Clinical trial NCT04376190: Effect of Low Level Laser Therapy on the Temporomandibular Joint During Treatment of Skeletal Class II Malocclusion
Official title: Three-dimensional Judgment of Mandibular Condylar Volume and Position Subsequent to Twin-block Functional Therapy of Skeletal Class II Malocclusion Accompanied With Low-level Laser Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion Class II
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 24
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: laser group and control group
Primary purpose: TREATMENT

Brief summary: to evaluate effect of low-level laser therapy (LLLT) on mandibular condylar volume and position after treatment of Class II malocclusion with Twin Block (TB) functional therapy via cone beam computed tomography (CBCT).

Materials and methods: Twenty eight growing patients, 14 boys and 14 girls ranged in age 9-12 years, were randomly divided into control group (mean initial age 10.64±1.36 years) and laser group (mean initial age 10.55 1.45 years). All patients treated with TB appliance where Gallium aluminum arsenide diode laser applied in one group weekly around TMJ region for 12 sessions in three months with set parameters: continuous 635 nm, 50 mW, 4.5J/cm2, 45 seconds/ point, total dose per side 11.25J. CBCT were obtained before and immediately after TB therapy, in addition to routine orthodontic records. Changes in TMJ and skeletal variables were analyzed and compared within and between both groups.

Detailed description: to evaluate the effect of low-level laser therapy (LLLT) on mandibular condylar volume and position after treatment of Class II malocclusion with Twin Block (TB) functional therapy via cone-beam computed tomography (CBCT).

Materials and methods: Twenty-eight growing patients, 14 boys, and 14 girls ranged in age 9-12 years, were randomly divided into control group (mean initial age 10.64±1.36 years), and laser group (mean initial age 10.55 1.45 years). All patients treated with TB appliance where Gallium aluminum arsenide diode laser applied in one group weekly around TMJ region for 12 sessions in three months with set parameters: continuous 635 nm, 50 mW, 4.5J/cm2, 45 seconds/ point, total dose per side 11.25J. CBCT were obtained before and immediately after TB therapy, in addition to routine orthodontic records. Changes in TMJ and skeletal variables were analyzed and compared within and between both groups.

Eligibility criteria: Inclusion Criteria:

* Skeletal Class II (ANB°\> 5°) with the normal maxilla (SNA°=82°±4°) and retrognathic mandible (SNB°\< 78°).
* Overjet greater than 5 mm.
* Minimal crowding in dental arches (≤ 3 mm).
* The lower incisors should be on average inclination or slightly retroclined.
* All the patients were in stages II and III based on the modified cervical vertebral maturation stages(CVMS) according to Bacetti et al.

Exclusion Criteria:

* Previous history of orthodontic treatment.
* Congenitally missing or extracted permanent tooth (except third molars).
* Posterior crossbites or severe maxillary transverse deficiency.
* Severe facial asymmetry determined by clinical or radiographic examination.
* Poor oral hygiene.
* Systemic diseases that may affect orthodontic treatment results.

Primary outcomes:
measure: Changes of condylar volume (mm3) and condylar head position before and after Twin-block therapy with and without LLLT:
timeFrame: after 9 mouth from starting treatment
Secondary outcomes:
measure: Changes of cephalometric skeletal measurements before and after Twin-block therapy with and without LLLT
timeFrame: after 9 mouth from starting treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dental Medicine (Boys), Al- Azhar University,
state: Cairo Nasr City
Study officials:
affiliation: Al-Azhar University
name: Mahmoud A Mohamed, MSc student
role: PRINCIPAL_INVESTIGATOR
References: