NCT05422703

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2022

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2022

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

June 10, 2022

Last Update Submit

May 16, 2025

Conditions

Keywords

Kinesio tapingManual therapyOral surgeries

Outcome Measures

Primary Outcomes (3)

  • 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.

    Two weeks

  • 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.

    Two weeks

  • Maximum mouth opening

    measurement of maximal interincisal distance (mm) attained during the active mouth opening by the subject.

    Two weeks

Study Arms (2)

Study group

EXPERIMENTAL

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.

Device: Kinesio tapeOther: Gauze packDevice: ice packProcedure: Manual therapyDrug: AnalgesicDrug: Proteolytic enzymesDrug: Mouth washDietary Supplement: Soft cold diet

Control group

PLACEBO COMPARATOR

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

Other: Gauze packDevice: ice packDrug: AnalgesicDrug: Proteolytic enzymesDrug: Mouth washDietary Supplement: Soft cold diet

Interventions

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%).

Study group

Place gauze pack over surgical site for one hour after surgery.

Control groupStudy group
ice packDEVICE

Ice packs will be applied for 6 hours after surgery in all patients

Control groupStudy group

passive and active range of motion, stretching exercises, resistive mouth exercises, mobilization exercises and coordination exercices.

Also known as: Exercises
Study group

NSAIDs like ibuprofen (600-800 mg) or declophenac sodium (50-150 mg) 3 times a day

Control groupStudy group

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.

Control groupStudy group

use 0.12% chlorhexidine or povidone iodine mouthwash daily

Control groupStudy group
Soft cold dietDIETARY_SUPPLEMENT

For the day of surgery

Control groupStudy group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age ranged between 20-50 years
  • both gender
  • TMJ dysfunction following oral surgeries.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Cairo, Giza Governorate, 3753450, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 29861496BACKGROUND
  • 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.

    PMID: 32913166BACKGROUND
  • 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.

    PMID: 33419167BACKGROUND
  • 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.

    PMID: 32667383BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Athletic TapeMusculoskeletal ManipulationsExerciseAnalgesicsPeptide HydrolasesMouthwashes

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical EquipmentComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic UsesHydrolasesEnzymesEnzymes and CoenzymesBiomedical and Dental MaterialsSpecialty Uses of ChemicalsCosmeticsManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Combined effect of manual therapy and kinesiotaping on temporomandibular joint dysfunction following oral surgeries

Study Record Dates

First Submitted

June 10, 2022

First Posted

June 16, 2022

Study Start

January 15, 2022

Primary Completion

June 18, 2022

Study Completion

August 18, 2022

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations