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Dental CariesNCT01683851

Isolite and Dental Treatment Under Conscious Sedation

An observational study of Dental Caries, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 7 yearsHealthy volunteers can take part
Conditions the study is for
Dental Caries
What is being tested?
Isolite System
Type of treatment
Medical device
How many people
20 participants
Where
2 sitesUnited States
Study dates
Aug 2012to Jun 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 7 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Pediatric patients in need of a sedation dental appointment

Who may be able to join

  • ASA I (no systemic disease), ASA II (mid systemic disease-well controlled)
  • 4-7 years of age
  • Patients English and Spanish speaking

Who cannot join

  • Upper airway infection
  • Craniofacial anomalies

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Texas Health Science Center-Dental School

    San Antonio, Texas, 78229

  • University of Texas Health Science Center-Ricardo Salinas Dental Clinic

    San Antonio, Texas, 78237

Other trials in United States

About this study

Official title: Isolite and Dental Treatment Under Conscious Sedation: a Pilot Study to Assess the Upper Airway in a Pediatric Population

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. 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.
Read the detailed description

Report the changes in airway patency and pediatric patient's behavior when Isolite® system is used for dental treatment with conscious sedation.

Conditions
Dental Caries
Being tested
Isolite System
Keywords
pediatric, conscious sedation, mouthpiece, airway, isolite system
Medical subject headings
Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Isolite SystemDevice

    Also called Isolite

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 120 minutes (sedation appointment time)

Secondary outcomes (1)

  1. Isolite and Dental Treatment Under Conscious Sedation

    Finally, it is important to recognize that this is a pilot study with limitations, including:

    1. A small number of participants
    2. No group control

    Therefore, this study's findings need to be tempered by implications contained within these limitations and further research seems indicated.

    Conclusions:

    The results of this pilot study suggest the following conclusions:

    1. Isolite ® may be safely used during pediatric dental treatment under conscious sedation.
    2. The successful use of Isolite ® is related to the patient's behavior. The weakness aspect of Isolite ® is the soft bite block that allows the youngest patients to chew on it.

    Therefore, this study's findings need to be tempered by implications contained within these limitations and further research seems indicated.

    Measured: 120 minutes (sedation appointment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01683851
Sponsor's protocol ID
HSC200120233H
Status last verified
Dec 2013
First submitted
7 Sep 2012
Last updated
13 Dec 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21357861

  • 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.

    PubMed 10499949

  • 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.

    PubMed 11015502

  • 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.

    PubMed 10742324

  • 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.

    PubMed 19887758

  • 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.

    PubMed 20483019

  • 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.

    PubMed 19216414

  • 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.

    PubMed 11811136

  • 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.

    PubMed 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.

    PubMed 13772661

  • 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.

    PubMed 11744646

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

    PubMed 3322644

  • 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.

    PubMed 22864529

  • 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.

    PubMed 20526442

  • 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.

    PubMed 18675024

Questions about this trial

What is this clinical trial studying?

An observational study of Dental Caries, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Isolite and Dental Treatment Under Conscious Sedation (time frame: 120 minutes (sedation appointment time)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01683851, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2013.

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