BruxismPhase 4NCT07732751
Botulinum Toxin Type A Versus Oral Ibuprofen for Bruxism
A Phase 4 study testing Botulinum Toxin Type A 100U and Ibuprofen in people with Bruxism and Myofascial Pain, run by Cyprus Health and Social Sciences University at 1 site in Cyprus.
Trial summary
This randomized controlled trial evaluated the effectiveness of Botulinum Toxin Type A compared with oral ibuprofen in reducing pain and improving oral health-related quality of life in patients with sleep bruxism and jaw muscle pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bruxism, Myofascial Pain
- What is being tested?
- Botulinum Toxin Type A 100U and Ibuprofen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCyprus
- Study dates
- 6 Feb 2026to 26 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Clinical diagnosis of sleep bruxism.
- Presence of jaw muscle pain.
- Ability to provide written informed consent.
Who cannot join
- Pregnancy or breastfeeding.
- Previous botulinum toxin treatment within 6 months.
- Neuromuscular disorders.
- Allergy to botulinum toxin or ibuprofen.
- Use of medications affecting neuromuscular function.
Trial locations and contacts
1 site in 1 country.
Cyprus1 site
New Cyprus Health and Social Sciences University
Güzelyurt (Morphou), Northern Cyprus, 99750
About this study
Official title: The Effect of Botulinum Toxin Type A on Quality of Life During Bruxism Treatment: A Randomized Controlled Trial Comparing Botulinum Toxin Type A With Oral Ibuprofen in Patients With Jaw Muscle Pain
This randomized controlled trial evaluated the effectiveness of Botulinum Toxin Type A compared with oral ibuprofen in reducing pain and improving oral health-related quality of life in patients with sleep bruxism and jaw muscle pain. Forty participants diagnosed with sleep bruxism were randomly assigned to receive either Botulinum Toxin Type A injections into the masseter and temporalis muscles or oral ibuprofen therapy. Participants were followed for 20 weeks. The primary outcome was pain intensity measured using the Visual Analogue Scale (VAS). Secondary outcomes included oral health-related quality of life assessed using the Oral Health Impact Profile-14 (OHIP-14), muscle tenderness, and mandibular function.
Read the detailed description
Bruxism is a parafunctional masticatory muscle activity characterized by repetitive clenching or grinding of the teeth and/or bracing or thrusting of the mandible. It is commonly associated with jaw muscle pain, muscle tenderness, fatigue, restricted mandibular movement, and impairment of oral health-related quality of life. Conventional treatment strategies include behavioral interventions, occlusal splints, physical therapy, and pharmacological agents such as non-steroidal anti-inflammatory drugs (NSAIDs). However, these approaches may not provide adequate symptom control in all patients, particularly those with persistent muscular pain.
Botulinum Toxin Type A has been increasingly investigated as an alternative therapeutic option because it produces temporary chemodenervation by inhibiting the presynaptic release of acetylcholine at the neuromuscular junction. This mechanism reduces excessive muscle contraction and may alleviate pain, decrease muscle tenderness, and improve mandibular function. Despite encouraging evidence from previous studies, further randomized controlled trials comparing Botulinum Toxin Type A with conventional pharmacological therapy remain necessary to establish its clinical effectiveness.
The present study was designed as a prospective, randomized, controlled clinical trial conducted at the Department of Dentistry, New Cyprus Health and Social Sciences University. Forty adult patients diagnosed with sleep bruxism associated with jaw muscle pain were enrolled after meeting the predefined eligibility criteria and providing written informed consent. Participants were randomly allocated into two equal treatment groups. The intervention group received Botulinum Toxin Type A injections administered into the bilateral masseter and temporalis muscles according to the study protocol, whereas the control group received oral ibuprofen therapy.
Clinical assessments were performed at baseline and during a 20-week follow-up period. Pain intensity was evaluated using the Visual Analogue Scale (VAS), while oral health-related quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14). Additional clinical outcomes included muscle tenderness on palpation and mandibular function. Safety assessments were conducted throughout the study by monitoring treatment-related adverse events and documenting any unexpected clinical findings.
The primary objective of this trial was to compare the effectiveness of Botulinum Toxin Type A with oral ibuprofen in reducing pain intensity in patients with sleep bruxism. Secondary objectives included evaluating changes in oral health-related quality of life, muscle tenderness, mandibular function, and the overall clinical response following treatment. The findings of this study are intended to provide evidence regarding the comparative effectiveness of Botulinum Toxin Type A as a minimally invasive treatment option for patients experiencing jaw muscle pain related to sleep bruxism.
