Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413628
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2024-03-19
Brief Title:
Efficiency of Different Treatment Modalities on Radiation Induced Trismus for Maxillofacial Patients
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Efficiency of Different Treatment Modalities on Radiation Induced Trismus for Maxillofacial Cases
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim to compare different treatment modalities for radiation induced trismus for maxillofacial patients methods45 participants 20 females and 25 males with trismus and pain following head and neck cancer and underwent radiation therapy were enrolled in this study patients were divided into three groups group1 received threaded tapered screw appliance therapy patients in group II received low-level laser therapy and patients in group III received low-level laser therapy in addition to threaded tapered screw appliance therapy
Detailed Description:
All patients received treatment according to their group For group I received threaded tapered screw appliance therapy The appliance was digitally designed by solid works programs for 3rd CAD design software to obtain the STL file format The virtual design of was approved The printer was loaded with material of 3D-printed denture base The appliance was printed
For group II received low-level laser therapy the laser type was of diode laserThe laser apparatus consisted of a hand piece with two attachments either a plastic tip was attached to the same hand piece to transfer laser energy intro-orally when it was used to irradiate the lateral pterygoid muscle or a specially designed optic prism was attached to the tip of the prism for extraoral application on extra oral muscles All patients in this group received low level laser therapy twice times a week for 6 weeks totaling 12 sessions In each session the laser beam was applied in a three phases treatment protocol as follows a The insertion of the lateral pterygoid muscle into the condylar neck and disc was treated in the first phase by applying a laser beam 1 cm anterior to the condyle below the zygomatic arch b Tender spots in the masseter and temporalis muscles that were found during the initial assessment were exposed to radiation during the second phase c The lateral pterygoid muscle origin was exposed to radiation in the third phase which was performed with the mouth slightly open and intro-orally posterior to the final molar During each phase the laser was operated for two minutes per area at a wavelength of 810 nm and a peak output of 500 mW It was applied continuously a little distance away from the tissues The laser probe was positioned perpendicular to the target area Prior to usage the laser was calibrated Protective glasses were worn by the clinician and the patients For group III received low-level laser therapy in addition to threaded tapered screw appliance therapy as mentioned previously in group I and group II Concurrent with the initial low level laser therapy session screw tapered appliance was used for the first time
Throughout the trial no medication was administered to any of the groups The patients were not allowed to use any painkillers or analgesics
For group II received low-level laser therapy the laser type was of diode laserThe laser apparatus consisted of a hand piece with two attachments either a plastic tip was attached to the same hand piece to transfer laser energy intro-orally when it was used to irradiate the lateral pterygoid muscle or a specially designed optic prism was attached to the tip of the prism for extraoral application on extra oral muscles All patients in this group received low level laser therapy twice times a week for 6 weeks totaling 12 sessions In each session the laser beam was applied in a three phases treatment protocol as follows a The insertion of the lateral pterygoid muscle into the condylar neck and disc was treated in the first phase by applying a laser beam 1 cm anterior to the condyle below the zygomatic arch b Tender spots in the masseter and temporalis muscles that were found during the initial assessment were exposed to radiation during the second phase c The lateral pterygoid muscle origin was exposed to radiation in the third phase which was performed with the mouth slightly open and intro-orally posterior to the final molar During each phase the laser was operated for two minutes per area at a wavelength of 810 nm and a peak output of 500 mW It was applied continuously a little distance away from the tissues The laser probe was positioned perpendicular to the target area Prior to usage the laser was calibrated Protective glasses were worn by the clinician and the patients For group III received low-level laser therapy in addition to threaded tapered screw appliance therapy as mentioned previously in group I and group II Concurrent with the initial low level laser therapy session screw tapered appliance was used for the first time
Throughout the trial no medication was administered to any of the groups The patients were not allowed to use any painkillers or analgesics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None