Efficacy of Oral nutraceutical as adjunct to arthrocentesis - iPRF in Temporomandibular joint derangements - A Randomized Control Trial
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Vaibhav Alone
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- To evaluate and compare the analgesic efficacy oral nutraceutical (Collagen + sodium hyaluronate +
Overview
Brief Summary
In this randomized control study, we will be comparing the the to compare the efficacy of oral nutraceutical (Collagen + sodium
hyaluronate + Curcumin + Boswellia + Piperine) as adjunct to arthrocentesis - iPRF in
management of patients with Temporomandibular joint derangement patients.Patient will be recruited from Dentak OPD of the AIIMS , JODHPUR. A total of 30 patients will be randomly divided into 2 group
those who are diagnosed with Wilkes’s type III and IV TMD by means of clinical and radiographic magnetic
resonance imaging (MRI)) evaluation.
Group l – Arthrocentesis + I PRF group (control group)
Group ll – (Treatment group) - Arthrocentesis + I PRF + oral nutraceutical supplement(Tab Cartilox Go) in
OD dose for 2 months.MMO will be measured as the distance between the incisal edge of the upper and lower central incisors using a
vernier calliper. MMO measurements will be performed preoperatively ,immediately after the procedure , and
at 1 week, 1 month, 3 months and 6 months postoperatively. Lateral movements are measured by instructing the patient to move his/her mandible as far as possible to one
side, and the lateral movements are recorded. For convenience the distance between the fixed maxillary midline
and the shift of the mandibular midline on lateral excursion is measured. Any lateral movement less than 8 mm
suggests restricted movement at 1 week, 1 month, 3 months and 6 months postoperatively. The protrusive movement can be obtained by instructing the patient to close in centric position and slide the
lower jaw as far forward as possible. The overjet may also be recorded. Protrusive movements are recorded by
adding these two readings. Protrusive movements are considered to be restricted if it is less than 7 mm at 1
week, 1 month, 3 months and 6 months postoperatively. Placing two fingers over each condyle the patient is instructed to make a maximal jaw opening. During this
movement, clicking sounds should be noted at1 week, 1 month, 3 months and 6 months postoperatively.All joints will be scanned with the patient’s mouth closed in maximum intercuspation and opened maximally,
before procedure and at3 rd , and 6 th months after the procedure. The MRI studies will be independently examined
by 1 of the investigators, who are blinded to the patients’ names and clinical information. Differences in
preoperative and postoperative disk position, mobility, morphology, Joint effusion, Bone marrow edema and
Osteoarthrosis on MRI.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients who have given written informed consent to be a part of the study.
- •Adult patients of either sex Age 18-60 years
- •ASA I or ll 4.Patients with Wilkes classification of Internal Derangement stage III and stage IV only with positive Mahan test.
Exclusion Criteria
- •Age <18 years and >60 years
- •Pregnant or lactating female
- •Patients with severe debilitating conditions such as uncontrolled diabetes mellitus, uncontrolled hypertension, cardio respiratory conditions, previous history of cerebrovascular accidents, myocardial infarction, coronary artery disease, impaired renal and hepatic function and coagulation disorders 4.Patients on antiplatelet/anticoagulant therapy.
- •5.autoimmune diseases affecting joints 6.Significant mechanical obstruction that prevents mouth opening, 7.Acute capsulitis , synovitis 8.Benign or malignant temporomandibular joint lesions, 9.Neurological disorders.
Outcomes
Primary Outcomes
To evaluate and compare the analgesic efficacy oral nutraceutical (Collagen + sodium hyaluronate +
Time Frame: DAY 0 | 7 DAY | 14 DAY | 1 MONTH | 3 MONTHS | 6 MONTHS
Curcurmin + Boswellia + piperine) as adjunct to arthrocentesis- iPRF in management of patients with
Time Frame: DAY 0 | 7 DAY | 14 DAY | 1 MONTH | 3 MONTHS | 6 MONTHS
Temporomandibular joint derangement .
Time Frame: DAY 0 | 7 DAY | 14 DAY | 1 MONTH | 3 MONTHS | 6 MONTHS
Secondary Outcomes
- 1. To evaluate & compare the effect on jaw function (mouth opening, lateral movement, protrusive(movements) of Temporomandibular joint derangement patients in oral nutraceutical ( collagen +)
Investigators
Dr Ankita Chugh
All India Institute of Medical Sciences AIIMS - Jodhpur