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Evaluation of the role of new remineralizing material in prevention of tooth decay in head and neck cancer patients after radiation therapy

The role of novel self assembling peptide matrix (SAPM) in prevention of post radiation caries in head and neck cancer patients: Randomized clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031001
Enrollment
75
Registered
2021-02-04
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: K027- Dental root caries

Interventions

Intervention1: Self Assembling peptide matrix gel: Self-assembling peptide matrix (SAPM) gel will be applied to the tooth surfaces before and after the completion of radiotherapy. The SAPM application

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) Patients of either gender between of age group 18-60 years b) Diagnosis of oral cavity and oropharyngeal squamous cell carcinoma(stage I- IV B) c) Planned radiation dose of � 50 Gy d) Availability of at least eight teeth after oral health clearance e) Patients with adequate motor function to perform routine oral hygiene practices

Exclusion criteria

Exclusion criteria: a) Patients with advanced periodontal disease, diabetes and severely debilitated patients with advanced tumors b) Patients with need of surgical intervention and reconstruction therapy for management of oral cavity and oropharyngeal carcinoma c) Patients not willing to participate in the study

Design outcomes

Primary

MeasureTime frame
development of post radiation cariesTimepoint: at 6 and 12 months post radiation therapy

Secondary

MeasureTime frame
reduced salivary flow rateTimepoint: 3,6 and 12 months

Countries

India

Contacts

Public ContactVijay Kumar

All India Institute of Medical Sciences, New Delhi

kumarvijay29@gmail.com9540055001

Outcome results

None listed

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