- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07575100
Maitland Mobilization Versus Therapeutic Ultrasound on Trismus Following Third Molar Surgery
Effect of Maitland Mobilization Versus Therapeutic Ultrasound on Trismus Following Third Molar Surgery
This study aims to compare the effect of Maitland mobilization and therapeutic ultrasound on trismus (limited mouth opening) following third molar (wisdom tooth) surgery.
Participants who experience limited mouth opening after third molar surgery will receive one of two treatment methods: Maitland joint mobilization or therapeutic ultrasound. These treatments are commonly used in physical therapy to improve jaw movement and reduce stiffness.
The purpose of this study is to determine which treatment is more effective in improving mouth opening and reducing symptoms after surgery.
Participation is voluntary, and all collected information will be kept confidential and used only for research purposes.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This randomized clinical study will investigate the effect of Maitland mobilization compared to therapeutic ultrasound on trismus following third molar (wisdom tooth) surgery.
Trismus, characterized by limited mouth opening, is a common postoperative complication after third molar extraction and can affect oral function and quality of life All patients of both groups received Standard Postoperative Care designed to promote natural recovery after third molar surgery. The standard care protocol includes the use of Cold Compresses/Ice Packs, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), basic jaw exercises at home to prevent further restriction of jaw movement.
Group A Maitland Mobilization group: Participants received Maitland mobilization therapy. The manual therapy involved graded oscillatory movements targeting the temporomandibular joint (TMJ), aimed at improving jaw mobility and reducing pain following third molar surgery. Each therapy session lasted approximately 15-20 minutes and was conducted three times a week over a period of four weeks. During each session, the physiotherapist applied different grades of mobilization depending on the patient's progress. Grade I and II movements-small, rhythmic oscillations-were used initially to reduce pain and relax the muscles. As the treatment progressed, Grade III and IV mobilizations were applied to stretch the joint capsule and further improve range of motion. Additionally, patients were instructed to perform home exercises to maintain the therapeutic gains between sessions, such as gentle jaw stretching and mouth-opening exercises .
Group B (Therapeutic Ultrasound group): The procedure involved using an ultrasound device , such as the Chattanooga Intelect Mobile 2, which operates at a 1 MHz frequency to target deep tissues like the temporomandibular joint (TMJ) and surrounding muscles. The therapy was conducted three times a week for four weeks, with each session lasting 10-15 minutes. A water-based conductive gel was applied to the skin to facilitate effective transmission of sound waves, and the intensity of the ultrasound was adjusted between 0.8 to 1.5 W/cm² based on patient tolerance. The transducer was moved in slow, circular motions over the TMJ and affected muscles, focusing on areas of pain or stiffness. Group C (Control group ): received traditional physical therapy program only. The outcomes measured included Maximum Interincisal Opening (MIO) via a Vernier Caliper. MIO was measured as the primary indicator of jaw mobility in patients experiencing postoperative trismus. MIO is the distance between the upper and lower central incisors when the patient opens their mouth fully, with the patient seated comfortably and properly supported. The MIO was recorded at baseline (before the intervention) and again at the end of the 4-week intervention period. Each measurement was repeated three times to ensure accuracy, with the average of the three readings used as the final recorded value. This process allows for consistent and precise tracking of improvements in jaw mobility over time.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
El-Sharqia Governorate
-
Abū Ḩammād, El-Sharqia Governorate, Egypte
- Abu Hammad General Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
Patients were included in this study have the following criteria
- Sixty patients had done third molar extraction surgery
- Patients suffering from postoperative trismus within 2 to 14 days post-surgery.
- Their age between 20 and 30 years old
- All patients are medically and clinically stable when attending the study 2.1.2. Exclusion criteria:
The study excluded the following patients:
- Pre-existing TMJ Disorders: Patients with a history of temporomandibular joint (TMJ) disorders or jaw-related conditions (e.g., TMJ dislocation, arthritis, or previous TMJ surgery).
- Neurological or Muscular Disorders: (e.g., facial palsy, stroke, muscular dystrophy).
- Previous Jaw Surgery or Trauma.
- Use of Muscle Relaxants or other form of Physical Therapy treatment.
- Chronic Pain Syndromes: such as fibromyalgia or chronic migraines
- Infections or abscesses post-Surgery.
- Patients have auditory and visual problems
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Maitland Mobilization Group
Participants in this group received Maitland mobilization techniques applied to the temporomandibular joint.
The intervention was performed by a trained therapist using graded passive mobilization techniques aimed at improving joint mobility and reducing trismus.
Treatment sessions were conducted over the study period with standardized frequency and duration
|
Maitland mobilization was applied to the temporomandibular joint using graded passive accessory and physiological joint mobilization techniques (Grade I-IV depending on patient tolerance).
The technique was performed by a trained physical therapist to improve joint mobility and reduce trismus following third molar surgery.
Treatment sessions were conducted three times per week for four weeks
|
|
Experimenteel: Therapeutic Ultrasound group
Participants received therapeutic ultrasound applied to the temporomandibular joint and surrounding muscles.
