Trial Outcomes & Findings for Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles (NCT NCT03223298)
NCT ID: NCT03223298
Last Updated: 2023-02-14
Results Overview
Visual Analog Scale ranging from "no pain (0)" to "pain as bad as it could possibly be (100)"
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
75 participants
Primary outcome timeframe
Pre-intervention, Change at 1 month post-intervention, Change at 2 months post-intervention, Change at 3 months post-intervention
Results posted on
2023-02-14
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin Type A
The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive 100 units of reconstituted botulinum toxin A. 37.5 units will be injected into each masseter muscle and 12.5 units into each temporalis muscle. A written post-operative instruction sheet will be provided to all patients.
Botulinum toxin type A: 37.5 units injected into each masseter muscle and 12.5 units into each temporalis muscle
|
0.9% Sodium Chloride Injection
The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive unpreserved 0.9% sodium chloride. A written post-operative instruction sheet will be provided to all patients.
0.9% Sodium Chloride Injection: 1cc syringe
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
37
|
|
Overall Study
Pre-op
|
38
|
37
|
|
Overall Study
Month 1 Post-op
|
34
|
32
|
|
Overall Study
Month 2 Post-op
|
22
|
28
|
|
Overall Study
Month 3 Post-op
|
23
|
27
|
|
Overall Study
COMPLETED
|
23
|
27
|
|
Overall Study
NOT COMPLETED
|
15
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles
Baseline characteristics by cohort
| Measure |
Botulinum Toxin Type A
n=38 Participants
The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive 100 units of reconstituted botulinum toxin A. 37.5 units will be injected into each masseter muscle and 12.5 units into each temporalis muscle. A written post-operative instruction sheet will be provided to all patients.
Botulinum toxin type A: 37.5 units injected into each masseter muscle and 12.5 units into each temporalis muscle
|
0.9% Sodium Chloride Injection
n=37 Participants
The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive unpreserved 0.9% sodium chloride. A written post-operative instruction sheet will be provided to all patients.
0.9% Sodium Chloride Injection: 1cc syringe
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian / Pacific Islander
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-intervention, Change at 1 month post-intervention, Change at 2 months post-intervention, Change at 3 months post-interventionPopulation: Patient retention varied per time point
Visual Analog Scale ranging from "no pain (0)" to "pain as bad as it could possibly be (100)"
Outcome measures
| Measure |
Botulinum Toxin Type A
n=38 Participants
The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive 100 units of reconstituted botulinum toxin A. 37.5 units will be injected into each masseter muscle and 12.5 units into each temporalis muscle. A written post-operative instruction sheet will be provided to all patients.
Botulinum toxin type A: 37.5 units injected into each masseter muscle and 12.5 units into each temporalis muscle
|
0.9% Sodium Chloride Injection
n=37 Participants
The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive unpreserved 0.9% sodium chloride. A written post-operative instruction sheet will be provided to all patients.
0.9% Sodium Chloride Injection: 1cc syringe
|
|---|---|---|
|
Change in Jaw Pain as Reported by Patient on Visual Analog Scale (VAS)
Pre-intervention
|
58 score on a scale
Standard Deviation 15
|
54 score on a scale
Standard Deviation 14
|
|
Change in Jaw Pain as Reported by Patient on Visual Analog Scale (VAS)
Change at 1 months post-intervention
|
-19 score on a scale
Standard Deviation 24
|
-14 score on a scale
Standard Deviation 23
|
|
Change in Jaw Pain as Reported by Patient on Visual Analog Scale (VAS)
Change at 2 months post-intervention
|
-18 score on a scale
Standard Deviation 24
|
-18 score on a scale
Standard Deviation 23
|
|
Change in Jaw Pain as Reported by Patient on Visual Analog Scale (VAS)
Change at 3 months post-intervention
|
-17 score on a scale
Standard Deviation 22
|
-16 score on a scale
Standard Deviation 23
|
SECONDARY outcome
Timeframe: Pre-intervention, 1 month post-intervention, 2 months post-intervention, 3 months post-interventionPopulation: Patient retention varied per time point
A series of yes or no questions to determine what activities a patient's jaw problem prevents or limits them from doing. A high score of 7 indicates severe jaw limitation, a low score of 0 indicates no jaw limitation.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=38 Participants
The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive 100 units of reconstituted botulinum toxin A. 37.5 units will be injected into each masseter muscle and 12.5 units into each temporalis muscle. A written post-operative instruction sheet will be provided to all patients.
