Trial Outcomes & Findings for Comparison of Dry Needling and Two Botulinum Toxins for Bruxism (NCT NCT07452510)
NCT ID: NCT07452510
Last Updated: 2026-05-20
Results Overview
Self-reported pain intensity on a scale from 0 (no pain) to 10 (worst imaginable pain). Measurements were taken at baseline, 1 month, and 3 months post-treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
Baseline, 1 month, and 3 months.
Results posted on
2026-05-20
Participant Flow
The study was conducted on patients who applied to the Department of Oral and Maxillofacial Surgery at Recep Tayyip Erdogan University Faculty of Dentistry in 2026. Participants were diagnosed with bruxism based on clinical examinations and medical history. A total of 72 patients who met the inclusion criteria were initially enrolled.
Participant milestones
| Measure |
Dry Needling Group
Patients in this group received deep dry needling treatment. The procedure was performed once a week for a total of three sessions. Sterile needles (0.25x25 mm) were applied to myofascial trigger points in the masseter and anterior temporal muscles.
|
PraBotulinumtoxinA
Patients received a single-session injection of 50 Units (U) of PrabotulinumtoxinA. The total dose was distributed bilaterally as 15U for each masseter muscle (at 3 points) and 10U for each anterior temporal muscle (at 2 points).
|
AbobotulinumtoxinA
Patients received a single-session injection of approximately 167 Units (U) of AbobotulinumtoxinA. The total dose was distributed bilaterally as 50U for each masseter muscle (at 3 points) and approximately 33U for each anterior temporal muscle (at 2 points).
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
24
|
|
Overall Study
COMPLETED
|
22
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Dry Needling Group
Patients in this group received deep dry needling treatment. The procedure was performed once a week for a total of three sessions. Sterile needles (0.25x25 mm) were applied to myofascial trigger points in the masseter and anterior temporal muscles.
|
PraBotulinumtoxinA
Patients received a single-session injection of 50 Units (U) of PrabotulinumtoxinA. The total dose was distributed bilaterally as 15U for each masseter muscle (at 3 points) and 10U for each anterior temporal muscle (at 2 points).
|
AbobotulinumtoxinA
Patients received a single-session injection of approximately 167 Units (U) of AbobotulinumtoxinA. The total dose was distributed bilaterally as 50U for each masseter muscle (at 3 points) and approximately 33U for each anterior temporal muscle (at 2 points).
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
Baseline characteristics by cohort
| Measure |
Dry Needling Group
n=22 Participants
Patients in this group received deep dry needling treatment. The procedure was performed once a week for a total of three sessions. Sterile needles (0.25x25 mm) were applied to myofascial trigger points in the masseter and anterior temporal muscles.
|
PraBotulinumtoxinA
n=23 Participants
Patients received a single-session injection of 50 Units (U) of PrabotulinumtoxinA. The total dose was distributed bilaterally as 15U for each masseter muscle (at 3 points) and 10U for each anterior temporal muscle (at 2 points).
|
AbobotulinumtoxinA
n=24 Participants
Patients received a single-session injection of approximately 167 Units (U) of AbobotulinumtoxinA. The total dose was distributed bilaterally as 50U for each masseter muscle (at 3 points) and approximately 33U for each anterior temporal muscle (at 2 points).
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=22 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
0 Participants
n=23 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
0 Participants
n=24 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
0 Participants
n=69 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=22 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
23 Participants
n=23 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
24 Participants
n=24 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
69 Participants
n=69 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
|
Baseline Muscle Thickness
Right masseter relaxed
|
0.742 cm
STANDARD_DEVIATION 0.134 • n=22 Participants
|
0.875 cm
STANDARD_DEVIATION 0.264 • n=23 Participants
|
0.881 cm
STANDARD_DEVIATION 0.190 • n=24 Participants
|
0.835 cm
STANDARD_DEVIATION 0.211 • n=69 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=22 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
0 Participants
n=23 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
0 Participants
n=24 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
0 Participants
n=69 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
|
Sex: Female, Male
Female
|
19 Participants
n=22 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
20 Participants
n=23 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
22 Participants
n=24 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
61 Participants
n=69 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
|
Sex: Female, Male
Male
|
3 Participants
n=22 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
3 Participants
n=23 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
2 Participants
n=24 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
8 Participants
n=69 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
22 Participants
n=22 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
23 Participants
n=23 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
24 Participants
n=24 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
69 Participants
n=69 Participants • Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
|
|
VAS score at baseline
|
8.909 scores on a scale
STANDARD_DEVIATION 0.426 • n=22 Participants
|
8.957 scores on a scale
STANDARD_DEVIATION 0.367 • n=23 Participants
|
9.167 scores on a scale
STANDARD_DEVIATION 0.565 • n=24 Participants
|
9.015 scores on a scale
STANDARD_DEVIATION 0.468 • n=69 Participants
|
|
Baseline Muscle Thickness
Left masseter relaxed
|
0.735 cm
STANDARD_DEVIATION 0.168 • n=22 Participants
|
0.841 cm
STANDARD_DEVIATION 0.215 • n=23 Participants
|
0.852 cm
STANDARD_DEVIATION 0.182 • n=24 Participants
|
0.811 cm
STANDARD_DEVIATION 0.194 • n=69 Participants
|
|
Baseline Muscle Thickness
Left masseter contracted
|
1.195 cm
STANDARD_DEVIATION 0.190 • n=22 Participants
|
1.308 cm
STANDARD_DEVIATION 0.273 • n=23 Participants
|
1.37 cm
STANDARD_DEVIATION 0.214 • n=24 Participants
|
1.294 cm
STANDARD_DEVIATION 0.237 • n=69 Participants
|
|
Baseline Muscle Thickness
Left temporalis relaxed
|
0.343 cm
STANDARD_DEVIATION 0.101 • n=22 Participants
|
0.381 cm
STANDARD_DEVIATION 0.108 • n=23 Participants
|
0.396 cm
STANDARD_DEVIATION 0.091 • n=24 Participants
|
0.374 cm
STANDARD_DEVIATION 0.102 • n=69 Participants
|
|
Baseline Muscle Thickness
Left temporalis contracted
|
0.481 cm
STANDARD_DEVIATION 0.146 • n=22 Participants
|
0.562 cm
STANDARD_DEVIATION 0.139 • n=23 Participants
|
0.540 cm
STANDARD_DEVIATION 0.105 • n=24 Participants
|
0.529 cm
STANDARD_DEVIATION 0.133 • n=69 Participants
|
|
Baseline Muscle Thickness
Right masseter contracted
|
1.227 cm
STANDARD_DEVIATION 0.145 • n=22 Participants
|
1.261 cm
STANDARD_DEVIATION 0.333 • n=23 Participants
|
1.369 cm
STANDARD_DEVIATION 0.219 • n=24 Participants
|
1.288 cm
STANDARD_DEVIATION 0.250 • n=69 Participants
|
|
Baseline Muscle Thickness
Right temporalis relaxed
|
0.359 cm
STANDARD_DEVIATION 0.096 • n=22 Participants
|
0.433 cm
STANDARD_DEVIATION 0.107 • n=23 Participants
|
0.374 cm
STANDARD_DEVIATION 0.064 • n=24 Participants
|
0.389 cm
STANDARD_DEVIATION 0.095 • n=69 Participants
|
|
Baseline Muscle Thickness
Right temporalis contracted
|
0.485 cm
STANDARD_DEVIATION 0.139 • n=22 Participants
|
0.592 cm
STANDARD_DEVIATION 0.138 • n=23 Participants
|
0.550 cm
STANDARD_DEVIATION 0.103 • n=24 Participants
|
0.543 cm
STANDARD_DEVIATION 0.133 • n=69 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 month, and 3 months.Self-reported pain intensity on a scale from 0 (no pain) to 10 (worst imaginable pain). Measurements were taken at baseline, 1 month, and 3 months post-treatment.
Outcome measures
| Measure |
Dry Needling Group
n=22 Participants
Patients in this group received deep dry needling treatment. The procedure was performed once a week for a total of three sessions. Sterile needles (0.25x25 mm) were applied to myofascial trigger points in the masseter and anterior temporal muscles.
|
PraBotulinumtoxinA
n=23 Participants
Patients received a single-session injection of 50 Units (U) of PrabotulinumtoxinA. The total dose was distributed bilaterally as 15U for each masseter muscle (at 3 points) and 10U for each anterior temporal muscle (at 2 points).
|
AbobotulinumtoxinA
n=24 Participants
Patients received a single-session injection of approximately 167 Units (U) of AbobotulinumtoxinA. The total dose was distributed bilaterally as 75U for each masseter muscle (at 3 points) and approximately 33U for each anterior temporal muscle (at 2 points).
