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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:
Report the changes in airway patency and pediatric patient's behavior when Isolite® system is used for dental treatment with conscious sedation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Isolite and Dental Treatment Under Conscious Sedation | Finally, it is important to recognize that this is a pilot study with limitations, including:
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:
Therefore, this study's findings need to be tempered by implications contained within these limitations and further research seems indicated. |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients in need of a sedation dental appointment
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| Name | Affiliation | Role |
|---|---|---|
| Claudia I Contreras, DDS | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center-Dental School | San Antonio | Texas | 78229 | United States | ||
| University of Texas Health Science Center-Ricardo Salinas Dental Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21357861 | Background | 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. | |
| 10499949 | 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. |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| 120 minutes (sedation appointment) |
| San Antonio |
| Texas |
| 78237 |
| United States |
| 11015502 | Background | 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. |
| 10742324 | 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. |
| 19887758 | 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. |
| 20483019 | Background | 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. |
| 19216414 | 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. |
| 11811136 | 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. |
| 8542125 | 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. |
| 13772661 | 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. |
| 11744646 | Background | 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. |
| 3322644 | Background | Dickison AE. The normal and abnormal pediatric upper airway. Recognition and management of obstruction. Clin Chest Med. 1987 Dec;8(4):583-96. |
| 22864529 | 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. |
| 20526442 | 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. |
| 18675024 | 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. |