To compare minimally invasive approaches of Self assembling peptide (SAP) with Resin infiltration (RI) for management for initial smooth surface carious lesions

COMPARATIVE EVALUATION OF RESIN INFILTRATION AND SELF ASSEMBLING PEPTIDES AS MINIMALLY INVASIVE INTERVENTIONS FOR INITIAL SMOOTH SURFACE ENAMEL CARIOUS LESIONS IN PERMANENT TEETH RANDOMIZED CONTROLLED STUDY - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085123

Enrollment

134

Registered

2025-04-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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: Self-assembling Peptides: application of self assembling peptide biomimetic agent (Curodont repair) on white spot lesions Control Intervention1: DMG icon resin infiltrant: Application o

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with high caries likelihood as classified under ICCMS protocol. Patients presenting with initial stage carious lesions (as per ICDAS merged categories) on buccal/facial permanent tooth surfaces in either maxillary or mandibular arch. Patients whose parents give consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1.Patient presenting with moderate/extensive stage carious lesions (as per ICDAS merged categories). 2.Patient with any metabolic disorder, medically compromised conditions. 3.Patient with tooth staining, tooth developmental defects/anamolies. 4. Patient with previous history of non-invasive/microinvasive caries management interventions. 5. Patients who denied assent or whose parents did not agree to participate in the study. 6. Patients with history of xerostomia or any condition that reduces salivary flow.

Design outcomes

Primary

Measure	Time frame
-Change in carious lesions status (progression/regression) -Change in carious lesion size area Timepoint: Following outcomes shall be observed by two independent observers blinded to the intervention at time periods T0 (baseline), T1 (immediate post-intervention), T2 (one month post intervention) and atT3 (six months post intervention).	—

Secondary

Measure	Time frame
-Change in carious lesion estheticsTimepoint: Following outcomes shall be observed by two independent observers blinded to the intervention at time periods T0 (baseline), T1 (immediate post-intervention), T2 (one month post intervention) and atT3 (six months post intervention	—

Countries

India

Contacts

Public ContactDrRicha Khanna

Faculty of dental sciences KGMU lucknow

Richa.bahal@gmail.com9936038511

Outcome results

None listed

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