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Effectiveness of Acrylic stents in reducing side effects of radiotherapy for oral cancers

Effectiveness of PET-G vacuum formed stents in repositioning the oral tissues, and reducing side effects of radiotherapy for oral and nasopharyngeal cancers: A randomised controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078317
Enrollment
30
Registered
2024-12-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: PET-G formed oral tissues repositioning stent: The designed intraoral repositioning stent made from vacuum-formed PET-G sheets, with a thickness of 3mm, will be used during every sessio

Sponsors

AIIMS Mangalagiri
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with Oral Cavity, Oropharyngeal, Nasopharyngeal and Maxillary Sinus cancers Exposed to the same radiation field and radiation source and dosages between 60 and 70 Gy Mouth opening allowing to take dental impressions The patient should be able to provide a salivary sample Dental condition enabling adequate stent retention

Exclusion criteria

Exclusion criteria: Local extension of carcinomatous tissue which will interfere with appliance fabrication or cause trauma Active intraoral infection Recurrence of carcinomas Previous history of radiation for treatment of cancers Cases with resected salivary glands.

Design outcomes

Primary

MeasureTime frame
Dose sparing effect as measured by dose volume histogram, accuracy of patient positioning progression of muscositisTimepoint: Dose sparing effect as measured by dose volume histogram, accuracy of patient positioning will be evaluated during all radiotherapy sessions. Baseline data will be collecetd at time point zero for mucocitis, salivary flow and mouth opening. Mucocitis will be evaluated weekly at week 1, week 2 , week 3 and week 4. Mouth opening at salivary flow will be evaluated after 3 months.

Secondary

MeasureTime frame
progression of muscositis, reduction in salivary flow (xerostomia) and reduction in mouth openingTimepoint: 1 month and 3 months

Countries

India

Contacts

Public ContactDr. Jitendra Chawla

All India Institute Of Medical Sciences, Mangalagiri

jitendra.dental@aiimsmangalagiri.edu.in07020692463

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026