Botulinum toxin type A: 37.5 units injected into each masseter muscle and 12.5 units into each temporalis muscle
|
0.9% Sodium Chloride Injection
n=37 Participants
The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive unpreserved 0.9% sodium chloride. A written post-operative instruction sheet will be provided to all patients.
0.9% Sodium Chloride Injection: 1cc syringe
|
|---|---|---|
|
Jaw Function as Measured by Jaw Function Limitation Scale
Pre-intervention
|
0.38 score on a scale
Interval 0.25 to 0.63
|
0.38 score on a scale
Interval 0.25 to 0.5
|
|
Jaw Function as Measured by Jaw Function Limitation Scale
1 month post-intervention
|
0.38 score on a scale
Interval 0.13 to 0.38
|
0.25 score on a scale
Interval 0.13 to 0.38
|
|
Jaw Function as Measured by Jaw Function Limitation Scale
2 months post-intervention
|
0.25 score on a scale
Interval 0.25 to 0.5
|
0.25 score on a scale
Interval 0.13 to 0.38
|
|
Jaw Function as Measured by Jaw Function Limitation Scale
3 months post-intervention
|
0.25 score on a scale
Interval 0.13 to 0.44
|
0.25 score on a scale
Interval 0.06 to 0.38
|
SECONDARY outcome
Timeframe: Pre-intervention, Change at 1 month post-intervention, Change at 2 months post-intervention, Change at 3 months post-interventionPopulation: Patient retention varied per time point
Mouth opening measurements in mm both when patient is in pain and not in pain. This measurement is taken from the maxillary central incisor to mandibular central incisor.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=38 Participants
The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive 100 units of reconstituted botulinum toxin A. 37.5 units will be injected into each masseter muscle and 12.5 units into each temporalis muscle. A written post-operative instruction sheet will be provided to all patients.
Botulinum toxin type A: 37.5 units injected into each masseter muscle and 12.5 units into each temporalis muscle
|
0.9% Sodium Chloride Injection
n=37 Participants
The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive unpreserved 0.9% sodium chloride. A written post-operative instruction sheet will be provided to all patients.
0.9% Sodium Chloride Injection: 1cc syringe
|
|---|---|---|
|
Change in Jaw Function as Measured by Maximum Interincisal Opening (MIO)
MIO with Pain: Pre-intervention
|
41 mm
Standard Deviation 7
|
42 mm
Standard Deviation 8
|
|
Change in Jaw Function as Measured by Maximum Interincisal Opening (MIO)
MIO without Pain: Pre-Intervention
|
34 mm
Standard Deviation 7
|
34 mm
Standard Deviation 10
|
|
Change in Jaw Function as Measured by Maximum Interincisal Opening (MIO)
Change in MIO with Pain at 1-month post-intervention
|
0 mm
Standard Deviation 5
|
2 mm
Standard Deviation 6
|
|
Change in Jaw Function as Measured by Maximum Interincisal Opening (MIO)
Change in MIO without Pain at 1-month post-intervention
|
1 mm
Standard Deviation 6
|
4 mm
Standard Deviation 8
|
|
Change in Jaw Function as Measured by Maximum Interincisal Opening (MIO)
Change in MIO with Pain at 2-months post-intervention
|
-1 mm
Standard Deviation 7
|
1 mm
Standard Deviation 7
|
|
Change in Jaw Function as Measured by Maximum Interincisal Opening (MIO)
Change in MIO without Pain at 2-months post-intervention
|
-1 mm
Standard Deviation 8
|
3 mm
Standard Deviation 8
|
|
Change in Jaw Function as Measured by Maximum Interincisal Opening (MIO)
Change in MIO with Pain at 3-months post-intervention
|
-1 mm
Standard Deviation 5
|
1 mm
Standard Deviation 8
|
|
Change in Jaw Function as Measured by Maximum Interincisal Opening (MIO)
Change in MIO without Pain at 3-months post-intervention
|
2 mm
Standard Deviation 8
|
4 mm
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Pre-intervention, Change at 1 month post-intervention, Change at 2 months post-intervention, Change at 3 months post-interventionPopulation: Patient retention varied per time point
Short Form 36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are utilized for routine monitoring and assessment of care outcomes in adult patients. A high score of 100 on this survey indicates the patient is self-reporting a high quality-of-life, a low score of 0 indicates a low quality-of-life.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=38 Participants
