Temporomandibular Joint DisordersNCT06508203
The Effect of Piroxicam Addition During Arthrocentesis on Mouth Opening and Postoperative Pain
A study testing arthrocentesis with lactate ringer only and arthrocentesis with lactate ringer followed by injection with piroxicam 2 ml (40mg) in people with Temporomandibular Joint Disorders, run by Ain Shams University at 1 site in Egypt.
Trial summary
TMDs is an ancient condition discovered thousands of years ago. Historians state that the ancient Egyptians were the first who managed TMDs. They manually treated joint dislocation by away similar to ours nowadays. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- arthrocentesis with lactate ringer only and arthrocentesis with lactate ringer followed by injection with piroxicam 2 ml (40mg)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Jun 2024
- Phase
- Interventional
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Age range 18-60 years both gender 2. Patient have gone on noninvasive therapy (occlusal stent) for three months without good prognosis 3. Internal derangement of TMJ (ant. Disc displacement with reduction) 4. Localized TMJ pain
- -
Who cannot join
- 1. Psychiatric illness 2. Previous TMJ surgery 3. Suffering from joint trauma 4. Cellulitis or severe laceration of pre-auricular skin covering TMJ
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Piroxicam Addition During Arthrocentesis on Mouth Opening and Postoperative Pain in the Management of Internal Derangement in Female Patients. (A Randomized Clinical Trial)
TMDs is an ancient condition discovered thousands of years ago. Historians state that the ancient Egyptians were the first who managed TMDs. They manually treated joint dislocation by away similar to ours nowadays. In the fifth century B.C, Hippocrates described technique for management of mandibular dislocation followed by concerns similar to fixation. At first the surgical management was performed to treat ankylosis and recurrent dislocation. The first surgical repositioning of articular disc done by Annandale in 1887. Lanz, Pringle and Wakeley were the first surgeons who did surgical removal of articular disc in the early 1900s. Their purpose was to manage signs and symptoms of TMDs which is pain, trismus clicking and limitation of movement. In addition, in the late 1800s, dentists' concerns changed toward occlusal adjustment during replacement of natural teeth and prosthetics procedures to avoid TMDs. At the beginning of the 20th century, dentists and otolaryngologists were ascribing head, face, ear, and jaw symptoms to pressure atrophy of the meniscus, glenoid fossa, and cranium as a result of the loss of posterior teeth. However, it was not until 1934 that "TMJ" became universally recognized when Costen, an otolaryngologist, published his discoveries claiming that pain in and around the jaw. Symptoms of Costen syndrome includes impaired hearing, ear pain, tinnitus, dizziness, burning sensation in throat and tongue, headache and trismus. Costen stated that the previous symptoms occur as a result of atrophic or perforated menisci, compression of Eustachian tube, erosion of bone of glenoid fossa and irritation of temporal and corda tympani nerve. On the other hand, in 1926, McCollum founded the Gnathological Society of California. Stallard had already coined the word "gnathology" in 1924. Gnathology is the harmonization of occlusal and inter jaw relationship for optimum dental and TMDs treatment. In addition, Kingsley in 1887 was the first to publish information on intraoral appliances (occlusal splint). Thompson in 1940s considered a leader in mandibular repositioning and rest position intraoral appliances. Shore advanced his concept of auto repositioning the mandible in the 1950s to fully seat the condyle, and Sears reintroduced pivot appliances in the late 1950s to "unload the condyle." Ramjford popularized the use of occlusal splints in the 1960s on the basis of his electromyographic. All the previous work depends on gnathonic concepts. Also, in 1960s Gelb introduced mandibular orthopedic repositioning appliance (MORA) to adjust condyle in its normal position. It has one risk which is irreversible changes in occlusal occurred with full time wear. By the late 1940s Schwartz explained the importance of masticatory musculature and specifically emotional tension as a primary etiologic factor for TMDs. Regional and referred pain of myofascial origin was considered to have a great effect on these conditions. It could be treated by physical medicine. By 1996 the AAOP published new guidelines on orofacial pain classification assessment and management. In addition, Guidelines for TMDs which are:
- Temporomandibular disorders (TMD) are defined as a collective term consists of a number of clinical problems that include the muscles of mastication, the temporomandibular joint and surrounding structures, or both.
- Temporomandibular disorders (TMD) are characterized by the following clinical presentation: pain in the muscles of mastication, the preauricular area and/or TMJ that is usually aggravated by manipulation or function; in addition to limited range of motion, abnormal mandibular movement, and locking of the joint. In addition to clicking
- Common complaints as headache, earache, and orofacial pain, as well as masticatory muscle hypertrophy and abnormal occlusal wearing addition to tinnitus, ear fullness.
