Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508203
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-13
Brief Title:
The Effect of Piroxicam Addition During Arthrocentesis on Mouth Opening and Postoperative Pain
Sponsor:
None
Organization:
None
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 In the fifth century BC 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
1 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
2 Temporomandibular disorders TMD are characterized by the following clinical presentation pain in the muscles of mastication the preauricular area andor 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
3 Common complaints as headache earache and orofacial pain as well as masticatory muscle hypertrophy and abnormal occlusal wearing addition to tinnitus ear fullness
4 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 41 to 61 in persons seeking care primarily in the second through the fourth decade of life1 One of the recent treatment modalities of TMJ problems and TMDs is arthrocentesis joint lavage
1 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
2 Temporomandibular disorders TMD are characterized by the following clinical presentation pain in the muscles of mastication the preauricular area andor 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
3 Common complaints as headache earache and orofacial pain as well as masticatory muscle hypertrophy and abnormal occlusal wearing addition to tinnitus ear fullness
4 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 41 to 61 in persons seeking care primarily in the second through the fourth decade of life1 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
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
Criteria of exclusion
1 Psychiatric illness
2 Previous TMJ surgery
3 Suffering from joint trauma
4 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 75mv povidone iodine USP Nile Company under license by Switzerland auriculotemporal nerve block anesthesia was included using carpule of mepivacaine mepivacaine HCL2 with levonordefrin 120000 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 12 In group 2 only after this procedure is done we use the first needle in injection of 2 ml 40mg piroxicam feldene1 ml ampoule piroxicam manufactured by Pfizer SAE 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
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
Criteria of exclusion
1 Psychiatric illness
2 Previous TMJ surgery
3 Suffering from joint trauma
4 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 75mv povidone iodine USP Nile Company under license by Switzerland auriculotemporal nerve block anesthesia was included using carpule of mepivacaine mepivacaine HCL2 with levonordefrin 120000 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 12 In group 2 only after this procedure is done we use the first needle in injection of 2 ml 40mg piroxicam feldene1 ml ampoule piroxicam manufactured by Pfizer SAE 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None