The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive 100 units of reconstituted botulinum toxin A. 37.5 units will be injected into each masseter muscle and 12.5 units into each temporalis muscle. A written post-operative instruction sheet will be provided to all patients.
Botulinum toxin type A: 37.5 units injected into each masseter muscle and 12.5 units into each temporalis muscle
|
0.9% Sodium Chloride Injection
n=37 Participants
The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive unpreserved 0.9% sodium chloride. A written post-operative instruction sheet will be provided to all patients.
0.9% Sodium Chloride Injection: 1cc syringe
|
|---|---|---|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 3 months post intervention - Social Functioning Score
|
0 score on a scale
Interval -25.0 to 12.0
|
0 score on a scale
Interval -12.0 to 12.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Pre-intervention - Pain Score
|
78 score on a scale
Interval 58.0 to 90.0
|
58 score on a scale
Interval 55.0 to 78.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 1 month post intervention - Pain Score
|
0 score on a scale
Interval -2.0 to 12.0
|
10 score on a scale
Interval 0.0 to 25.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 2 months post intervention - Pain Score
|
0 score on a scale
Interval -10.0 to 18.0
|
11 score on a scale
Interval 0.0 to 22.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 3 months post intervention - Pain Score
|
0 score on a scale
Interval -5.0 to 18.0
|
10 score on a scale
Interval -6.0 to 32.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Pre-intervention - General Health Score
|
75 score on a scale
Interval 60.0 to 85.0
|
70 score on a scale
Interval 55.0 to 85.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 1 month post intervention - General Health Score
|
0 score on a scale
Interval -5.0 to 10.0
|
0 score on a scale
Interval -1.0 to 10.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 2 months post intervention - General Health Score
|
2 score on a scale
Interval 0.0 to 10.0
|
5 score on a scale
Interval -5.0 to 6.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 3 months post intervention - General Health Score
|
0 score on a scale
Interval -5.0 to 5.0
|
5 score on a scale
Interval -5.0 to 10.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Pre-intervention - Physical Functioning Score
|
100 score on a scale
Interval 95.0 to 100.0
|
100 score on a scale
Interval 90.0 to 100.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 1 month post intervention - Physical Functioning Score
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 2 months post-intervention - Physical Functioning Score
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 5.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 3 months post-intervention - Physical Functioning Score
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 2.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Pre-intervention - Role Limitations - Physical Health Score
|
100 score on a scale
Interval 75.0 to 100.0
|
100 score on a scale
Interval 50.0 to 100.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 1 month post intervention - Role Limitations - Physical Health Score
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 2 months post intervention - Role Limitations- Physical Health Score
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 3 months post intervention - Role Limitations - Physical Health Score
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 25.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Pre-intervention - Role Limitations - Emotional Score
|
100 score on a scale
Interval 67.0 to 100.0
|
100 score on a scale
Interval 33.0 to 100.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 1 month post intervention - Role Limitations - Emotional Score
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 33.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 2 months post intervention - Role Limitations - Emotional Score
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 33.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 3 months post intervention - Role Limitations - Emotional Score
