N/A
N=171
Assessing a New Jaw Support Device During Third Molar Extractions
Impacted Third Molar Tooth · Temporomandibular Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03975920 ↗Enrolled (actual)
171
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Occurrence of Pain at Follow-up With Wide Opening, or Pain in the Temple, Jaw Joint or Jaw Muscles. — 26; 32; 54; 53 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The Restful Jaw Device (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Pain at Follow-up With Wide Opening, or Pain in the Temple, Jaw Joint or Jaw Muscles. |
16; 21; 64; 62 | — |
| PRIMARY Occurrence of Pain at Follow-up With Wide Opening, or Pain in the Temple, Jaw Joint or Jaw Muscles. |
16; 21; 64; 62 | — |
| PRIMARY Occurrence of Pain at Follow-up With Wide Opening, or Pain in the Temple, Jaw Joint or Jaw Muscles. |
16; 21; 64; 62 | — |
| SECONDARY Occurrence of Pain Related TMD at Follow-up Using the TMD Pain Screener Questionnaire. |
6; 5; 74; 75 | — |
| SECONDARY Occurrence of Pain Related TMD at Follow-up Using the TMD Pain Screener Questionnaire. |
6; 5; 74; 75 | — |
| SECONDARY Occurrence of Pain Related TMD at Follow-up Using the TMD Pain Screener Questionnaire. |
6; 5; 74; 75 | — |
| SECONDARY Intensity of Pain at Follow-up Using the Characteristic Pain Index (CPI). |
2.5; 4.9 | — |
| SECONDARY Intensity of Pain at Follow-up Using the Characteristic Pain Index (CPI). |
2.5; 4.9 | — |
| SECONDARY Intensity of Pain at Follow-up Using the Characteristic Pain Index (CPI). |
2.5; 4.9 | — |
| SECONDARY Occurrence of TMJ Noise at Follow-up Using Self Report. |
12; 15; 67; 68 | — |
| SECONDARY Occurrence of TMJ Noise at Follow-up Using Self Report. |
12; 15; 67; 68 | — |
| SECONDARY Occurrence of TMJ Noise at Follow-up Using Self Report. |
12; 15; 67; 68 | — |
| SECONDARY Change in Jaw Pain at Follow-up Using Self-report. |
7; 8; 0; 4; 8; 8 | — |
| SECONDARY Change in Jaw Pain at Follow-up Using Self-report. |
7; 8; 0; 4; 8; 8 | — |
| SECONDARY Change in Jaw Pain at Follow-up Using Self-report. |
7; 8; 0; 4; 8; 8 | — |
Summary
During mandibular 3rd molar (wisdom tooth) extractions, when a downward force is placed on the patient's jaw, the patient must tense his/her jaw muscles to oppose it. Patients under moderate/deep sedation or general anesthesia cannot tense their muscles to counter this downward force to prevent injury to the jaw including the temporomandibular joint (TMJ). Bite blocks hold the patient's mouth open but do not counter this downward force on the mandible. Currently, oral and maxillofacial surgeons (OMSs) when surgically removing 3rd molars (wisdom teeth) with moderate/deep sedation or general anesthesia have a dental assistant that stands behind the chair and places their hands on both sides of the jaw to support it and oppose the downward force on the patient's jaw during the extractions. It is hard for the dental assistant to maintain support while anticipating the direction and amount of force placed by the OMS on the patient's jaw during the surgical removal. This may explain the finding that almost a quarter of new onset TMD cases in young adults is associated with 3rd molar removal. This study will look at the use of a jaw support device to provide a stable counterforce to downward forces on the jaw, thus preventing jaw hyperextension and injury to the jaw.
Eligibility Criteria
Inclusion Criteria
- Between 18 to 30 years of age at time of enrollment;
- Willing to provide informed consent to be randomized to either using the device or not when having surgical removal of 3rd molars with moderate/deep sedation or general anesthesia;
- Requires surgical removal of bilateral mandibular 3rd molars with moderate/deep sedation or general anesthesia; concurrent maxillary 3rd molars removal allowed;
- American Society of Anesthesiologists (ASA) Physical Status category 1 (normal healthy patient) or Category 2 (patient with mild systemic disease);
- Available to be contacted for study purposes by e-mail, phone and/or text;
- Willing to provide contact information for one other person who will know the patient's whereabouts in the event the patient cannot be reached. This contact information must be different from the patient's contact information;
- Willing to comply with all study procedures and be available for the six month duration of data collection.
Exclusion Criteria
- In the past 3 months, reports the presence of TMD pain in their temples, jaw joints or jaw muscles;
- Contraindication(s) for moderate/deep sedation or general anesthesia;
- Any condition or situation the surgeon determines that would prevent the patient from participating in this study;
- Inability to understand study procedures or provide consent in English;
- Device does not fit mandible;
- Supernumerary 3rd molars present.
Data sourced from ClinicalTrials.gov (NCT03975920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.