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A clinical research to evaluate the effect of sugar free chewing gum containing CPP-ACP (a milk protein with calcium and phosphate) in prevention of white spots (initial stage of dental caries) in patients wearing braces (clip)

Efficacy of sugar free chewing gum containing casein phosphopeptide amorphous calcium phosphate (CPP-ACP) on demineralization around fixed orthodontic brackets - An in vivo study

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011495
Enrollment
36
Registered
2018-01-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Sugar free chewing gum containing CPP-ACP : Two pellets thrice daily for one month Intervention2: Sugar free chewing gum without CPP-ACP : Two pellets thrice daily for one month Con

Sponsors

Dr Shailaja R
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The criteria for including participants were no active caries lesions, normal salivary flow rate (approximately 1.0 mL/min), and buffer capacity (6.7-7.7). Sound Premolars

Exclusion criteria

Exclusion criteria: active carious lesions, periodontal or any other oral pathology Subjects under antibiotics or any medications that could alter the salivary flow, pH & buffering capacity Dental anomaly- eg. enamel hypoplasia , fluorosis. Premolars- Carious/ Restored / Non vital / Fractured. Patient with known milk protein allergy

Design outcomes

Primary

MeasureTime frame
Vickers Hardness measurement of demineralized enamel around orthodontic bracketsTimepoint: one month

Secondary

MeasureTime frame
Mean VAS pain score due to chewing gumTimepoint: one week;to identify the number of appliance breakagesTimepoint: one month.

Countries

India

Contacts

Public ContactDr Shailaja R

TN Government Dental College

vimalaortho@gmail.com9884417095

Outcome results

None listed

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