Trial Outcomes & Findings for Short-Term Symptom Changes in Adults With Teeth Clenching or Grinding and Jaw Symptoms Receiving Splint, Botulinum Toxin, or Medication Plus Splint Care (NCT NCT07586072)
NCT ID: NCT07586072
Last Updated: 2026-07-30
Results Overview
Change in total Fonseca Anamnestic Index score from baseline to the 3-month follow-up. The Fonseca Anamnestic Index is a 10-item symptom-based questionnaire used to assess temporomandibular disorder-related symptom severity. Total scores range from 0 to 100, with higher scores indicating more severe symptoms. The change score was calculated as pre-treatment total score minus post-treatment total score; therefore, higher positive change values indicate greater symptom improvement.
COMPLETED
60 participants
Baseline to 3 months
2026-07-30
Participant Flow
A total of 60 adult patients with bruxism-related temporomandibular disorder symptoms were enrolled at the Department of Prosthodontics, Faculty of Dentistry, Recep Tayyip Erdoğan University, Rize, Türkiye. Participants were assigned to one of three treatment arms.
No participants were excluded after enrollment. All enrolled participants were assigned to a treatment arm and included in the final analysis.
Participant milestones
| Measure |
Botulinum Toxin Type A Injection
Participants received a single session of intramuscular botulinum toxin type A injections into the masseter and temporalis muscles.
|
Occlusal Splint Therapy
Participants received custom-made maxillary stabilization splints and were instructed to wear them during sleep throughout the follow-up period.
|
Combined Medical-Splint Therapy
Participants received a custom-made maxillary stabilization splint and short-term pharmacological therapy with thiocolchicoside and tenoxicam for acute symptom control.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Occlusal Splint Therapy
n=20 Participants
Participants received custom-made maxillary stabilization splints and were instructed to wear them during sleep throughout the follow-up period.
|
Botulinum Toxin Type A Injection
n=20 Participants
Participants received a single session of intramuscular botulinum toxin type A injections into the masseter and temporalis muscles.
|
Combined Medical-Splint Therapy
n=20 Participants
Participants received a custom-made maxillary stabilization splint and short-term pharmacological therapy with thiocolchicoside and tenoxicam for acute symptom control.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
25.10 Years
STANDARD_DEVIATION 6.09 • n=20 Participants
|
25.25 Years
STANDARD_DEVIATION 6.72 • n=20 Participants
|
29.00 Years
STANDARD_DEVIATION 7.36 • n=20 Participants
|
26.45 Years
STANDARD_DEVIATION 6.87 • n=60 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
51 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
9 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Baseline Total Fonseca Anamnestic Index Score
|
62.75 points on a scale
STANDARD_DEVIATION 18.39 • n=20 Participants • The Fonseca Anamnestic Index is a 10-item symptom-based questionnaire used to assess temporomandibular disorder-related symptom severity. Total scores range from 0 to 100, with higher scores indicating more severe symptoms.
|
59.25 points on a scale
STANDARD_DEVIATION 18.73 • n=20 Participants • The Fonseca Anamnestic Index is a 10-item symptom-based questionnaire used to assess temporomandibular disorder-related symptom severity. Total scores range from 0 to 100, with higher scores indicating more severe symptoms.
|
70.00 points on a scale
STANDARD_DEVIATION 16.86 • n=20 Participants • The Fonseca Anamnestic Index is a 10-item symptom-based questionnaire used to assess temporomandibular disorder-related symptom severity. Total scores range from 0 to 100, with higher scores indicating more severe symptoms.
|
64.00 points on a scale
STANDARD_DEVIATION 18.39 • n=60 Participants • The Fonseca Anamnestic Index is a 10-item symptom-based questionnaire used to assess temporomandibular disorder-related symptom severity. Total scores range from 0 to 100, with higher scores indicating more severe symptoms.
|
PRIMARY outcome
Timeframe: Baseline to 3 monthsPopulation: All participants with baseline and 3-month follow-up Fonseca Anamnestic Index data were included in the analysis.
Change in total Fonseca Anamnestic Index score from baseline to the 3-month follow-up. The Fonseca Anamnestic Index is a 10-item symptom-based questionnaire used to assess temporomandibular disorder-related symptom severity. Total scores range from 0 to 100, with higher scores indicating more severe symptoms. The change score was calculated as pre-treatment total score minus post-treatment total score; therefore, higher positive change values indicate greater symptom improvement.
