- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05422703
Manual Therapy and Kinesio Taping on Temporomandibular Joint Dysfunction Following Oral Surgeries
Combined Effect of Manual Therapy and Kinesio Taping on Temporomandibular Joint Dysfunction Following Oral Surgeries
Study Overview
Status
Conditions
Detailed Description
Oral surgery concerned with the diagnosis and surgical treatment of congenital or acquired diseases, dysfunction, defects or injuries of the mouth and jaw. Oral surgeries include various types such as impacted wisdom tooth surgery, oral cyst enucleation (cystectomy), surgical incision and drainage of odontogenic abscess, oral tumor excision and open reduction and internal fixation of mandibular fracture (ORIF).
Temporomandibular joint dysfunction: It is one of post operative complications that occur post oral surgeries which include several symptoms as pain,edema and trismus. Pain is the most common and limiting clinical manifestation of this dysfunction, as well as decreased mobility of the jaw, both of which impacts quality of life. The multifactor etiology of temporomandibular joint dysfunction often requires multidisciplinary healthcare professionals to manage difficult symptoms, including chronic pain. Many studies have identified a variety of conservative interventions, such as physical therapy, for patients with temporomandibular joint disorders, including joint mobilization, tissue mobilization,dry needling, friction massage, patient education, splints, modalities, stretching, coordination activities,strengthening exercises, and combinations of these techniques. postoperative major complications such as pain, edema and trismus in various oral surgeries such as tooth extraction, maxillary expansion, and orthognathic surgeries. Oral surgical procedures are often accompanied by a multitude of complications including pain, swelling, and morbidity. These are the result of inflammatory processes induced by the surgical wound healing.
Facial edema: During surgeries, inflammatory chemicals such as prostaglandins, leukotrienes, bradykinins, and platelet-activation factors are secreted by damaged tissue. Moreover, excessive lymph production causes disturbances in local lymphatic circulation. Inflammatory chemicals create endothelial gaps to increase vascular permeability. In addition, macrophages and mast cells in damaged tissues produce histamine, serotonin, and eicosanoids; alter the local constitution of blood vessels; and release nitric oxide, eventually resulting in vasorelaxation. These chain reactions increase blood vessel relaxation and vascular permeability and result in the accumulation of interstitial fluid, eventually resulting in tissue swelling and pain.
Trismus: It is defined as prolonged tetanic spasm of masticatory muscles of jaw. the transient jaw stiffness usually reaches its peak on the 2nd day post surgery. It is diagnosed from clinical examination of the maximal interincisal distance (MID) <40-45 mm caused by contracture and not by obstructive joint impingement.The factors contributing to trismus are: (1) Multiple needle penetrations correlate with a greater incidence of post injection trismus. (2) Elevation of flap beyond the external oblique ridge. (3) At times, the patient hurts his/her own tongue or cheek under the effect of anesthesia resulting in reflex trismus.
kinesio taping (KT) was developed by the Japanese therapist and academic lecturer. More than 30 years ago, he created a special tape, which by the correct application, i.e. sticking with a small stretch (about 15%) to the skin, raises the surface of the skin, thereby increasing the space between the dermis and fascia . The expansion of this space, should reduce lymph retention. The patch used for this method has a thickness and weight similar to skin. The waterproof tape is made of 100% cotton, while the adhesive on the inside is applied in the shape of a fan strip, which allows the air to flow. When stretched beyond its normal length and applied, it recoils and creates a pulling force on the skin, thus improving blood and lymph flow by alleviating hemorrhage and congestion of lymphatic fluid.
Manual therapy (MT) is one of the various types of interventions for treating patients with temporomandibular joint dysfunction and include: Mobilization exercise stretching exercise, coordination exercise, rang of motion exercise and strengthening exercise. Within other body regions, manual therapy intervention has been detailed and summarize the efficacy of treatment approaches.Strengthening, stretching/flexibility, and motor control exercises have demonstrated to be efficacious in reducing pain and disability in patients with chronic low back pain,as well as mechanical neck pain. Despite a review and meta-analysis the efficacy of exercise therapy and dosage has yet to be determined for patients with temporomandibular joint dysfunction. exercises intended to increase mobility of the temporomandibular joint and/or muscles of the jaw. Exercise therapy aims to reduce clinical symptoms such as pain in the muscles and joints, and improve motor function by moving whole or part of the body.Exercise can be classified into self exercise by patients and manual therapy that physiotherapists apply to patients. Self exercise is often offered as home exercise or self-care program that can be done at home. manual exercise therapy includes mobilization, stretch,muscle strengthening exercise and coordination exercise.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Giza
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Cairo, Giza, Egypt, 3753450
- Faculty of physical therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age ranged between 20-50 years
- both gender
- TMJ dysfunction following oral surgeries.