- Conditions
- Bruxism, Myofascial Pain
- Being tested
- Botulinum Toxin Type A 100U, Ibuprofen
- Keywords
- Botulinum Toxin Type A, Botulinum Neurotoxin Type A, Bruxism, Jaw Muscle Pain, Myofascial Pain, Oral Ibuprofen, Nonsteroidal Anti-inflammatory Drugs, Visual Analogue Scale, OHIP-14, Oral Health-Related Quality of Life, Randomized Controlled Trial, Masseter Muscle, Temporalis Muscle
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A 100UDrug
Also called Otesaly
Botulinum Toxin Type A was administered by intramuscular injection into the bilateral masseter and temporalis muscles according to the study protocol. The intervention was performed once at baseline, and participants were followed for 20 weeks to evaluate pain intensity, oral health-related quality of life, muscle tenderness, and mandibular function.
IbuprofenDrug
Also called Ibuprofen (600mg)
Ibuprofen was administered orally at a dose of 600 mg three times daily for one week according to the study protocol. Participants were followed for 20 weeks to evaluate pain intensity, oral health-related quality of life, muscle tenderness, and mandibular function.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Type A | Experimental | Participants in this arm received Botulinum Toxin Type A (Otesaly® Botulinum Toxin Type A) was administered under aseptic conditions. A total dose of 100 units was used for each patient. Thirty units were injected into each masseter muscle and distributed across three standardized injection points (10 units per point) located within the prominent belly of the muscle. Twenty units were injected into each temporalis muscle and distributed across two injection points (10 units per point) within the anterior portion of the muscle. The injection sites were identified through clinical palpation while the patient performed maximal clenching to ensure accurate localization of muscle activity. All injections were performed using a standardized technique to ensure consistency among participants and minimize treatment variability. Receives: Drug: Botulinum Toxin Type A 100U |
| Oral Ibuprofen | Active comparator | Participants in this arm received oral ibuprofen with 600 mg administered three times daily for one week. Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity Measured by the Visual Analogue Scale (VAS)
Pain intensity will be assessed using the 10-point Visual Analogue Scale (VAS). Participants will mark their pain level on a horizontal line ranging from 0 (no pain) to 10 (worst pain imaginable). Pain severity may be interpreted as mild (1-3), moderate (4-6), or severe (7-9). The outcome measure will be the mean change in VAS score from baseline to each follow-up assessment. Lower scores indicate reduced pain intensity and improved treatment outcome.
Measured: Baseline to Week 20 (week 1, week 2, week 4, week 8, week 12, week 16, and week 20).
Secondary outcomes (3)
Change in Oral Health-Related Quality of Life (OHIP-14)
Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14), a validated questionnaire consisting of 14 items that evaluate the impact of oral conditions on functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Each item is scored on a 5-point Likert scale (0 = Never, 1 = Hardly ever, 2 = Occasionally, 3 = Fairly often, and 4 = Very often), resulting in a total score ranging from 0 to 56. Higher total scores indicate poorer oral health-related quality of life, whereas lower scores indicate better quality of life. The outcome measure will be the mean change in the total OHIP-14 score from baseline to each follow-up assessment.
Measured: Baseline to Week 20 (week 1, week 2, week 4, week 8, week 12, week 16, and week 20).
Change in Jaw Muscle Tenderness Assessed by Standardized Clinical Palpation
Jaw muscle tenderness will be assessed by standardized bilateral manual palpation of the masseter and temporalis muscles using a consistent clinical examination protocol at every follow-up visit. The same trained, blinded outcome assessor will perform all examinations throughout the study to minimize inter-examiner variability. Tenderness will be evaluated by applying gentle, standardized digital pressure over predetermined anatomical sites of each muscle and recording the participant's pain response. The outcome measure will be the change in muscle tenderness from baseline to each scheduled follow-up visit, with reduced tenderness indicating clinical improvement following treatment.
Measured: Baseline to Week 20 (week 1, week 2, week 4, week 8, week 12, week 16, and week 20).
Change in Mandibular Functional Performance Assessed by Clinical Examination
Mandibular function will be evaluated using a standardized clinical functional examination performed by the same blinded outcome assessor at each follow-up visit. The assessment will include evaluation of maximum mouth opening, mandibular movements (opening, lateral excursion, and protrusion), functional jaw performance during routine clinical examination, and the presence of movement-related discomfort or functional limitation. The outcome measure will be the overall change in mandibular functional performance from baseline to each scheduled follow-up visit, with improved mandibular function indicating a better therapeutic response.
Measured: Baseline to Week 20 (week 1, week 2, week 4, week 8, week 12, week 16, and week 20).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start6 Feb 2026
- Primary completion26 Jun 2026
- Study completion26 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel treatment groups. The intervention group received Botulinum Toxin Type A injections into the bilateral masseter and temporalis muscles, while the control group received oral ibuprofen. Participants remained in their assigned treatment group throughout the 20-week follow-up period, and no crossover between treatment groups occurred.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyprus Health and Social Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faisal Omar Basheer Mojbur, Cyprus Health and Social Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732751
- Sponsor's protocol ID
- KSTU-2026-014
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because participant consent did not include permission for data sharing, and confidentiality of participant information will be maintained.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Botulinum Toxin Type A on Quality of Life During Bruxism Treatment: A Randomized Controlled Trial Comparing Botulinum Toxin Type A With Oral Ibuprofen in Patients With Jaw Muscle Pain
- ClinicalTrials.gov ID
- NCT07732751
- Acronym / sponsor ID
- KSTU-2026-014
- Conditions
- Bruxism, Myofascial Pain
- Keywords
- Botulinum Toxin Type A, Botulinum Neurotoxin Type A, Bruxism, Jaw Muscle Pain, Myofascial Pain, Oral Ibuprofen, Nonsteroidal Anti-inflammatory Drugs, Visual Analogue Scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cyprus Health and Social Sciences UniversityUniversity, hospital or other
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial evaluated the effectiveness of Botulinum Toxin Type A compared with oral ibuprofen in reducing pain and improving oral health-related quality of life in patients with sleep bruxism and jaw muscle pain. Forty participants diagnosed with sleep bruxism were randomly assigned to receive either Botulinum Toxin Type A injections into the masseter and temporalis muscles or oral ibuprofen therapy. Participants were followed for 20 weeks. The primary outcome was pain intensity measured using the Visual Analogue Scale (VAS). Secondary outcomes included oral health-related quality of life assessed using the Oral Health Impact Profile-14 (OHIP-14), muscle tenderness, and mandibular function.
Detailed description
Bruxism is a parafunctional masticatory muscle activity characterized by repetitive clenching or grinding of the teeth and/or bracing or thrusting of the mandible. It is commonly associated with jaw muscle pain, muscle tenderness, fatigue, restricted mandibular movement, and impairment of oral health-related quality of life. Conventional treatment strategies include behavioral interventions, occlusal splints, physical therapy, and pharmacological agents such as non-steroidal anti-inflammatory drugs (NSAIDs). However, these approaches may not provide adequate symptom control in all patients, particularly those with persistent muscular pain.
Botulinum Toxin Type A has been increasingly investigated as an alternative therapeutic option because it produces temporary chemodenervation by inhibiting the presynaptic release of acetylcholine at the neuromuscular junction. This mechanism reduces excessive muscle contraction and may alleviate pain, decrease muscle tenderness, and improve mandibular function. Despite encouraging evidence from previous studies, further randomized controlled trials comparing Botulinum Toxin Type A with conventional pharmacological therapy remain necessary to establish its clinical effectiveness.
The present study was designed as a prospective, randomized, controlled clinical trial conducted at the Department of Dentistry, New Cyprus Health and Social Sciences University. Forty adult patients diagnosed with sleep bruxism associated with jaw muscle pain were enrolled after meeting the predefined eligibility criteria and providing written informed consent. Participants were randomly allocated into two equal treatment groups. The intervention group received Botulinum Toxin Type A injections administered into the bilateral masseter and temporalis muscles according to the study protocol, whereas the control group received oral ibuprofen therapy.
Clinical assessments were performed at baseline and during a 20-week follow-up period. Pain intensity was evaluated using the Visual Analogue Scale (VAS), while oral health-related quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14). Additional clinical outcomes included muscle tenderness on palpation and mandibular function. Safety assessments were conducted throughout the study by monitoring treatment-related adverse events and documenting any unexpected clinical findings.
