chest Med. 1987 Dec;8(4):583-96.
Iwatani K, Matsuo K, Kawase S, Wakimoto N, Taguchi A, Ogasawara T. Effects of open mouth and rubber dam on upper airway patency and breathing. Clin Oral Investig. 2013 Jun;17(5):1295-9. doi: 10.1007/s00784-012-0810-5. Epub 2012 Aug 3.
Ito H, Kawaai H, Yamazaki S, Suzuki Y. Maximum opening of the mouth by mouth prop during dental procedures increases the risk of upper airway constriction. Ther Clin Risk Manag. 2010 May 25;6:239-48. doi: 10.2147/tcrm.s10187.
Bingham RM, Proctor LT. Airway management. Pediatr Clin North Am. 2008 Aug;55(4):873-86, ix-x. doi: 10.1016/j.pcl.2008.04.004.
Other Identifiers
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HSC200120233H
Identifier Type: -
Identifier Source: org_study_id