|
|---|---|---|---|
|
Pain Intensity Measured by Visual Analog Scale (VAS)
VAS score at 1 month
|
1.591 VAS score (0-10)
Standard Deviation 0.734
|
0.957 VAS score (0-10)
Standard Deviation 0.638
|
0.417 VAS score (0-10)
Standard Deviation 0.584
|
|
Pain Intensity Measured by Visual Analog Scale (VAS)
VAS score at 3 month
|
5.182 VAS score (0-10)
Standard Deviation 1.402
|
2.348 VAS score (0-10)
Standard Deviation 1.301
|
2.417 VAS score (0-10)
Standard Deviation 1.139
|
|
Pain Intensity Measured by Visual Analog Scale (VAS)
VAS score at 0 month
|
8.909 VAS score (0-10)
Standard Deviation 0.426
|
8.957 VAS score (0-10)
Standard Deviation 0.367
|
9.167 VAS score (0-10)
Standard Deviation 0.565
|
PRIMARY outcome
Timeframe: 3rd month post-treatment.Measurement of the thickness of the masseter and anterior temporal muscles in millimeters (cm) using a high-frequency linear probe. Measurements are taken bilaterally both at rest and during maximum voluntary contraction (clenching).
Outcome measures
| Measure |
Dry Needling Group
n=22 Participants
Patients in this group received deep dry needling treatment. The procedure was performed once a week for a total of three sessions. Sterile needles (0.25x25 mm) were applied to myofascial trigger points in the masseter and anterior temporal muscles.
|
PraBotulinumtoxinA
n=23 Participants
Patients received a single-session injection of 50 Units (U) of PrabotulinumtoxinA. The total dose was distributed bilaterally as 15U for each masseter muscle (at 3 points) and 10U for each anterior temporal muscle (at 2 points).
|
AbobotulinumtoxinA
n=24 Participants
Patients received a single-session injection of approximately 167 Units (U) of AbobotulinumtoxinA. The total dose was distributed bilaterally as 75U for each masseter muscle (at 3 points) and approximately 33U for each anterior temporal muscle (at 2 points).
|
|---|---|---|---|
|
Masseter and Anterior Temporal Muscle Thickness Via Ultrasonography (USG)
Right temporalis contracted
|
0,475 cm
Standard Deviation 0,147
|
0,423 cm
Standard Deviation 0,096
|
0,385 cm
Standard Deviation 0,070
|
|
Masseter and Anterior Temporal Muscle Thickness Via Ultrasonography (USG)
left masseter relaxed
|
0,770 cm
Standard Deviation 0,186
|
0,732 cm
Standard Deviation 0,234
|
0,702 cm
Standard Deviation 0,173
|
|
Masseter and Anterior Temporal Muscle Thickness Via Ultrasonography (USG)
left masseter contracted
|
1,192 cm
Standard Deviation 0,212
|
1,101 cm
Standard Deviation 0,209
|
0,996 cm
Standard Deviation 0,155
|
|
Masseter and Anterior Temporal Muscle Thickness Via Ultrasonography (USG)
Left temporalis relaxed
|
0,359 cm
Standard Deviation 0,092
|
0,303 cm
Standard Deviation 0,079
|
0,297 cm
Standard Deviation 0,052
|
|
Masseter and Anterior Temporal Muscle Thickness Via Ultrasonography (USG)
Left temporalis contracted
|
0,489 cm
Standard Deviation 0,136
|
0,421 cm
Standard Deviation 0,113
|
0,394 cm
Standard Deviation 0,070
|
|
Masseter and Anterior Temporal Muscle Thickness Via Ultrasonography (USG)
Right masseter relaxed
|
0,750 cm
Standard Deviation 0,133
|
0,736 cm
Standard Deviation 0,205
|
0,717 cm
Standard Deviation 0,124
|
|
Masseter and Anterior Temporal Muscle Thickness Via Ultrasonography (USG)
Right masseter contracted
|
1,186 cm
Standard Deviation 0,162
|
1.06 cm
Standard Deviation 0,271
|
1.02 cm
Standard Deviation 0,141
|
|
Masseter and Anterior Temporal Muscle Thickness Via Ultrasonography (USG)
Right temporalis relaxed
|
0,358 cm
Standard Deviation 0,101
|
0,314 cm
Standard Deviation 0,074
|
0,289 cm
Standard Deviation 0,050
|
Adverse Events
Dry Needling Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PraBotulinumtoxinA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AbobotulinumtoxinA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Assoc. Prof. Emre Balaban
Recep Tayyip Erdogan University
Phone: +905053930478
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place