Trial Outcomes & Findings for Assessing a New Jaw Support Device During Third Molar Extractions (NCT NCT03975920)
NCT ID: NCT03975920
Last Updated: 2022-06-06
Results Overview
The primary outcome is the self-report of the occurrence of TMD pain post-baseline. All subjects were pain-free at baseline (i.e., pre-surgically) for TMD pain. TMD pain is deemed to have occurred if the subject's self report endorses at 1, 3 or 6 months post-baseline either or both of the following questions: 1. Pain in jaw when opening mouth wide or 2. Pain in temples, jaw joints or jaw muscles.
COMPLETED
NA
180 participants
1 Month
2022-06-06
Participant Flow
Participants were recruited at an academic institution, 2 clinics that are a part of a large group practice, and a clinic in the community between June 2019 and August 2020. The first participant was enrolled on June 25, 2019 and the last participant was enrolled on August 27, 2020.
A total of 180 participants were enrolled through consult and surgical appointments for removal of wisdom teeth. Nine (9) participants were not randomized due to change in anesthesia or were unable to complete their procedure prior to enrollment closure. 171 participants were randomized into the study; of those, 2 were removed from the study due to protocol deviations (determined did not meet inclusion criteria).
Participant milestones
| Measure |
Usual Care (UC)
The study control is Usual Care (UC), which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
|
Experimental Care (EC)
The study intervention for Experimental Care (EC) is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.
The 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. This device replicates the dental assistant in holding the jaw during dental procedures.
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
87
|
|
Overall Study
1-Month Follow-up Survey
|
80
|
85
|
|
Overall Study
3-Month Follow-up Survey
|
78
|
84
|
|
Overall Study
6-Month Follow-up Survey
|
80
|
83
|
|
Overall Study
COMPLETED
|
80
|
83
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Usual Care (UC)
The study control is Usual Care (UC), which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
|
Experimental Care (EC)
The study intervention for Experimental Care (EC) is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.
The 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. This device replicates the dental assistant in holding the jaw during dental procedures.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Did not complete survey
|
2
|
1
|
Baseline Characteristics
Assessing a New Jaw Support Device During Third Molar Extractions
Baseline characteristics by cohort
| Measure |
Usual Care (UC)
n=83 Participants
The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
|
Experimental Care (EC)
n=86 Participants
The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.
The 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. This device replicates the dental assistant in holding the jaw during dental procedures.
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
83 Participants
n=93 Participants
|
86 Participants
n=4 Participants
|
169 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Customized
18-30 years
|
83 Participants
n=93 Participants
|
86 Participants
n=4 Participants
|
169 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
109 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
140 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
112 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
83 participants
n=93 Participants
|
86 participants
n=4 Participants
|
169 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 MonthThe primary outcome is the self-report of the occurrence of TMD pain post-baseline. All subjects were pain-free at baseline (i.e., pre-surgically) for TMD pain. TMD pain is deemed to have occurred if the subject's self report endorses at 1, 3 or 6 months post-baseline either or both of the following questions: 1. Pain in jaw when opening mouth wide or 2. Pain in temples, jaw joints or jaw muscles.
Outcome measures
| Measure |
Usual Care (UC)
n=80 Participants
The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
|
Experimental Care (EC)
n=85 Participants
The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.
The 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. This device replicates the dental assistant in holding the jaw during dental procedures.
|
|---|---|---|
|
Occurrence of Pain at Follow-up With Wide Opening, or Pain in the Temple, Jaw Joint or Jaw Muscles.
Pain reported at 1 month
|
26 Participants
|
32 Participants
|
|
Occurrence of Pain at Follow-up With Wide Opening, or Pain in the Temple, Jaw Joint or Jaw Muscles.
No pain reported at 1 month
|
54 Participants
|
53 Participants
|
PRIMARY outcome
Timeframe: 3 MonthThe primary outcome is the self-report of the occurrence of TMD pain post-baseline. All subjects were pain-free at baseline (i.e., pre-surgically) for TMD pain. TMD pain is deemed to have occurred if the subject's self report endorses at 1, 3 or 6 months post-baseline either or both of the following questions: 1. Pain in jaw when opening mouth wide or 2. Pain in temples, jaw joints or jaw muscles.
Outcome measures
| Measure |
Usual Care (UC)
n=78 Participants
The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
|
Experimental Care (EC)
n=84 Participants
The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.
The 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. This device replicates the dental assistant in holding the jaw during dental procedures.
|
|---|---|---|
|
Occurrence of Pain at Follow-up With Wide Opening, or Pain in the Temple, Jaw Joint or Jaw Muscles.
