Comparison Between the Effect of Using Conventional and Digital Oral Positional Radiation Stent

NCT06353724 | Completed

• 1 other identifier: RP2218
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiotherapy Side Effect

Keywords

Radiation; Positioning stent; Removable prosthesis

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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)

  4 weeks

Study Arms (2)

conventional positioning stent

PLACEBO COMPARATOR

The Oral positioning stent were constructed according to the conventional technique

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

Device: Digital positioning stent

Interventions

conventional oral positioning stent were used during radiation planning and the PTV will be defined and contoured in computed tomography pre irradiation planning DEVICE

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.

conventional positioning stent

Digital positioning stent DEVICE

Digital positioning stent

Digital positioning stent

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Limit of age was between 20 -40 years old.
• Inter-arch distance ≥ 1.5 cm
• Good oral hygiene.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry

Tanta, Gharbia Governorate, 31527, Egypt

Location

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant at faculty of dentistry

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 9, 2024
• Study Start: October 14, 2019
• Primary Completion: October 1, 2020
• Study Completion: January 1, 2021
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)