Isolite and Dental Treatment Under Conscious Sedation

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683851
• Other study ID #: HSC200120233H
• Status: Completed
• Phase: N/A
• First received: September 7, 2012
• Last updated: December 12, 2013
• Start date: August 2012
• Est. completion date: June 2013

Study information

• Verified date: December 2013
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical 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.

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 7 Years

Eligibility

Inclusion Criteria:

• ASA I (no systemic disease), ASA II (mid systemic disease-well controlled)

• 4-7 years of age

• Patients English and Spanish speaking

Exclusion Criteria:

• Upper airway infection

• Craniofacial anomalies

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

References & Publications (15)

American Academy of Pediatrics; American Academy of Pediatric Dentistry, Coté CJ, Wilson S; Work Group on Sedation. Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures: an update. Pediatrics. 2006 Dec;118(6):2587-602. — View Citation

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. Review. — View Citation

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. — View Citation

Coté 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. — View Citation

Coté 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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Meurice JC, Marc I, Carrier G, Sériès 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. — View Citation

MORIKAWA S, SAFAR P, DECARLO J. Influence of the headjaw position upon upper airway patency. Anesthesiology. 1961 Mar-Apr;22:265-70. — View Citation

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. — View Citation

Peña 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. — View Citation

Verin E, Sériès 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Isolite and Dental Treatment Under Conscious Sedation	Finally, it is important to recognize that this is a pilot study with limitations, including: A small number of participants; 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: Isolite ® may be safely used during pediatric dental treatment under conscious sedation.; 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.	120 minutes (sedation appointment)	No