Pain reported at 3 months
|
18 Participants
|
21 Participants
|
|
Occurrence of Pain at Follow-up With Wide Opening, or Pain in the Temple, Jaw Joint or Jaw Muscles.
No pain reported at 3months
|
60 Participants
|
63 Participants
|
PRIMARY outcome
Timeframe: 6 MonthThe primary outcome is the self-report of the occurrence of TMD pain post-baseline. All subjects were pain-free at baseline (i.e., pre-surgically) for TMD pain. TMD pain is deemed to have occurred if the subject's self report endorses at 1, 3 or 6 months post-baseline either or both of the following questions: 1. Pain in jaw when opening mouth wide or 2. Pain in temples, jaw joints or jaw muscles.
Outcome measures
| Measure |
Usual Care (UC)
n=80 Participants
The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
|
Experimental Care (EC)
n=83 Participants
The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.
The 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. This device replicates the dental assistant in holding the jaw during dental procedures.
|
|---|---|---|
|
Occurrence of Pain at Follow-up With Wide Opening, or Pain in the Temple, Jaw Joint or Jaw Muscles.
Pain reported at 6 months
|
16 Participants
|
21 Participants
|
|
Occurrence of Pain at Follow-up With Wide Opening, or Pain in the Temple, Jaw Joint or Jaw Muscles.
No pain reported at 6 months
|
64 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: 1 MonthThe occurrence of TMD pain post-baseline will be measured using the reliable and valid TMD Pain Screener Questionnaire. This subject self-report measure is comprised of 3 questions assessing the duration of TMD pain, presence of jaw pain or stiffness upon awakening, and activities that change TMD pain. TMD pain is deemed to have occurred if the subject's self report at 1, 3 or 6 months post-baseline is positive for the presence of TMD pain per the TMD Pain Screener.
Outcome measures
| Measure |
Usual Care (UC)
n=79 Participants
The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
|
Experimental Care (EC)
n=83 Participants
The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.
The 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. This device replicates the dental assistant in holding the jaw during dental procedures.
|
|---|---|---|
|
Occurrence of Pain Related TMD at Follow-up Using the TMD Pain Screener Questionnaire.
Pain reported at 1 month
|
17 Participants
|
18 Participants
|
|
Occurrence of Pain Related TMD at Follow-up Using the TMD Pain Screener Questionnaire.
No pain reported at 1 month
|
62 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: 3 monthsThe occurrence of TMD pain post-baseline will be measured using the reliable and valid TMD Pain Screener Questionnaire. This subject self-report measure is comprised of 3 questions assessing the duration of TMD pain, presence of jaw pain or stiffness upon awakening, and activities that change TMD pain. TMD pain is deemed to have occurred if the subject's self report at 1, 3 or 6 months post-baseline is positive for the presence of TMD pain per the TMD Pain Screener.
Outcome measures
| Measure |
Usual Care (UC)
n=78 Participants
The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
|
Experimental Care (EC)
n=82 Participants
The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.
The 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. This device replicates the dental assistant in holding the jaw during dental procedures.
|
|---|---|---|
|
Occurrence of Pain Related TMD at Follow-up Using the TMD Pain Screener Questionnaire.
Pain reported at 3 months
|
7 Participants
|
8 Participants
|
|
Occurrence of Pain Related TMD at Follow-up Using the TMD Pain Screener Questionnaire.
No pain reported at 3 months
|
71 Participants
|
74 Participants
|
SECONDARY outcome
Timeframe: 6 MonthsThe occurrence of TMD pain post-baseline will be measured using the reliable and valid TMD Pain Screener Questionnaire. This subject self-report measure is comprised of 3 questions assessing the duration of TMD pain, presence of jaw pain or stiffness upon awakening, and activities that change TMD pain. TMD pain is deemed to have occurred if the subject's self report at 1, 3 or 6 months post-baseline is positive for the presence of TMD pain per the TMD Pain Screener.
Outcome measures
| Measure |
Usual Care (UC)
n=80 Participants
The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
|
Experimental Care (EC)
n=80 Participants
The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.
The 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. This device replicates the dental assistant in holding the jaw during dental procedures.
|
|---|---|---|
|
Occurrence of Pain Related TMD at Follow-up Using the TMD Pain Screener Questionnaire.
Pain reported at 6 months
|
6 Participants
|
5 Participants
|
|
Occurrence of Pain Related TMD at Follow-up Using the TMD Pain Screener Questionnaire.
No pain reported at 6 months
|
74 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: 1 MonthSubjects will compete at 1, 3 or 6 months post-baseline the reliable and valid Characteristic Pain Index (CPI) that measures pain intensity. It is comprised of 3 items assessed using numerical rating scales (0-10): current pain, worst pain and average pain. The final score is the average of these 3 items x 10. The CPI is part of the Graded Chronic Pain Scale (GCPS).