Outcome measures
| Measure |
Occlusal Splint Therapy
n=20 Participants
Participants received custom-made maxillary stabilization splints and were instructed to wear them during sleep throughout the follow-up period.
|
Botulinum Toxin Type A Injection
n=20 Participants
Participants received a single session of intramuscular botulinum toxin type A injections into the masseter and temporalis muscles.
|
Combined Medical-Splint Therapy
n=20 Participants
Participants received a custom-made maxillary stabilization splint and short-term pharmacological therapy with thiocolchicoside and tenoxicam for acute symptom control.
|
|---|---|---|---|
|
Change in Total Fonseca Anamnestic Index Score
|
33.75 points on a scale
Standard Deviation 13.85
|
27.25 points on a scale
Standard Deviation 12.62
|
39.25 points on a scale
Standard Deviation 11.04
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsPopulation: All participants with baseline and 3-month follow-up selected Fonseca Anamnestic Index sub-item data were included in the analysis.
Selected Fonseca Anamnestic Index sub-item scores were assessed at baseline and at the 3-month follow-up. Each selected item is scored from 0 to 10, with higher scores indicating more severe symptoms. The selected items assessed mouth opening difficulty, masticatory muscle fatigue or pain during chewing, temporomandibular joint clicking, and teeth clenching or grinding habit.
Outcome measures
| Measure |
Occlusal Splint Therapy
n=20 Participants
Participants received custom-made maxillary stabilization splints and were instructed to wear them during sleep throughout the follow-up period.
|
Botulinum Toxin Type A Injection
n=20 Participants
Participants received a single session of intramuscular botulinum toxin type A injections into the masseter and temporalis muscles.
|
Combined Medical-Splint Therapy
n=20 Participants
Participants received a custom-made maxillary stabilization splint and short-term pharmacological therapy with thiocolchicoside and tenoxicam for acute symptom control.
|
|---|---|---|---|
|
Selected Fonseca Anamnestic Index Sub-Item Scores at Baseline and 3 Months
Q3 - Fatigue or Muscle Pain During Chewing, 3 Months
|
2.75 points on a scale
Standard Deviation 3.02
|
2.75 points on a scale
Standard Deviation 3.02
|
1.75 points on a scale
Standard Deviation 2.45
|
|
Selected Fonseca Anamnestic Index Sub-Item Scores at Baseline and 3 Months
Q8 - Clenching or Grinding Habit, 3 Months
|
5.25 points on a scale
Standard Deviation 4.72
|
3.25 points on a scale
Standard Deviation 2.94
|
2.75 points on a scale
Standard Deviation 3.02
|
|
Selected Fonseca Anamnestic Index Sub-Item Scores at Baseline and 3 Months
Q1 - Difficulty Opening the Mouth Wide, Baseline
|
6.50 points on a scale
Standard Deviation 2.86
|
5.25 points on a scale
Standard Deviation 2.55
|
6.75 points on a scale
Standard Deviation 2.94
|
|
Selected Fonseca Anamnestic Index Sub-Item Scores at Baseline and 3 Months
Q1 - Difficulty Opening the Mouth Wide, 3 Months
|
2.50 points on a scale
Standard Deviation 2.56
|
4.25 points on a scale
Standard Deviation 2.45
|
2.50 points on a scale
Standard Deviation 2.56
|
|
Selected Fonseca Anamnestic Index Sub-Item Scores at Baseline and 3 Months
Q3 - Fatigue or Muscle Pain During Chewing, Baseline
|
5.75 points on a scale
Standard Deviation 3.35
|
6.25 points on a scale
Standard Deviation 3.19
|
7.50 points on a scale
Standard Deviation 3.44
|
|
Selected Fonseca Anamnestic Index Sub-Item Scores at Baseline and 3 Months
Q7 - Temporomandibular Joint Noise During Chewing or Mouth Opening, Baseline
|
5.50 points on a scale
Standard Deviation 3.20
|
5 points on a scale
Standard Deviation 3.24
|
6 points on a scale
Standard Deviation 3.08
|
|
Selected Fonseca Anamnestic Index Sub-Item Scores at Baseline and 3 Months
Q7 - Temporomandibular Joint Noise During Chewing or Mouth Opening, 3 Months
|
2.50 points on a scale
Standard Deviation 3.03
|
4.50 points on a scale
Standard Deviation 3.59
|
2.75 points on a scale
Standard Deviation 3.02
|
|
Selected Fonseca Anamnestic Index Sub-Item Scores at Baseline and 3 Months
Q8 - Clenching or Grinding Habit, Baseline
|
7.50 points on a scale
Standard Deviation 2.56
|
8.00 points on a scale
Standard Deviation 2.51
|
7.00 points on a scale
Standard Deviation 2.51
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: All participants with baseline and 3-month follow-up Fonseca Anamnestic Index severity category data were included in the analysis.
Fonseca Anamnestic Index severity categories were assessed at baseline and at the 3-month follow-up. Total Fonseca Anamnestic Index scores range from 0 to 100, with higher scores indicating more severe temporomandibular disorder-related symptoms. Severity categories were defined as absence of symptoms (0-15), mild symptoms (20-40), moderate symptoms (45-65), and severe symptoms (70-100).
Outcome measures
| Measure |
Occlusal Splint Therapy
n=20 Participants
Participants received custom-made maxillary stabilization splints and were instructed to wear them during sleep throughout the follow-up period.
|
Botulinum Toxin Type A Injection
n=20 Participants
Participants received a single session of intramuscular botulinum toxin type A injections into the masseter and temporalis muscles.
|
Combined Medical-Splint Therapy
n=20 Participants
Participants received a custom-made maxillary stabilization splint and short-term pharmacological therapy with thiocolchicoside and tenoxicam for acute symptom control.
|
|---|---|---|---|
|
Fonseca Anamnestic Index Severity Categories at Baseline and 3 Months
Baseline · Severe symptoms at baseline
|
8 Participants
|
6 Participants
|
13 Participants
|
|
Fonseca Anamnestic Index Severity Categories at Baseline and 3 Months
Baseline · Absence of symptoms
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Fonseca Anamnestic Index Severity Categories at Baseline and 3 Months
Baseline · Mild symptoms
|
4 Participants
|
4 Participants
|
1 Participants
|
|
Fonseca Anamnestic Index Severity Categories at Baseline and 3 Months
3 Months · Absence of symptoms
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Fonseca Anamnestic Index Severity Categories at Baseline and 3 Months
Baseline · Moderate symptoms at baseline
|
8 Participants
|
10 Participants
|
6 Participants
|
|
Fonseca Anamnestic Index Severity Categories at Baseline and 3 Months
3 Months · Mild symptoms
|
16 Participants
|
13 Participants
|
12 Participants
|
|
Fonseca Anamnestic Index Severity Categories at Baseline and 3 Months
3 Months · Moderate symptoms at baseline
|
2 Participants
|
5 Participants
|
4 Participants
|
|
Fonseca Anamnestic Index Severity Categories at Baseline and 3 Months
3 Months · Severe symptoms at baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: All participants assigned to the treatment arms were included in the adverse event analysis.
Treatment-related adverse events were monitored during the 3-month follow-up period. Participants were questioned about injection-related, medication-related, and splint-related adverse effects. Serious adverse events were defined as events requiring urgent medical care, hospitalization, treatment discontinuation, or resulting in persistent functional impairment.
Outcome measures
| Measure |
Occlusal Splint Therapy
n=20 Participants
Participants received custom-made maxillary stabilization splints and were instructed to wear them during sleep throughout the follow-up period.
|
Botulinum Toxin Type A Injection
n=20 Participants
Participants received a single session of intramuscular botulinum toxin type A injections into the masseter and temporalis muscles.
|
Combined Medical-Splint Therapy
n=20 Participants
Participants received a custom-made maxillary stabilization splint and short-term pharmacological therapy with thiocolchicoside and tenoxicam for acute symptom control.
|
|---|---|---|---|
|
Treatment-Related Adverse Events
Participants with treatment-related adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-Related Adverse Events
Participants without treatment-related adverse events
|
20 Participants
|
20 Participants
|
20 Participants
|
Adverse Events
Occlusal Splint Therapy
Botulinum Toxin Type A Injection
Combined Medical-Splint Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sedef Kurt CIRALIK
Recep Tayyip Erdogan University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place