Feasibility Testing of a New Way to Support the Jaw During 3rd Molar Extractions

Impacted Third Molar Tooth Clinical Trial

Official title:

The Restful Jaw Device: A New Way to Support and Protect the Jaw During Third Molar Extractions; Feasibility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03512769
• Other study ID #: 2854
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: August 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cross sectional observational study to assess the feasibility of using the functional prototype of the restful jaw support device to support the jaw when extracting mandibular 3rd molars using moderate/deep sedation. An additional meeting(s) will occur, after the oral and maxillofacial surgeons (OMS) have completed all treatment procedures utilizing the device and surveys are completed, to provide feedback on how the device performed.

Description:

Cross sectional observational study assesses the feasibility of OMS and dental assistants using the jaw support device during mandibular 3rd molar extractions with moderate/deep sedation.

Patients presenting for surgical removal of 3rd molars will be invited to participate in the study at the time of their oral surgery consult. The OMS will determine if the patient meets eligibility criteria, explain the study and invite them to participate. At the time of 3rd molar removal, the OMS and their dental assistants will follow their standard procedures for obtaining consent from patients for 3rd molar removal with moderate/deep sedation. In addition, they will confirm the patient's interest to participate in the study, ask if they have any questions and obtain consent. A dental assistant will place the jaw support device and recheck the jaw support tightening mechanism once the positioning is comfortable for the patient. The dental assistant will recheck the jaw support tightening mechanism before the procedure begins.

The OMS will use their standard protocol for removal of the teeth. The only change will be that a dental assistant who typically stands behind the dental chair and supports the mandible with their hands and moves the jaw as indicated by the OMS will instead place and secure the device to support the jaw. A dental assistant standing behind the chair will be present at all times to readjust the device position as needed or remove the device as indicated. The default in the case of device malfunction is for the device to fall away from the patient and the dental assistant will be immediately available to take over supporting the patient's jaw with their hands, which is one of their standard responsibilities when the device is not used.

Both the OMS and any dental assistant(s) assisting in the procedure(s), when the device is utilized, will each complete a survey about their experience with the jaw support device once they have completed surgical removal with moderate/deep sedation of mandibular 3rd molars in 4 patients.

An additional meeting(s) will occur, after the OMS have completed all treatment procedures utilizing the device and surveys are completed, to provide feedback on how the device performed. This information will inform Phase II of this study, a randomized controlled clinical trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

Inclusion Criteria:

• Is between 18 to 24 years of age.

• Requires surgical removal of bilateral mandibular 3rd molars (concurrent maxillary 3rd molar extractions allowed).

• Will consent to have 3rd molar surgical removal with the device supporting the mandible.

• Indication for moderate/deep sedation and medically able to tolerate sedation.

• American Society of Anesthesiologists (ASA) Physical Status Category I (healthy patient) and Category II (patients with mild systemic disease).

Exclusion Criteria:

• Any condition or situation that the surgeon feels would prevent the patient from participating in the study.

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome
• Tooth, Impacted

Intervention

Device:
• Restful Jaw Device
The Restful Jaw device is used to support the jaw during dental procedures including surgical removal of 3rd molars (wisdom teeth) with sedation. The device is designed to counter the downward forces placed on the mandible by clinicians during dental procedures and prevent jaw hyperextension (opening too wide) while providing a secure, stable jaw position. When 3rd molar teeth are surgically removed with sedation, a dental assistant stands behind the dental chair and supports the patient's jaw with both hands under the patient's jaw. If needed, the dental assistant also holds the jaw in a slightly forward position to maintain an open airway. This device replicates the dental assistant in holding the jaw during dental procedures.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	HealthPartners Institute

Country where clinical trial is conducted

United States, 

References & Publications (19)

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American Association of Oral and Maxillofacial Surgeons. Parameters of care: Clinical and practice guidelines for oral and maxillofacial surgeons. 2012. Available at http://www.mfch.cz/doc/ParCare2012Complete.pdf

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Fernandes P, Velly AM, Anderson GC. A randomized controlled clinical trial evaluating the effectiveness of an external mandibular support device during dental care for patients with temporomandibular disorders. Gen Dent. 2013 Sep-Oct;61(6):26-31. — View Citation

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Huang GJ, Cunha-Cruz J, Rothen M, Spiekerman C, Drangsholt M, Anderson L, Roset GA. A prospective study of clinical outcomes related to third molar removal or retention. Am J Public Health. 2014 Apr;104(4):728-34. doi: 10.2105/AJPH.2013.301649. Epub 2014 Feb 13. — View Citation

Huang GJ, Drangsholt MT, Rue TC, Cruikshank DC, Hobson KA. Age and third molar extraction as risk factors for temporomandibular disorder. J Dent Res. 2008 Mar;87(3):283-7. — View Citation

Huang GJ, LeResche L, Critchlow CW, Martin MD, Drangsholt MT. Risk factors for diagnostic subgroups of painful temporomandibular disorders (TMD). J Dent Res. 2002 Apr;81(4):284-8. — View Citation

Huang GJ, Rue TC. Third-molar extraction as a risk factor for temporomandibular disorder. J Am Dent Assoc. 2006 Nov;137(11):1547-54. — View Citation

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Juhl GI, Jensen TS, Norholt SE, Svensson P. Incidence of symptoms and signs of TMD following third molar surgery: a controlled, prospective study. J Oral Rehabil. 2009 Mar;36(3):199-209. doi: 10.1111/j.1365-2842.2008.01925.x. — View Citation

LeResche L, Mancl LA, Drangsholt MT, Huang G, Von Korff M. Predictors of onset of facial pain and temporomandibular disorders in early adolescence. Pain. 2007 Jun;129(3):269-78. Epub 2006 Nov 28. — View Citation

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Plesh O, Gansky SA, Curtis DA, Pogrel MA. The relationship between chronic facial pain and a history of trauma and surgery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1999 Jul;88(1):16-21. — View Citation

Pullinger AG, Monteiro AA. History factors associated with symptoms of temporomandibular disorders. J Oral Rehabil. 1988 Mar;15(2):117-24. — View Citation

Sahebi S, Moazami F, Afsa M, Nabavi Zade MR. Effect of lengthy root canal therapy sessions on temporomandibular joint and masticatory muscles. J Dent Res Dent Clin Dent Prospects. 2010 Summer;4(3):95-7. Epub 2010 Sep 16. — View Citation

Velly AM, Gornitsky M, Philippe P. Contributing factors to chronic myofascial pain: a case-control study. Pain. 2003 Aug;104(3):491-9. — View Citation

Zucuskie T. A controlled clinical trial of the usefulness of an external mandibular support device during routine dental care. Minneapolis: University of Minnesota; 1996.

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The feasibility will be assessed by query of the surgeons utilizing the device (questionnaire). This will be done after 4 patient experiences in conjunction with surgical procedure.	Surgeons satisfaction with utilization of the device.	3-6 months