Outcome measures
| Measure |
Usual Care (UC)
n=80 Participants
The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
|
Experimental Care (EC)
n=85 Participants
The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.
The 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. This device replicates the dental assistant in holding the jaw during dental procedures.
|
|---|---|---|
|
Intensity of Pain at Follow-up Using the Characteristic Pain Index (CPI).
|
8.2 score on a scale
Standard Error 1.8
|
10.2 score on a scale
Standard Error 1.8
|
SECONDARY outcome
Timeframe: 3 MonthsSubjects will compete at 1, 3 or 6 months post-baseline the reliable and valid Characteristic Pain Index (CPI) that measures pain intensity. It is comprised of 3 items assessed using numerical rating scales (0-10): current pain, worst pain and average pain. The final score is the average of these 3 items x 10. The CPI is part of the Graded Chronic Pain Scale (GCPS).
Outcome measures
| Measure |
Usual Care (UC)
n=78 Participants
The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
|
Experimental Care (EC)
n=84 Participants
The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.
The 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. This device replicates the dental assistant in holding the jaw during dental procedures.
|
|---|---|---|
|
Intensity of Pain at Follow-up Using the Characteristic Pain Index (CPI).
|
3.6 score on a scale
Standard Error 1.4
|
5.5 score on a scale
Standard Error 1.3
|
SECONDARY outcome
Timeframe: 6 MonthsSubjects will compete at 1, 3 or 6 months post-baseline the reliable and valid Characteristic Pain Index (CPI) that measures pain intensity. It is comprised of 3 items assessed using numerical rating scales (0-10): current pain, worst pain and average pain. The final score is the average of these 3 items x 10. The CPI is part of the Graded Chronic Pain Scale (GCPS).
Outcome measures
| Measure |
Usual Care (UC)
n=80 Participants
The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
|
Experimental Care (EC)
n=83 Participants
The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.
The 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. This device replicates the dental assistant in holding the jaw during dental procedures.
|
|---|---|---|
|
Intensity of Pain at Follow-up Using the Characteristic Pain Index (CPI).
|
2.5 score on a scale
Standard Error 1.1
|
4.9 score on a scale
Standard Error 1.0
|
SECONDARY outcome
Timeframe: 1 MonthPopulation: The flow chart numbers for the overall study indicate participants' completion as reported for the primary outcome. The numbers represented here indicate that all participants randomized into the study did not complete all of the questions to calculate this secondary outcome measure.
TMJ noise is deemed to have occurred at 1, 3 or 6 months post-baseline if the subject's self report endorses the question: Have you had any clicking or popping in your jaw joints?
Outcome measures
| Measure |
Usual Care (UC)
n=79 Participants
The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
|
Experimental Care (EC)
n=85 Participants
The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.
The 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. This device replicates the dental assistant in holding the jaw during dental procedures.
|
|---|---|---|
|
Occurrence of TMJ Noise at Follow-up Using Self Report.
No TMJ noise reported at 1 month
|
74 Participants
|
73 Participants
|
|
Occurrence of TMJ Noise at Follow-up Using Self Report.
TMJ noise reported at 1 month
|
5 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: The flow chart numbers for the overall study indicate participants' completion as reported for the primary outcome. The numbers represented here indicate that all participants randomized into the study did not complete all of the questions to calculate this secondary outcome measure.
TMJ noise is deemed to have occurred at 1, 3 or 6 months post-baseline if the subject's self report endorses the question: Have you had any clicking or popping in your jaw joints?
Outcome measures
| Measure |
Usual Care (UC)
n=77 Participants
The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
|
Experimental Care (EC)
n=82 Participants
The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.
The 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. This device replicates the dental assistant in holding the jaw during dental procedures.
|
|---|---|---|
|
Occurrence of TMJ Noise at Follow-up Using Self Report.
TMJ noise reported at 3 months
|
9 Participants
|
12 Participants
|
|
Occurrence of TMJ Noise at Follow-up Using Self Report.
No TMJ noise reported at 3 months
|
68 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: The flow chart numbers for the overall study indicate participants' completion as reported for the primary outcome. The numbers represented here indicate that all participants randomized into the study did not complete all of the questions to calculate this secondary outcome measure.
TMJ noise is deemed to have occurred at 1, 3 or 6 months post-baseline if the subject's self report endorses the question: Have you had any clicking or popping in your jaw joints?
Outcome measures
| Measure |
Usual Care (UC)
n=79 Participants
The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
|
Experimental Care (EC)
n=83 Participants
The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.
The 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. This device replicates the dental assistant in holding the jaw during dental procedures.
|
|---|---|---|
|
Occurrence of TMJ Noise at Follow-up Using Self Report.
TMJ noise reported at 6 months
|
12 Participants
|
15 Participants
|
|
Occurrence of TMJ Noise at Follow-up Using Self Report.
No TMJ noise reported at 6 months
|
67 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: 1 MonthSubjects will report any change in jaw pain at 1, 3 or 6 months post-baseline using this question: How would you describe the change (if any) in your jaw pain since it started? The response options are: Much Worse (1), Slightly Worse(2), No Change(3), Slightly Better(4) or Much Better(5).
Outcome measures
| Measure |
Usual Care (UC)
n=80 Participants
The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
|
Experimental Care (EC)
n=85 Participants
The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.
The 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. This device replicates the dental assistant in holding the jaw during dental procedures.
|
|---|---|---|
|
Change in Jaw Pain at Follow-up Using Self-report.
Change in jaw pain from baseline much better; self-report
|
19 Participants
|
16 Participants
|
|
Change in Jaw Pain at Follow-up Using Self-report.
Change in jaw pain from baseline slightly better; self-report
|
4 Participants
|
7 Participants
|
|
Change in Jaw Pain at Follow-up Using Self-report.
No change in jaw pain from baseline; self-report
|
2 Participants
|
7 Participants
|
|
Change in Jaw Pain at Follow-up Using Self-report.
Change in jaw pain from baseline slightly worse; self-report
|
0 Participants
|
1 Participants
|
|
Change in Jaw Pain at Follow-up Using Self-report.
Change in jaw pain from baseline much worse; self-report
|
1 Participants
|
1 Participants
|
|
Change in Jaw Pain at Follow-up Using Self-report.
No jaw pain reported
|
54 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: 3 MonthsSubjects will report any change in jaw pain at 1, 3 or 6 months post-baseline using this question: How would you describe the change (if any) in your jaw pain since it started? The response options are: Much Worse (1), Slightly Worse(2), No Change(3), Slightly Better(4) or Much Better(5).
Outcome measures
| Measure |
Usual Care (UC)
n=77 Participants
The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
|
Experimental Care (EC)
n=84 Participants
The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.
The 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. This device replicates the dental assistant in holding the jaw during dental procedures.
|
|---|---|---|
|
Change in Jaw Pain at Follow-up Using Self-report.
Change in jaw pain from baseline much better; self-report
|
8 Participants
|
9 Participants
|
|
Change in Jaw Pain at Follow-up Using Self-report.
Change in jaw pain from baseline slightly better; self-report
|
3 Participants
|
4 Participants
|
|
Change in Jaw Pain at Follow-up Using Self-report.
No change in jaw pain from baseline; self-report
|
5 Participants
|
5 Participants
|
|
Change in Jaw Pain at Follow-up Using Self-report.
Change in jaw pain from baseline slightly worse; self-report
|
1 Participants
|
2 Participants
|
|
Change in Jaw Pain at Follow-up Using Self-report.
Change in jaw pain from baseline much worse; self-report
|
0 Participants
|
1 Participants
|
|
Change in Jaw Pain at Follow-up Using Self-report.
No pain reported
|
60 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: 6 MonthsSubjects will report any change in jaw pain at 1, 3 or 6 months post-baseline using this question: How would you describe the change (if any) in your jaw pain since it started? The response options are: Much Worse (1), Slightly Worse(2), No Change(3), Slightly Better(4) or Much Better(5).
Outcome measures
| Measure |
Usual Care (UC)
n=80 Participants
The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
|
Experimental Care (EC)
n=83 Participants
The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block.
The 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. This device replicates the dental assistant in holding the jaw during dental procedures.
|
|---|---|---|
|
Change in Jaw Pain at Follow-up Using Self-report.
Change in jaw pain from baseline much better; self-report
|
7 Participants
|
8 Participants
|
|
Change in Jaw Pain at Follow-up Using Self-report.
Change in jaw pain from baseline slightly better; self-report
|
0 Participants
|
4 Participants
|
|
Change in Jaw Pain at Follow-up Using Self-report.
No change in jaw pain from baseline; self-report
|
8 Participants
|
8 Participants
|
|
Change in Jaw Pain at Follow-up Using Self-report.
Change in jaw pain from baseline slightly worse; self-report
|
1 Participants
|
1 Participants
|
|
Change in Jaw Pain at Follow-up Using Self-report.
Change in jaw pain from baseline much worse; self-report
|
0 Participants
|
0 Participants
|
|
Change in Jaw Pain at Follow-up Using Self-report.
No pain reported
|
64 Participants
|
62 Participants
|
Adverse Events
Usual Care (UC)
Experimental Care (EC)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place