To Check if chewing piper betel leaf along with arecanut from copper based fungicide treated and untreated arecanut palms can lessen the salivay and serum copper levels.

The impact of Piper betel leaf chewing on salivary and serum copper levels in individuals following the chewing of areca nut from copper-based fungicide-treated arecanut palms and untreated arecanut palms-A Randomised Controlled Trial . - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/071957

Enrollment

140

Registered

2024-08-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Health Condition 1: Z00-Z99- Factors influencing health status and contact with health services

Interventions

Intervention1: To estimate the copper levels in the saliva and serum of habitual chewers of arecanut products subjected to chewing arecanut from copper-based fungicide-treated palms. To estimate the c

Eligibility

Inclusion criteria

Inclusion criteria: Individuals habitually chewing areca nut and arecanut products and are willing to participate in the study.

Exclusion criteria

Exclusion criteria: Individuals with history of any other systemic illness.Individuals with the history of medication. Individuals with any salivary gland pathology .Individuals using copper vessels for diet and water intakeIndividuals working with fertilizers.

Design outcomes

Primary

Measure	Time frame
Chewing raw areca nut from copper based fungicide untreated palms along with piper betel leaf decrease salivary copper levels due to the protective and chelating property of betel leaf flavonoids. Timepoint: 2 weeks	—

Secondary

Measure	Time frame
High copper content in areca nuts from copper-based fungicide-treated plantations, compared to untreated ones, potentially leads to elevated salivary copper levels upon chewing and contributes to the development of oral submucous fibrosis (OSF) and oral squamous cell carcinoma. Commercially available areca nut products, which commonly lack betel leaf, can lead to increased risk of OSMF and oral squamous cell carcinoma due to their inclusion of tobacco.It is hypothesized that chewing raw areca nut from copper based fungicide untreated palms along with piper betel leaf may decrease salivary copper levels due to the protective and chelating property of betel leaf flavonoids.this can decrease the incidence of oral submucous fibrosis and oral squamous cell carcinoma Timepoint: 6 months of intervention and stoppage of usage of commercial arecanut and copper fungicide treated arecanuts	—

Measure

Time frame

High copper content in areca nuts from copper-based fungicide-treated plantations, compared to untreated ones, potentially leads to elevated salivary copper levels upon chewing and contributes to the development of oral submucous fibrosis (OSF) and oral squamous cell carcinoma. Commercially available areca nut products, which commonly lack betel leaf, can lead to increased risk of OSMF and oral squamous cell carcinoma due to their inclusion of tobacco.It is hypothesized that chewing raw areca nut from copper based fungicide untreated palms along with piper betel leaf may decrease salivary copper levels due to the protective and chelating property of betel leaf flavonoids.this can decrease the incidence of oral submucous fibrosis and oral squamous cell carcinoma Timepoint: 6 months of intervention and stoppage of usage of commercial arecanut and copper fungicide treated arecanuts

—

Countries

India

Contacts

Public ContactSoma Susan Varghese

Mar Baselios Dental College

pramodmathews@rediffmail.com9995566970

Outcome results

None listed

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