Reversal of early decay of teeth using newly introduced material in 6 to 8 year old children

Remineralization potential of self-assembling peptide P11-4 on early enamel caries in 6 to 8 year old children. A randomized control trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/026016

Enrollment

Registered

2020-06-22

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

Health Condition 1: K026- Dental caries on smooth surface

Interventions

Intervention1: Bifluorid 10Â®: Application of the material will be done at the start of the procedure, following which remineralization will be accessed in 3rd and 6th month post application Control I

Eligibility

Inclusion criteria

Inclusion criteria: Erupted permanent first molar with initial enamel lesions (ICDAS-II scoring 1-3, DIAGNOdent readings 5-20). Written informed consent will be obtained from the participating children and their parents prior to any study-related procedures

Exclusion criteria

Exclusion criteria: Children with medication affecting salivary flow, evidence of tooth erosion, fluoride varnish application <3 months prior to study treatment, any metabolic disorders affecting bone turnover, or concurrent participation in another clinical trial.

Design outcomes

Primary

Measure	Time frame
Change in the progression of carious lesions using ICDAS-II criteria and DIAGNOdentTimepoint: 3 and 6 months	—

Secondary

Measure	Time frame
Mineral gain in early enamel lesionTimepoint: 3 and 6 months	—

Countries

India

Contacts

Public ContactDr N Sridhar

Manipal College of Dental Sciences Manipal

drsri.pedo@gmail.com9886932642

Outcome results

None listed

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