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval -33.0 to 33.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Pre-intervention - Energy/Fatigue Score
|
50 score on a scale
Interval 45.0 to 70.0
|
60 score on a scale
Interval 35.0 to 65.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 1 month post intervention - Energy/Fatigue Score
|
5 score on a scale
Interval -4.0 to 10.0
|
0 score on a scale
Interval -5.0 to 11.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 2 months post intervention - Energy/Fatigue Score
|
2 score on a scale
Interval -4.0 to 15.0
|
5 score on a scale
Interval -5.0 to 11.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 3 months post intervention - Energy/Fatigue Score
|
5 score on a scale
Interval -2.0 to 10.0
|
0 score on a scale
Interval -5.0 to 15.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Pre-intervention - Emotional Well-Being Score
|
76 score on a scale
Interval 64.0 to 84.0
|
68 score on a scale
Interval 52.0 to 84.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 1 month post intervention - Emotional Well-Being Score
|
2 score on a scale
Interval 0.0 to 8.0
|
4 score on a scale
Interval -4.0 to 13.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 2 months post intervention - Emotional Well-Being Score
|
4 score on a scale
Interval 0.0 to 8.0
|
8 score on a scale
Interval -1.0 to 13.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 3 months post intervention - Emotional Well-Being Score
|
4 score on a scale
Interval -6.0 to 6.0
|
4 score on a scale
Interval 0.0 to 14.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Pre-intervention - Social Functioning Score
|
100 score on a scale
Interval 75.0 to 100.0
|
88 score on a scale
Interval 50.0 to 100.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 1 month post intervention - Social Functioning Score
|
0 score on a scale
Interval -12.0 to 12.0
|
0 score on a scale
Interval -3.0 to 12.0
|
|
Change in Objectively Assessed Quality of Life as Measured by Short Form 36
Change at 2 months post intervention - Social Functioning Score
|
0 score on a scale
Interval 0.0 to 12.0
|
0 score on a scale
Interval 0.0 to 16.0
|
Adverse Events
Botulinum Toxin Type A
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
0.9% Sodium Chloride Injection
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Botulinum Toxin Type A
n=38 participants at risk
The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive 100 units of reconstituted botulinum toxin A. 37.5 units will be injected into each masseter muscle and 12.5 units into each temporalis muscle. A written post-operative instruction sheet will be provided to all patients.
Botulinum toxin type A: 37.5 units injected into each masseter muscle and 12.5 units into each temporalis muscle
|
0.9% Sodium Chloride Injection
n=37 participants at risk
The intramuscular injections will be performed with the patient awake in the oral and maxillofacial surgery clinic. Three injection sites into bilateral masseter muscles and two injection sites into bilateral temporalis muscles will be identified by having the patient clench. The sites will be marked with a surgical pen prior to injections. The skin at the injection sites will be cleaned with an alcohol swab. Via a 1cc TB syringe and a 30-gauge needle, the subject will then receive unpreserved 0.9% sodium chloride. A written post-operative instruction sheet will be provided to all patients.
0.9% Sodium Chloride Injection: 1cc syringe
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Increase in pain
|
10.5%
4/38 • Number of events 4 • 90 days
|
2.7%
1/37 • Number of events 1 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Headaches
|
2.6%
1/38 • Number of events 1 • 90 days
|
0.00%
0/37 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Mild weakness
|
2.6%
1/38 • Number of events 1 • 90 days
|
0.00%
0/37 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Masseter tenderness
|
0.00%
0/38 • 90 days
|
2.7%
1/37 • Number of events 1 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Ecchymosis
|
0.00%
0/38 • 90 days
|
2.7%
1/37 • Number of events 1 • 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place