- Cross-sectional epidemiologic studies of a specific nonpatient population show that approximately 75% have at least one sign and approximately 33% have at least one symptom; however, only 5% to 7% are estimated to need treatment. Prevalence data from clinical reports reveal a female to male ratio of 4:1 to 6:1 in persons seeking care, primarily in the second through the fourth decade of life.1 One of the recent treatment modalities of TMJ problems and TMDs is arthrocentesis (joint lavage).
Read the detailed description
Materials and Methodology Design of the study: Randomized controlled Trial (RCT) Site of the study: department of oral and maxillofacial surgery faculty of dentistry Ain shams university Criteria of inclusion: study done on 40 patients have the following criteria
- Age range 18-60 years both gender
- Patient have gone on noninvasive therapy (occlusal stent) for three months without good prognosis
- Internal derangement of TMJ (ant. Disc displacement with reduction)
- Localized TMJ pain
Criteria of exclusion:
- Psychiatric illness
- Previous TMJ surgery
- Suffering from joint trauma
- Cellulitis or severe laceration of pre-auricular skin covering TMJ
Intervention:
The patients divided into two groups. Group one contains 20 patients will be treated by arthrocentesis with lactate ringer only (control group). Group 2 contains 20 patients will be treated by arthrocentesis with lactate ringer followed by injection with piroxicam 2 ml (40mg) (study group). The patient should have done MRI shows internal derangement. Maximum mouth opening should be measured before procedure.
Arthrocentesis technique will be done under aseptic condition using betadine (betadine: /7.5/m/v povidone iodine USP Nile Company, under license by Switzerland), auriculotemporal nerve block anesthesia was included using carpule of mepivacaine (mepivacaine HCL2% with levonordefrin 1:20000, Alexandria Co. Pharmaceuticals, Alexandria, Egypt) and field infiltration at sites of joint penetration. External auditory canal is protected from accumulation of blood and fluid by a cotton pellet. A line should be drowned from outer canthus of the eye to ear tragus (canthal tragus line). The first needle (inlet) corresponding to glenoid fossa should be placed 1 cm from mid tragus and 2mm below canthal tragus line. The second needle (outlet) related to articular eminence should be placed 1cm from first needle and 1 cm below canthal tragus line. 20-gauge needle was introduced to posterior aspect of glenoid fossa first mark (inlet) and 18-gauge needle is introduced into second mark (outlet). 200ml of lactate ringer solution is introduced into inlet syringe the joint is manipulated by closing opening lateral movement and protrusion to allow flow of solution and release of adhesions and inflammatory mediators. Then the lactate ringer is collected in kidney dish through the outlet syringe. This technique should be done in both groups (1\&2). In group 2 only after this procedure is done, we use the first needle in injection of 2 ml (40mg) piroxicam (feldene:1 ml ampoule piroxicam manufactured by Pfizer S.A.E) into the joint space. After injection is done the joint should be manipulated in different directions.
After the procedures for both groups postoperative medication should be prescribed which is antibiotics. Post-operative instruction should be followed. Which is soft diet and home physical therapy containing application of moist heat and mandibular exercise as opening, closing, protrusion, extrusion and lateral movement 4 times per day. 8 Data collection: data will be collected twice inter examiner relatability. Measurements and assessment: Follow-up for the first day there may be numbness around the auricle which affect hearing sensation end by the end of local anesthetic effect. Also, edema may occur which need prescription of antiedematous and anti inflammatory. then follow up after 1 week then after 2 weeks then after month then after 3 months then after 6 months. In the follow up we must notice the maximum mouth opening without pain, lateral excursion during opening and closing mouth and visual analogue scale of pain.
Statistics: independent simple T-test. Ethics: the study is approved by ethical committee of Ain Shams University and the patients sign informed consent after the procedures have been described in details.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- arthrocentesis with lactate ringer only, arthrocentesis with lactate ringer followed by injection with piroxicam 2 ml (40mg)
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthrocentesis with lactate ringer onlyProcedure or surgery
classical arthrocentesis with lactate ringer only (control group).
arthrocentesis with lactate ringer followed by injection with piroxicam 2 ml (40mg)Procedure or surgery
classical arthrocentesis with lactate ringer followed by injection with piroxicam 2 ml (40mg)
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | 20 patients will be treated by arthrocentesis with lactate ringer followed by injection with piroxicam 2 ml (40mg) (study group). Receives: Procedure: arthrocentesis with lactate ringer followed by injection with piroxicam 2 ml (40mg) |
| control | Active comparator | 20 patients will be treated by arthrocentesis with lactate ringer only (control group). Receives: Procedure: arthrocentesis with lactate ringer only |
What is being measured
The primary outcome is the main question the study is designed to answer.
mouth opening
un assited mouth opening in mm
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 Jan 2024
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two arm randomized clinical trial with study group and positive control
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508203
- Sponsor's protocol ID
- 953mscfdasu
- Status last verified
- Jan 2024
- First submitted
- 13 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: based on publication requirment
Publications
Baruffi S, Saber AY, Martins T, Varacallo MA. Shoulder Arthrocentesis Technique. 2023 Aug 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK519052/
PubMed 30085594
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Piroxicam Addition During Arthrocentesis on Mouth Opening and Postoperative Pain in the Management of Internal Derangement in Female Patients. (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06508203
- Acronym / sponsor ID
- 953mscfdasu
- Conditions
- Temporomandibular Joint Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 18 Jul 2024 (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.
TMDs is an ancient condition discovered thousands of years ago. Historians state that the ancient Egyptians were the first who managed TMDs. They manually treated joint dislocation by away similar to ours nowadays. In the fifth century B.C, Hippocrates described technique for management of mandibular dislocation followed by concerns similar to fixation. At first the surgical management was performed to treat ankylosis and recurrent dislocation. The first surgical repositioning of articular disc done by Annandale in 1887. Lanz, Pringle and Wakeley were the first surgeons who did surgical removal of articular disc in the early 1900s. Their purpose was to manage signs and symptoms of TMDs which is pain, trismus clicking and limitation of movement. In addition, in the late 1800s, dentists' concerns changed toward occlusal adjustment during replacement of natural teeth and prosthetics procedures to avoid TMDs. At the beginning of the 20th century, dentists and otolaryngologists were ascribing head, face, ear, and jaw symptoms to pressure atrophy of the meniscus, glenoid fossa, and cranium as a result of the loss of posterior teeth. However, it was not until 1934 that "TMJ" became universally recognized when Costen, an otolaryngologist, published his discoveries claiming that pain in and around the jaw. Symptoms of Costen syndrome includes impaired hearing, ear pain, tinnitus, dizziness, burning sensation in throat and tongue, headache and trismus. Costen stated that the previous symptoms occur as a result of atrophic or perforated menisci, compression of Eustachian tube, erosion of bone of glenoid fossa and irritation of temporal and corda tympani nerve. On the other hand, in 1926, McCollum founded the Gnathological Society of California. Stallard had already coined the word "gnathology" in 1924. Gnathology is the harmonization of occlusal and inter jaw relationship for optimum dental and TMDs treatment. In addition, Kingsley in 1887 was the first to publish information on intraoral appliances (occlusal splint). Thompson in 1940s considered a leader in mandibular repositioning and rest position intraoral appliances. Shore advanced his concept of auto repositioning the mandible in the 1950s to fully seat the condyle, and Sears reintroduced pivot appliances in the late 1950s to "unload the condyle." Ramjford popularized the use of occlusal splints in the 1960s on the basis of his electromyographic. All the previous work depends on gnathonic concepts. Also, in 1960s Gelb introduced mandibular orthopedic repositioning appliance (MORA) to adjust condyle in its normal position. It has one risk which is irreversible changes in occlusal occurred with full time wear. By the late 1940s Schwartz explained the importance of masticatory musculature and specifically emotional tension as a primary etiologic factor for TMDs. Regional and referred pain of myofascial origin was considered to have a great effect on these conditions. It could be treated by physical medicine. By 1996 the AAOP published new guidelines on orofacial pain classification assessment and management. In addition, Guidelines for TMDs which are:
- Temporomandibular disorders (TMD) are defined as a collective term consists of a number of clinical problems that include the muscles of mastication, the temporomandibular joint and surrounding structures, or both.
- Temporomandibular disorders (TMD) are characterized by the following clinical presentation: pain in the muscles of mastication, the preauricular area and/or TMJ that is usually aggravated by manipulation or function; in addition to limited range of motion, abnormal mandibular movement, and locking of the joint. In addition to clicking
- Common complaints as headache, earache, and orofacial pain, as well as masticatory muscle hypertrophy and abnormal occlusal wearing addition to tinnitus, ear fullness.
- Cross-sectional epidemiologic studies of a specific nonpatient population show that approximately 75% have at least one sign and approximately 33% have at least one symptom; however, only 5% to 7% are estimated to need treatment. Prevalence data from clinical reports reveal a female to male ratio of 4:1 to 6:1 in persons seeking care, primarily in the second through the fourth decade of life.1 One of the recent treatment modalities of TMJ problems and TMDs is arthrocentesis (joint lavage).
Detailed description
Materials and Methodology Design of the study: Randomized controlled Trial (RCT) Site of the study: department of oral and maxillofacial surgery faculty of dentistry Ain shams university Criteria of inclusion: study done on 40 patients have the following criteria
- Age range 18-60 years both gender
- Patient have gone on noninvasive therapy (occlusal stent) for three months without good prognosis
- Internal derangement of TMJ (ant. Disc displacement with reduction)
- Localized TMJ pain
Criteria of exclusion:
- Psychiatric illness
- Previous TMJ surgery
- Suffering from joint trauma
- Cellulitis or severe laceration of pre-auricular skin covering TMJ
Intervention:
The patients divided into two groups. Group one contains 20 patients will be treated by arthrocentesis with lactate ringer only (control group). Group 2 contains 20 patients will be treated by arthrocentesis with lactate ringer followed by injection with piroxicam 2 ml (40mg) (study group). The patient should have done MRI shows internal derangement. Maximum mouth opening should be measured before procedure.
Arthrocentesis technique will be done under aseptic condition using betadine (betadine: /7.5/m/v povidone iodine USP Nile Company, under license by Switzerland), auriculotemporal nerve block anesthesia was included using carpule of mepivacaine (mepivacaine HCL2% with levonordefrin 1:20000, Alexandria Co. Pharmaceuticals, Alexandria, Egypt) and field infiltration at sites of joint penetration. External auditory canal is protected from accumulation of blood and fluid by a cotton pellet. A line should be drowned from outer canthus of the eye to ear tragus (canthal tragus line). The first needle (inlet) corresponding to glenoid fossa should be placed 1 cm from mid tragus and 2mm below canthal tragus line. The second needle (outlet) related to articular eminence should be placed 1cm from first needle and 1 cm below canthal tragus line. 20-gauge needle was introduced to posterior aspect of glenoid fossa first mark (inlet) and 18-gauge needle is introduced into second mark (outlet). 200ml of lactate ringer solution is introduced into inlet syringe the joint is manipulated by closing opening lateral movement and protrusion to allow flow of solution and release of adhesions and inflammatory mediators. Then the lactate ringer is collected in kidney dish through the outlet syringe. This technique should be done in both groups (1\&2). In group 2 only after this procedure is done, we use the first needle in injection of 2 ml (40mg) piroxicam (feldene:1 ml ampoule piroxicam manufactured by Pfizer S.A.E) into the joint space. After injection is done the joint should be manipulated in different directions.
After the procedures for both groups postoperative medication should be prescribed which is antibiotics. Post-operative instruction should be followed. Which is soft diet and home physical therapy containing application of moist heat and mandibular exercise as opening, closing, protrusion, extrusion and lateral movement 4 times per day. 8 Data collection: data will be collected twice inter examiner relatability. Measurements and assessment: Follow-up for the first day there may be numbness around the auricle which affect hearing sensation end by the end of local anesthetic effect. Also, edema may occur which need prescription of antiedematous and anti inflammatory. then follow up after 1 week then after 2 weeks then after month then after 3 months then after 6 months. In the follow up we must notice the maximum mouth opening without pain, lateral excursion during opening and closing mouth and visual analogue scale of pain.
Statistics: independent simple T-test. Ethics: the study is approved by ethical committee of Ain Shams University and the patients sign informed consent after the procedures have been described in details.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- two arm randomized clinical trial with study group and positive control
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Procedure: arthrocentesis with lactate ringer followed by injection with piroxicam 2 ml (40mg)20 patients will be treated by arthrocentesis with lactate ringer followed by injection with piroxicam 2 ml (40mg) (study group). |
| control | Active comparator | Procedure: arthrocentesis with lactate ringer only20 patients will be treated by arthrocentesis with lactate ringer only (control group). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. Age range 18-60 years both gender 2. Patient have gone on noninvasive therapy (occlusal stent) for three months without good prognosis 3. Internal derangement of TMJ (ant. Disc displacement with reduction) 4. Localized TMJ pain
- -
Key exclusion criteria (1 listed)
- 1. Psychiatric illness 2. Previous TMJ surgery 3. Suffering from joint trauma 4. Cellulitis or severe laceration of pre-auricular skin covering TMJ
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 |
|---|---|---|
| arthrocentesis with lactate ringer onlyclassical arthrocentesis with lactate ringer only (control group). | Procedure or surgery | control |
| arthrocentesis with lactate ringer followed by injection with piroxicam 2 ml (40mg)classical arthrocentesis with lactate ringer followed by injection with piroxicam 2 ml (40mg) | Procedure or surgery | study group |
Primary outcome
mouth opening
Time frame: six months
un assited mouth opening in mm
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 18 Jul 2024.
- Results publication: PubMed 30085594Baruffi S, Saber AY, Martins T, Varacallo MA. Shoulder Arthrocentesis Technique. 2023 Aug 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK519052/
- Individual participant dataSharing planned: Undecided. based on publication requirment
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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 study testing arthrocentesis with lactate ringer only and arthrocentesis with lactate ringer followed by injection with piroxicam 2 ml (40mg) in people with Temporomandibular Joint Disorders, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 1 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 18 Jul 2024. 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 Egypt. 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.
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?
mouth opening (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06508203, which also lists 1 linked publication.
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 18 Jul 2024.