Isolite and Dental Treatment Under Conscious Sedation

NCT01683851 | Completed

• 1 other identifier: HSC200120233H
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Hypothesis 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. 1.Determine changes in pulse rate
2. 2.Determine changes in SpO2
3. 3.Recognize breath sound's changes possibly associated with airway blockage
4. 4.Evaluate if the isolite® system is well tolerate by the pediatric population for dental treatment under conscious sedation
5. 5.Relate the use of Isolite® with the frequency of head reposition to open the airway.

Conditions

Dental Caries

Keywords

pediatric; conscious sedation; mouthpiece; airway; isolite system

Outcome Measures

Primary Outcomes (1)

• Isolite and Dental Treatment Under Conscious Sedation

  In this study all patients were Mallampati 1 and Brodsky 2. The device comes in 4 sizes: pedo, small, medium and large. The most commonly used was pedo 65% (13) and small 35% (7). Eighty percent (16) of sedations had a satisfactory experience with Isolite ®, Twenty percent (4) had unsatisfactory outcome due to disruptive behavior. Of these 4 cases 2 patients were medicated with meperidine + hydroxyzine and the other 2 with midazolam. Fifty percent (8) of the patients successfully treated with Isolite ® experienced snoring and head reposition was performed to open airway. The level of sedation according to the AAPD guidelines was moderate in these events in which snoring occurred. The concentration of nitrous oxide-oxygen was adjusted so that more oxygen was given and the patient would be more alert. No significant changes in SpO2 (mean 99.8) or pulse were observed (mean 90.6).

  120 minutes (sedation appointment time)

Secondary Outcomes (1)

• Isolite and Dental Treatment Under Conscious Sedation

  120 minutes (sedation appointment)

Interventions

Isolite System DEVICE

A type of isolation system used in dentistry. It protects soft tissues, and also has a mouth prop, which helps keep mouth open.

Also known as: Isolite

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pediatric patients in need of a sedation dental appointment

You may qualify if:

• ASA I (no systemic disease), ASA II (mid systemic disease-well controlled)
• years of age
• Patients English and Spanish speaking

You may not qualify if:

• Upper airway infection
• Craniofacial anomalies

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (2)

University of Texas Health Science Center-Dental School

San Antonio, Texas, 78229, United States

Location

University of Texas Health Science Center-Ricardo Salinas Dental Clinic

San Antonio, Texas, 78237, United States

Location

Related Publications (15)

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  PMID: 21357861 BACKGROUND

• 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.

  PMID: 10499949 BACKGROUND

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  PMID: 11015502 BACKGROUND

• 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.

  PMID: 10742324 BACKGROUND

• 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.

  PMID: 19887758 BACKGROUND

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  PMID: 20483019 BACKGROUND

• 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.

  PMID: 19216414 BACKGROUND

• 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.

  PMID: 11811136 BACKGROUND

• 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.

  PMID: 8542125 BACKGROUND

• 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.

  PMID: 13772661 BACKGROUND

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  PMID: 11744646 BACKGROUND

• Dickison AE. The normal and abnormal pediatric upper airway. Recognition and management of obstruction. Clin Chest Med. 1987 Dec;8(4):583-96.

  PMID: 3322644 BACKGROUND

• 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.

  PMID: 22864529 BACKGROUND

• 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.

  PMID: 20526442 BACKGROUND

• 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.

  PMID: 18675024 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Claudia I Contreras, DDS

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 12, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 13, 2013

Record last verified: 2013-12

Locations

US (2)