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Evaluating bioactive composite resin in class 5 carious lesions

Clinical evaluation of bioactive composite resin in class v carious lesions: a split mouth study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/051088
Enrollment
20
Registered
2023-03-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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: Predicta® Bioactive Bulk-Fill, Parkell: bioactive composite Control Intervention1: 3M� Filtek� Bulk Fill Posterior Restorative: bulk fill posterior restorative material

Sponsors

Dr Apeksha Rao
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Teeth selection: Class v carious lesions with distinct cavitation exposing visible dentin Indicated for restoration without symptoms. Posterior teeth only. Surfaces involved: buccal only. Dimensions of lesion Measured using a 12 UNC color-coded probe Mesiodistally- 2-4 mm Occlusogingivally â?? 2-4mm Depth â?? 1-2mm Presence of at least 2 cavitated class v lesions following criteria. Patient selection: Age group of 18â??60 years. Ability to give informed consent. Conditions indicative of a high caries risk patient. In accordance with Caries Risk Assessment (Age >6) by ADA: Cavitated or Non-Cavitated (incipient) Carious Lesions or Restorations (visually or radiographically evident): 3 or more carious lesions or restorations in last 36 months

Exclusion criteria

Exclusion criteria: Teeth selection: • Teeth with non carious cervical lesions • Teeth with discoloration, developmental defects or pathological mobility. Patient criteria: • Patients with parafunctional habits

Design outcomes

Primary

MeasureTime frame
FDI criteria for clinical successTimepoint: baseline, 6 months, 12 months

Secondary

MeasureTime frame
over all patient caries reductionTimepoint: baseline, 6 months, 12 months

Countries

India

Contacts

Public ContactDr Anitha R Kumari

Vokkaligara Sangha Dental College and Hospital

anithamanasi18@gmail.com9845919324

Outcome results

None listed

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