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To evaluate increase in the salivary flow rate of xerostomic patients post-radiotherapy by using salivary stimulants

Efficacy of biotene oral balance system and xerostom salivary system on salivary properties, salivary biomarkers (beta- defensin, mucin-7) and caries susceptibility in patients with irradiation induced xerostomia: a single blinded randomized controlled trial - nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/077083
Enrollment
66
Registered
2024-11-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: K029- Dental caries, unspecified Health Condition 2: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Biotene oral balance gel and toothpaste: It has lactoperoxidase, lysozyme, glucose oxidase and xylitol which are responsible for its anti bacterial activity and also makes it a salivar

Sponsors

DrAnam Alam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.With previous radiotherapy treatment where the field of irradiation encompasses the major and minor salivary glands. 2.With a subjective complaint of dry mouth. 3.With at least 10 remaining natural teeth and taking nutrition orally. 4.Participants should have finished radiotherapy 1 week prior to the study with a radiation dose more than 60Gy, present with skin integrity, have no history of neck dissection level I or any tumor lesion in the salivary glands. 5.Participants should report complaints compatible with xerostomia and hyposalivation, which will be later confirmed by sialometry.

Exclusion criteria

Exclusion criteria: 1.Patients with performing stimulated salivary flow rate (SSF) above 1mL/min. 2.Patients having severe dysphagia, or under hyposalivation treatment or salivary stimulants. 3.Patients whose radiation field did not include jaws, edentulous patients. 4.Those receiving a total radiotherapy dose of 50Gy or less.

Design outcomes

Primary

MeasureTime frame
Increase in the salivary flow, pH & buffering capacity & decrease in the caries susceptibilityTimepoint: Baseline 1 month 3 months 6 months

Secondary

MeasureTime frame
noneTimepoint: none

Countries

India

Contacts

Public ContactDr Sonali Taneja

ITS-CDSR, Muradnagar

sonalitaneja@its.edu.in9891688100

Outcome results

None listed

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