The ultrasound was delivered at a frequency of 1 MHz to target deep tissues.
Treatment sessions were conducted three times per week for four weeks, with each session lasting 10-15 minutes.
A water-based conductive gel was applied to enhance transmission of sound waves.
The intensity ranged from 0.8 to 1.5 W/cm² based on patient tolerance, and the transducer was moved in slow circular motions over the affected area to reduce pain and stiffness
|
using an ultrasound device , such as the Chattanooga Intelect Mobile 2, which operates at a 1 MHz frequency to target deep tissues like the temporomandibular joint (TMJ) and surrounding muscles.
The therapy was conducted three times a week for four weeks, with each session lasting 10-15 minutes.
A water-based conductive gel was applied to the skin to facilitate effective transmission of sound waves, and the intensity of the ultrasound was adjusted between 0.8 to 1.5 W/cm² based on patient tolerance.
The transducer was moved in slow, circular motions over the TMJ and affected muscles, focusing on areas of pain or stiffness (Bhushan et al., 2025).
|
|
Actieve vergelijker: Control group
traditional physical therapy program (Standard Postoperative Care, Cold Compresses/Ice Packs, NSAIDs);
|
the traditional physical therapy program (Standard Postoperative Care, Cold Compresses/Ice acks, NSAIDs);
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pain intensity level
Tijdsspanne: Baseline, immediately post-intervention
|
Pain intensity level via The Visual Analog Scale (VAS): The VAS is self-completed by the participant. The participant is asked to place a line perpendicular to the VAS 100 mm line at the point that represents their pain intensity. The examiner reported the VAS score by measuring the distance (mm) from the marked point to the "no pain" anchor using a ruler, providing a range of scores from 0 -100 (Boonstra et al., 2008) |
Baseline, immediately post-intervention
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Maximum Interincisal Opening
Tijdsspanne: Baseline, immediately post-intervention
|
Maximum Interincisal Opening (MIO) via a digital caliper: The maximum interincisal opening (MIO) measured as the primary indicator of jaw mobility in patients experiencing postoperative trismus. MIO is the distance between the upper and lower central incisors when the patient opens their mouth fully. The measurement taken using a digital caliper, with the patient seated comfortably and properly supported. The MIO will be recorded at baseline (before the intervention) and again at the end of the 4-week intervention period. Each measurement repeated three times to ensure accuracy, with the average of the three readings used as the final recorded value. This process allow for consistent and precise tracking of improvements in jaw mobility over time (Buesa-Bárez et al., 2018). |
Baseline, immediately post-intervention
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 000000 (MRDC)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Postoperative Trismus
-
Sharif Medical Research CenterVoltooid
-
Federal University of the Valleys of Jequitinhonha...VoltooidEffect van dexamethason en methylprednisolon op pijn, zwelling en trismus na derde molaire chirurgieTrismus | Pijn, | Oedeem,Brazilië
-
Assistance Publique - Hôpitaux de ParisNog niet aan het werven
-
Foundation University IslamabadActief, niet wervend
-
Watim Medical & Dental CollegeNog niet aan het werven
-
Mansoura UniversityVoltooid
-
Cairo UniversityWerving
-
Erzincan UniversityOnbekendImpact van preventieve intraveneuze ibuprofen op postoperatief oedeem en trismus in de derde molarenOedeem | TrismusKalkoen
-
University of Medicine and Pharmacy at Ho Chi Minh...VoltooidPijn | Trismus | Zwelling | Derde kiesextractieoperatie | KINESIOTAPINGVietnam
-
Federal University of the Valleys of Jequitinhonha...VoltooidPijn | Oedeem | TrismusBrazilië
Klinische onderzoeken op Maitland Joint Mobilization
-
Riphah International UniversityNog niet aan het wervenOnderrug pijn | WervelkanaalstenosePakistan
-
Prince Sattam Bin Abdulaziz UniversityVoltooidTennis elleboogSaoedi-Arabië
-
Foundation University IslamabadWerving
-
Cairo UniversityAanmelden op uitnodigingCervicogene hoofdpijn | Nekpijn MusculoskeletaalEgypte
-
Palestine Polytechnic UniversityVoltooidTemporomandibulaire aandoeningen (TMD)Palestijns gebied, bezet
-
Alabama Physical Therapy & AcupunctureUniversidad Rey Juan CarlosWervingSpanningshoofdpijnVerenigde Staten
-
Lipo-SphereVoltooid
-
Riphah International UniversityNog niet aan het wervenFasciitis plantaris | HielpijnsyndroomPakistan
-
Centre for Interdisciplinary Research in Rehabilitation...Jewish General HospitalNog niet aan het werven
-
Huazhong University of Science and TechnologyBeijing Friendship Hospital; Qilu Hospital of Shandong University; Sir Run Run... en andere medewerkersNog niet aan het wervenAlvleesklierkanker | Pancreatitis | Auto-immuun pancreatitis | Solide pseudo-apillair neoplasma van de pancreas | Pancreatische neuro-endocine neoplasmata (pNET's)China