- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
El-Sharqia Governorate
-
Abū Ḩammād, El-Sharqia Governorate, Egypten
- Abu Hammad General Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
|
Eksperimentel: 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).
|
|
Aktiv komparator: 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);
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain intensity level
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum Interincisal Opening
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 000000 (MRDC)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Postoperative Trismus
-
Medipol UniversityRekrutteringPostoperativ smerte | Trismus | Postoperativt ødem | Ortognatisk kirurgiKalkun
-
Harran UniversityRekrutteringPostoperative komplikationer | Postoperativ smerte | Trismus | Periodontal sundhedTyrkiet (Türkiye)
-
Konya Necmettin Erbakan ÜniversitesiAfsluttetØdem | Postoperativ smerte | Trismus | Påvirket mandibular tredje molarTyrkiet (Türkiye)
-
Ankara UniversityAfsluttetPostoperativ smerte | Trismus | Hævelse i ansigtet | Påvirket mandibular tredje molarTyrkiet (Türkiye)
-
Al Salam UniversityAktiv, ikke rekrutterendePostoperativ smerte | Trismus | Hævelse i ansigtet | Påvirket mandibular tredje molarEgypten
-
Dow University of Health SciencesAfsluttetSmerter, postoperativ | Trismus | Healing af blødt væv | Postoperativ hævelsePakistan
-
Universidad de GranadaAfsluttetBetændelse | Smerter, postoperativ | TrismusSpanien
-
Oman Medical Speciality BoardRekrutteringPostoperativ smerte | Trismus | Hævelse i ansigtetOman
-
Afyonkarahisar Health Sciences UniversityAfsluttetSmerter, postoperativ | Trismus | Ødem ansigt | VisdomstandKalkun
-
Hayat Abad Medical Complex, PeshawarIkke rekrutterer endnuPostoperativ smerte | Trismus | Påvirket mandibular tredje molar
Kliniske forsøg med Maitland Joint Mobilization
-
Riphah International UniversityIkke rekrutterer endnuLændesmerter | Spinal stenosePakistan
-
Foundation University IslamabadRekrutteringSacral TorsionPakistan
-
Riphah International UniversityAfsluttetKlæbende kapsulitis af skulderPakistan
-
Foundation University IslamabadRekrutteringTemporomandibulær leddysfunktionPakistan
-
Bahçeşehir UniversityAfsluttetBasketballspillere | Mobilisering | Springende præstationKalkun
-
Cairo UniversityAfsluttet
-
Foundation University IslamabadAktiv, ikke rekrutterende
-
Prince Sattam Bin Abdulaziz UniversityAfsluttet
-
University of LahoreAfsluttetNakke smerter | Mekanisk nakkesmerter | Mobilisering | Nakkesmerter Muskuloskeletale | Proprioceptiv neuromuskulær faciliteringPakistan
-
Riphah International UniversityIkke rekrutterer endnuPlantar fascitis | HælsmertesyndromPakistan