Radiotherapy Side EffectstentNCT06353724
Comparison Between the Effect of Using Conventional and Digital Oral Positional Radiation Stent
A study testing conventional oral positioning stent were used during radiation planning and the PTV will be defined and contoured in computed tomography pre irradiation planning and Digital positioning stent in people with Radiotherapy Side Effect, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Radiotherapy Side Effect
- What is being tested?
- conventional oral positioning stent were used during radiation planning and the PTV will be defined and contoured in computed tomography pre irradiation planning and Digital positioning stent
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Oct 2019to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Limit of age was between 20 -40 years old.
- Inter-arch distance ≥ 1.5 cm
- Good oral hygiene.
Who cannot join
- Patients with conditions that limited the construction of the stent (e.g. gross tumor block most of the oral cavity, sever limited mouth opening)
- Patients with recurrent cancerous lesions.
- Edentulous patients.
- Previously radiotherapy for head and neck
- Smoking.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Effect of Using Conventional and Digital Oral Positional Radiation Stent on Healthy Tissues, Salivary PH
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.
Read the 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.
Patient's 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 technique.27
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.
- Conditions
- Radiotherapy Side Effect
- Being tested
- conventional oral positioning stent were used during radiation planning and the PTV will be defined and contoured in computed tomography pre irradiation planning, Digital positioning stent
- Keywords
- Radiation, Positioning stent, Removable prosthesis
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional oral positioning stent were used during radiation planning and the PTV will be defined and contoured in computed tomography pre irradiation planningDevice
Dosimetric analysis: the maxilla (area of the teeth), both parotid glands (ipsilateral and contralateral), the mandible, and the PTV were defined and contoured in computed tomography pre irradiation planning. The mean corresponding dose of each structure were acquired using a dose-volume histogram.
All patients will complete the radiotherapy sessions using the positional radiation prosthesis.
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: Collection of saliva sample were done from each patient to measure salivary PH by digital PH meter before beginning of radiotherapy and the measurement will be continued weekly till the end of the treatment.
Digital positioning stentDevice
Digital positioning stent
| Study group | Role | What they receive |
|---|---|---|
| conventional positioning stent | Placebo comparator | The Oral positioning stent were constructed according to the conventional technique Receives: Device: conventional oral positioning stent were used during radiation planning and the PTV will be defined and contoured in computed tomography pre irradiation planning |
| Digital positioning stent | Active comparator | The Oral positioning stent will be constructed digitally Receives: Device: Digital positioning stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosimetric analysis
The teeth away from the target site, both parotid glands and the maxilla, and OARs were defined and contoured in CT pre-irradiation planning using ECLIPSE software to each patient with the stent and without it and the mean corresponding dose of each structure was acquired using a dose volume histogram (DVH).
Measured: 1 week
PH of saliva measurement:
Salivary PH was measured by digital PH meter before beginning of RT and the measurement was continued weekly throughout the treatment period till its end.
Measured: 4 weeks
Mucositis assessment:
The severity of mucositis was assessed weekly from the beginning of RT to the end of the treatment at the RT department. The grading was scored in accordance with the Mucositis grading of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), grading scores from 0-4 which 0 means better (None) and 4 means worse (Necrosis or deep ulceration; may include bleeding not induced by minor trauma or abrasion)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start14 Oct 2019
- Primary completion1 Oct 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy Side EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Hesham Maklad, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353724
- Sponsor's protocol ID
- RP2218
- Acronym
- stent
- Status last verified
- Apr 2024
- First submitted
- 20 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effect of Using Conventional and Digital Oral Positional Radiation Stent on Healthy Tissues, Salivary PH
- ClinicalTrials.gov ID
- NCT06353724
- Acronym / sponsor ID
- stent / RP2218
- Conditions
- Radiotherapy Side Effect
- Keywords
- Radiation, Positioning stent, Removable prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Patient's 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 technique.27
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional positioning stent | Placebo comparator | Device: conventional oral positioning stent were used during radiation planning and the PTV will be defined and contoured in computed tomography pre irradiation planningThe Oral positioning stent were constructed according to the conventional technique |
| Digital positioning stent | Active comparator | Device: Digital positioning stentThe Oral positioning stent will be constructed digitally |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Limit of age was between 20 -40 years old.
- Inter-arch distance ≥ 1.5 cm
- Good oral hygiene.
Key exclusion criteria (5 listed)
- Patients with conditions that limited the construction of the stent (e.g. gross tumor block most of the oral cavity, sever limited mouth opening)
- Patients with recurrent cancerous lesions.
- Edentulous patients.
- Previously radiotherapy for head and neck
- Smoking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional oral positioning stent were used during radiation planning and the PTV will be defined and contoured in computed tomography pre irradiation planningDosimetric analysis: the maxilla (area of the teeth), both parotid glands (ipsilateral and contralateral), the mandible, and the PTV were defined and contoured in computed tomography pre irradiation planning. The mean corresponding dose of each structure were acquired using a dose-volume histogram. All patients will complete the radiotherapy sessions using the positional radiation prosthesis. 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: Collection of saliva sample were done from each patient to measure salivary PH by digital PH meter before beginning of radiotherapy and the measurement will be continued weekly till the end of the treatment. | Device | conventional positioning stent |
| Digital positioning stentDigital positioning stent | Device | Digital positioning stent |
Primary outcome
Dosimetric analysis
Time frame: 1 week
The teeth away from the target site, both parotid glands and the maxilla, and OARs were defined and contoured in CT pre-irradiation planning using ECLIPSE software to each patient with the stent and without it and the mean corresponding dose of each structure was acquired using a dose volume histogram (DVH).
PH of saliva measurement:
Time frame: 4 weeks
Salivary PH was measured by digital PH meter before beginning of RT and the measurement was continued weekly throughout the treatment period till its end.
Mucositis assessment:
Time frame: 4 weeks
The severity of mucositis was assessed weekly from the beginning of RT to the end of the treatment at the RT department. The grading was scored in accordance with the Mucositis grading of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), grading scores from 0-4 which 0 means better (None) and 4 means worse (Necrosis or deep ulceration; may include bleeding not induced by minor trauma or abrasion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional oral positioning stent were used during radiation planning and the PTV will be defined and contoured in computed tomography pre irradiation planning and Digital positioning stent in people with Radiotherapy Side Effect, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosimetric analysis (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.