Exclusion Criteria:
- open wound in affected area
- facial trauma,smoker and infection
- sensitivity to tape
- allergies to medication administered in the study
- reluctance to shave facial hair (for men)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group
patients who will receive manual therapy and Kinesio taping, in additional to basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ) 3 times per week for two weeks.
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Skin-colored Kinesiology Tape (ARES tape,5 cm×5 m) is waterproof tape is made of 100% cotton,applied in the shape of a fan strip, waterproof.
The width is 5 cm and thickness of 0.5 mm (5 cm×5 m ).This tape is sticking with a small stretch (about 15%).
Place gauze pack over surgical site for one hour after surgery.
Ice packs will be applied for 6 hours after surgery in all patients
passive and active range of motion, stretching exercises, resistive mouth exercises, mobilization exercises and coordination exercices.
Other Names:
NSAIDs like ibuprofen (600-800 mg) or declophenac sodium (50-150 mg) 3 times a day
1-2 ampoules daily IM box of 3 ampoules of 5 mg crystallized and lyophilized chymotrypsin (450 E. A. Units) + 3 ampoules of 3 ml apyrogenic saline for one week.
use 0.12% chlorhexidine or povidone iodine mouthwash daily
For the day of surgery
|
Placebo Comparator: Control group
patients who will receive basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ).
|
Place gauze pack over surgical site for one hour after surgery.
Ice packs will be applied for 6 hours after surgery in all patients
NSAIDs like ibuprofen (600-800 mg) or declophenac sodium (50-150 mg) 3 times a day
1-2 ampoules daily IM box of 3 ampoules of 5 mg crystallized and lyophilized chymotrypsin (450 E. A. Units) + 3 ampoules of 3 ml apyrogenic saline for one week.
use 0.12% chlorhexidine or povidone iodine mouthwash daily
For the day of surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
facial swelling
Time Frame: Two weeks
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Facial swelling was assessed by a four-line measurement method using a flexible plastic tape measure.
The corresponding lines were line A from the most posterior point of the tragus to the most lateral point of the lip commissure),line B (from the most posterior point of the tragus to the pogonion), line C from the most inferior point of the mandibular angle to lateral canthus of the eye ; and line D, most inferior point of the mandibular angle to (the nasal border - wing of the nostril.
These measurements were performed with the patient sitting at 90° straight position with physiologic rest position of the mandible.
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Two weeks
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Facial pain
Time Frame: Two weeks
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Visual analogue scale (VAS)measure, consists of a line usually 10 cm in length, with anchor descriptors such as (in the pain context) where 0 means no pain and 10 means worst conceivable pain.
patients asked to mark the point corresponding to the intensity of their pain , and the distance from the left endpoint to the mark is measured, in cm.
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Two weeks
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Maximum mouth opening
Time Frame: Two weeks
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measurement of maximal interincisal distance (mm) attained during the active mouth opening by the subject.
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Two weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Lietz-Kijak D, Kijak E, Krajczy M, Bogacz K, Luniewski J, Szczegielniak J. The Impact of the Use of Kinesio Taping Method on the Reduction of Swelling in Patients After Orthognathic Surgery: A Pilot Study. Med Sci Monit. 2018 Jun 4;24:3736-3743. doi: 10.12659/MSM.909915.
- Yurttutan ME, Sancak KT. The effect of kinesio taping with the web strip technique on pain, edema, and trismus after impacted mandibular third molar surgery. Niger J Clin Pract. 2020 Sep;23(9):1260-1265. doi: 10.4103/njcp.njcp_23_20.
- Jaron A, Preuss O, Grzywacz E, Trybek G. The Impact of Using Kinesio Tape on Non-Infectious Complications after Impacted Mandibular Third Molar Surgery. Int J Environ Res Public Health. 2021 Jan 6;18(2):399. doi: 10.3390/ijerph18020399.
- Tatli U, Benlidayi IC, Salimov F, Guzel R. Effectiveness of kinesio taping on postoperative morbidity after impacted mandibular third molar surgery: a prospective, randomized, placebo-controlled clinical study. J Appl Oral Sci. 2020;28:e20200159. doi: 10.1590/1678-7757-2020-0159. Epub 2020 Jul 13.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Muscular Diseases
- Stomatognathic Diseases
- Jaw Diseases
- Craniomandibular Disorders
- Mandibular Diseases
- Myofascial Pain Syndromes
- Joint Diseases
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Analgesics
Other Study ID Numbers
- Kinesiotaping effect on TMJ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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