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The goal of this clinical trial is to learn about the performance of botulinum toxin (BTX) injections for bruxism. Participants were divided into two groups according to the duration of the symptoms. The main question is whether BTX should be reserved for long-standing bruxism where the conventional methods failed or indicated as a first-line treatment. The investigator also compared the required doses and the frequency of treatment sessions between these two groups for a complete recovery.
The effectiveness of botulinum toxin (BTX) in treating bruxism is recognized and well-established. This study aims to provide the most suitable condition for a better performance of BTX injections.
This retrospective study of a single-arm trial was conducted using a medical database of 67 patients who suffered from bruxism between 2009 and 2015, and who had total recovery after injection sessions. Patients were divided into two groups based on the duration of their bruxism. The main outcomes measured were: pain relief, the total number of injection sessions until total recovery, doses of BTX used, and recovery duration between two consecutive sessions. The treatment was stopped when bruxism disappeared.
The investigator carried out injections using Dysport (Ipsen Pharma, Germany). The toxin was reconstituted with 0.9% sodium chloride solution so that 0.1 ml corresponded to 25 U. The patient received the same doses in each session, delivered to trigger points (TrPs). 0.05 ml was injected into each TrP.
The level of statistical significance was set at p < 0,01. The Chi-square test and ANOVA table were used to compare differences according to injection sessions, doses of BTX, TrPs, and recovery duration between the two groups (with long-standing bruxism, and recent bruxism).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duration of symptoms before BTX injections | Other | All the participants received BTX injections. Informed consent was obtained. Doses and sessions of injections varied between them according to the time of recurrence and the duration of the primary symptoms. The investigator carried out injections using Dysport (Ipsen Pharma, Germany). The toxin was reconstituted with 0.9% sodium chloride solution so that 0.1 ml corresponded to 25 U. The patient received the same doses in each session, delivered to TrPs detected by carefully palpating the muscle. 0.05 ml was injected into each TrPs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abobotulinumtoxin A injection for bruxism | Other | Trigger points were detected with careful palpating of the masticatory muscles (masseter and temporalis muscles) of patients suffering from bruxism. Each trigger point received 0,05 lm ol reconstituted solution of Abobotulinumtoxin A. Dysport (Ipsen Pharma, Germany) was reconstituted with 0.9% sodium chloride solution so that 0.1 ml corresponded to 25 U. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between doses of BTX and TrPs | The required doses of BTX were compared according to the number of trigger points found in both groups | 16 to 55 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the rate of injection sessions | The number of session of BTX injection for complete recovery was studied for both groups. | 16 to 55 months |
| Correlation of the long standing symptoms and the time to recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Imen Mehri Turki, Dr | University hospital Mohamed Tahar Maamouri. Nabeul, Tunisia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imen Mehri Turki | Nabeul | 8000 | Tunisia |
If the study is published in a medical journal, data will be available for researchers.
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| ID | Term |
|---|---|
| D009209 | Myofascial Pain Syndromes |
| D002012 | Bruxism |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C542869 | abobotulinumtoxinA |
| D001905 | Botulinum Toxins |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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A retrospective cohort study of two samples of participants ( group with long-standing for more than one year, group with recent symptoms for less than one year), with a single-arm trial (all the participants had the same treatment).
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|
The time to recurrence was compared between individuals of both groups.
| 16 to 55 months |
| D006184 |
| Habits |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |