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Manual Therapy and Kinesio Taping on Temporomandibular Joint Dysfunction Following Oral Surgeries

Primary Purpose

Temporomandibular Joint Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Kinesio tape
Gauze pack
ice pack
Manual therapy
Analgesic
Proteolytic enzymes
Mouth wash
Soft cold diet
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Dysfunction focused on measuring Kinesio taping, Manual therapy, Oral surgeries

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Faculty of physical therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study group

Control group

Arm Description

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.

patients who will receive basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ).

Outcomes

Primary Outcome Measures

facial swelling
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.
Facial pain
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.
Maximum mouth opening
measurement of maximal interincisal distance (mm) attained during the active mouth opening by the subject.

Secondary Outcome Measures

Full Information

First Posted
June 10, 2022
Last Updated
December 10, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05422703
Brief Title
Manual Therapy and Kinesio Taping on Temporomandibular Joint Dysfunction Following Oral Surgeries
Official Title
Combined Effect of Manual Therapy and Kinesio Taping on Temporomandibular Joint Dysfunction Following Oral Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
June 18, 2022 (Actual)
Study Completion Date
August 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Oral surgeries include various types such as impacted wisdom tooth surgery, oral cyst enucleation (cystectomy), surgical incision and drainage of odontogenic abcess, oral tumor excision and open reduction and internal fixation of mandibular fracture (ORIF). Oral surgeries are usually associated with pain, swelling and inability to open the mouth. Those symptoms reach the maximum intensity between the third to fifth days postoperatively for the swelling and 24 to 48 hours postoperatively for the pain and then, they gradually diminished until the 7th day postoperatively
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Dysfunction
Keywords
Kinesio taping, Manual therapy, Oral surgeries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
patients who will receive basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ).
Intervention Type
Device
Intervention Name(s)
Kinesio tape
Intervention Description
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%).
Intervention Type
Other
Intervention Name(s)
Gauze pack
Intervention Description
Place gauze pack over surgical site for one hour after surgery.
Intervention Type
Device
Intervention Name(s)
ice pack
Intervention Description
Ice packs will be applied for 6 hours after surgery in all patients
Intervention Type
Procedure
Intervention Name(s)
Manual therapy
Other Intervention Name(s)
Exercises
Intervention Description
passive and active range of motion, stretching exercises, resistive mouth exercises, mobilization exercises and coordination exercices.
Intervention Type
Drug
Intervention Name(s)
Analgesic
Intervention Description
NSAIDs like ibuprofen (600-800 mg) or declophenac sodium (50-150 mg) 3 times a day
Intervention Type
Drug
Intervention Name(s)
Proteolytic enzymes
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Mouth wash
Intervention Description
use 0.12% chlorhexidine or povidone iodine mouthwash daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Soft cold diet
Intervention Description
For the day of surgery
Primary Outcome Measure Information:
Title
facial swelling
Description
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.
Time Frame
Two weeks
Title
Facial pain
Description
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.
Time Frame
Two weeks
Title
Maximum mouth opening
Description
measurement of maximal interincisal distance (mm) attained during the active mouth opening by the subject.
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Faculty of physical therapy
City
Cairo
State/Province
Giza
ZIP/Postal Code
3753450
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29861496
Citation
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.
Results Reference
background
PubMed Identifier
32913166
Citation
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.
Results Reference
background
PubMed Identifier
33419167
Citation
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.
Results Reference
background
PubMed Identifier
32667383
Citation
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.
Results Reference
background

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Manual Therapy and Kinesio Taping on Temporomandibular Joint Dysfunction Following Oral Surgeries

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