Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353724
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2024-03-20
Brief Title:
Comparison Between the Effect of Using Conventional and Digital Oral Positional Radiation Stent
Sponsor:
Tanta University
Organization:
Tanta University
Study Overview
Official Title:
Comparison Between the Effect of Using Conventional and Digital Oral Positional Radiation Stent on Healthy Tissues Salivary PH
Status:
COMPLETED
Status Verified Date:
2024-04
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:
stent
Brief Summary:
The goal of this clinical trial is to compare between the Effect of Using Conventional and Digital Oral Positional Radiation Stent on Healthy tissues salivary PH The main question it aims to answer are Does the difference in manufacturing method affect on Healthy tissues salivary PH
Participants will use radiation positioning stent during radiotherapy sessions Two groups will be compared
Group A OPRS was constructed according to the conventional technique
Group B OPRS was constructed digitally using CAD CAM technology to evaluate Dosimetric analysis to quantify the radiation dose in OARs PH of saliva measurement and Mucositis assessment
Participants will use radiation positioning stent during radiotherapy sessions Two groups will be compared
Group A OPRS was constructed according to the conventional technique
Group B OPRS was constructed digitally using CAD CAM technology to evaluate Dosimetric analysis to quantify the radiation dose in OARs PH of saliva measurement and Mucositis assessment
Detailed Description:
This study will be a clinically prospective study that will include 16 patients with head and neck cancer This study will be carried out at the Clinical Prosthodontics Department Clinical Oncology Department of Tanta University
Informed consent will be obtained from all patients with maintenance of their privacy prior to inclusion in the study according to the guidelines on human research adopted by the Research Ethics Committee Faculty of Dentistry Tanta University
Patients evaluation
All patients will be subjected to the following protocol
Oral examination Clinical dental evaluation intraoral photography and mouth opening measurements
Grouping The patients will be divided randomly into 2 groups each group consists of 8 patients according to the technique that will be used for construction
First group The OPRS will be constructed according to the conventional technique27
Second group The OPRS will be constructed digitally according to the following steps
Intraoral scanning It will be done using an intraoral scanner to generate three 3D images the first of the superior arch the second of the inferior arch and the third of the maximum habitual intercuspation Images will be compiled into a 3D file system
Oral positioning radiation stent design The compiled file will be exported into Exocad software which is smart software for dental design on digital models for stent design and by using a virtual articulator
3D printing After optimizing the digital file 3D printing will be performed The oral positioning radiation stent will be printed using the 3D printer Resin Printing Material
For both groups
Insertion making the necessary adjustment will be done
RT techniques and dose distributions
All patients will be referred to the RT department for IMRT planning During the pre-irradiation simulation the intraoral stents will be placed and the patients will be immobilized by individual thermoplastic masks A computed tomography scan will be conducted to determine the precise planning target volume PTV all patients will be scanned using the positional prosthesis once and without it
Dosimetric analysis
To quantify the radiation dose in the structures the maxilla area of the teeth both parotid glands ipsilateral and contralateral the mandible and the PTV will be defined and contoured in computed tomography pre-irradiation planning The mean corresponding dose of each structure will be acquired using a dose-volume histogram
All patients will complete the radiotherapy sessions using the positional radiation prosthesis together with the extra oral immobilization masks
Mucositis assessment
The severity of mucositis will be assessed weekly from the beginning of RT to the end of the treatment mean time 7 weeks It will be scored in accordance with the classification criteria of the National Cancer Institute
PH of saliva measurement
A saliva sample will be collected from each patient to measure salivary PH by digital PH meter 19 before the beginning of radiotherapy and the measurement will be continued weekly until the end of the treatment
Informed consent will be obtained from all patients with maintenance of their privacy prior to inclusion in the study according to the guidelines on human research adopted by the Research Ethics Committee Faculty of Dentistry Tanta University
Patients evaluation
All patients will be subjected to the following protocol
Oral examination Clinical dental evaluation intraoral photography and mouth opening measurements
Grouping The patients will be divided randomly into 2 groups each group consists of 8 patients according to the technique that will be used for construction
First group The OPRS will be constructed according to the conventional technique27
Second group The OPRS will be constructed digitally according to the following steps
Intraoral scanning It will be done using an intraoral scanner to generate three 3D images the first of the superior arch the second of the inferior arch and the third of the maximum habitual intercuspation Images will be compiled into a 3D file system
Oral positioning radiation stent design The compiled file will be exported into Exocad software which is smart software for dental design on digital models for stent design and by using a virtual articulator
3D printing After optimizing the digital file 3D printing will be performed The oral positioning radiation stent will be printed using the 3D printer Resin Printing Material
For both groups
Insertion making the necessary adjustment will be done
RT techniques and dose distributions
All patients will be referred to the RT department for IMRT planning During the pre-irradiation simulation the intraoral stents will be placed and the patients will be immobilized by individual thermoplastic masks A computed tomography scan will be conducted to determine the precise planning target volume PTV all patients will be scanned using the positional prosthesis once and without it
Dosimetric analysis
To quantify the radiation dose in the structures the maxilla area of the teeth both parotid glands ipsilateral and contralateral the mandible and the PTV will be defined and contoured in computed tomography pre-irradiation planning The mean corresponding dose of each structure will be acquired using a dose-volume histogram
All patients will complete the radiotherapy sessions using the positional radiation prosthesis together with the extra oral immobilization masks
Mucositis assessment
The severity of mucositis will be assessed weekly from the beginning of RT to the end of the treatment mean time 7 weeks It will be scored in accordance with the classification criteria of the National Cancer Institute
PH of saliva measurement
A saliva sample will be collected from each patient to measure salivary PH by digital PH meter 19 before the beginning of radiotherapy and the measurement will be continued weekly until the end of the treatment
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