The primary objective of this trial was to compare the effectiveness of Botulinum Toxin Type A with oral ibuprofen in reducing pain intensity in patients with sleep bruxism. Secondary objectives included evaluating changes in oral health-related quality of life, muscle tenderness, mandibular function, and the overall clinical response following treatment. The findings of this study are intended to provide evidence regarding the comparative effectiveness of Botulinum Toxin Type A as a minimally invasive treatment option for patients experiencing jaw muscle pain related to sleep bruxism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel treatment groups. The intervention group received Botulinum Toxin Type A injections into the bilateral masseter and temporalis muscles, while the control group received oral ibuprofen. Participants remained in their assigned treatment group throughout the 20-week follow-up period, and no crossover between treatment groups occurred.
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Type A | Experimental | Drug: Botulinum Toxin Type A 100UParticipants in this arm received Botulinum Toxin Type A (Otesaly® Botulinum Toxin Type A) was administered under aseptic conditions. A total dose of 100 units was used for each patient. Thirty units were injected into each masseter muscle and distributed across three standardized injection points (10 units per point) located within the prominent belly of the muscle. Twenty units were injected into each temporalis muscle and distributed across two injection points (10 units per point) within the anterior portion of the muscle. The injection sites were identified through clinical palpation while the patient performed maximal clenching to ensure accurate localization of muscle activity. All injections were performed using a standardized technique to ensure consistency among participants and minimize treatment variability. |
| Oral Ibuprofen | Active comparator | Drug: IbuprofenParticipants in this arm received oral ibuprofen with 600 mg administered three times daily for one week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Clinical diagnosis of sleep bruxism.
- Presence of jaw muscle pain.
- Ability to provide written informed consent.
Key exclusion criteria (5 listed)
- Pregnancy or breastfeeding.
- Previous botulinum toxin treatment within 6 months.
- Neuromuscular disorders.
- Allergy to botulinum toxin or ibuprofen.
- Use of medications affecting neuromuscular function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type A 100UAlso: OtesalyBotulinum Toxin Type A was administered by intramuscular injection into the bilateral masseter and temporalis muscles according to the study protocol. The intervention was performed once at baseline, and participants were followed for 20 weeks to evaluate pain intensity, oral health-related quality of life, muscle tenderness, and mandibular function. | Drug | Botulinum Toxin Type A |
| IbuprofenAlso: Ibuprofen (600mg)Ibuprofen was administered orally at a dose of 600 mg three times daily for one week according to the study protocol. Participants were followed for 20 weeks to evaluate pain intensity, oral health-related quality of life, muscle tenderness, and mandibular function. | Drug | Oral Ibuprofen |
Primary outcome
Change in Pain Intensity Measured by the Visual Analogue Scale (VAS)
Time frame: Baseline to Week 20 (week 1, week 2, week 4, week 8, week 12, week 16, and week 20).
Pain intensity will be assessed using the 10-point Visual Analogue Scale (VAS). Participants will mark their pain level on a horizontal line ranging from 0 (no pain) to 10 (worst pain imaginable). Pain severity may be interpreted as mild (1-3), moderate (4-6), or severe (7-9). The outcome measure will be the mean change in VAS score from baseline to each follow-up assessment. Lower scores indicate reduced pain intensity and improved treatment outcome.
3 secondary outcomes
Change in Oral Health-Related Quality of Life (OHIP-14)
Time frame: Baseline to Week 20 (week 1, week 2, week 4, week 8, week 12, week 16, and week 20).
Change in Jaw Muscle Tenderness Assessed by Standardized Clinical Palpation
Time frame: Baseline to Week 20 (week 1, week 2, week 4, week 8, week 12, week 16, and week 20).
Change in Mandibular Functional Performance Assessed by Clinical Examination
Time frame: Baseline to Week 20 (week 1, week 2, week 4, week 8, week 12, week 16, and week 20).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because participant consent did not include permission for data sharing, and confidentiality of participant information will be maintained.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin Type A 100U and Ibuprofen in people with Bruxism and Myofascial Pain, run by Cyprus Health and Social Sciences University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity Measured by the Visual Analogue Scale (VAS) (time frame: Baseline to Week 20 (week 1, week 2, week 4, week 8, week 12, week 16, and week 20).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.