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Evaluation of restoration quality in 3-8 years old children between bioactive restorative material and bulk filled composite

Comparison of clinical performance between Bioactive restorative material and bulk filled composite in class II cavity for primary molars using Federation Dentaire Internationale (FDI) criteria: a clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043610
Enrollment
64
Registered
2022-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

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

Conditions

Health Condition 1: K02- Dental caries

Interventions

Intervention1: ACTIVA Kids BioACTIVE Restorative material: ACTIVA Kids BioACTIVE combine the esthetics, strength and resilience of composites with bioactive properties that are superior to glass iono

Sponsors

Charmi Shah
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy children with ASA I score, with a Frankl behavior rating of 3 or 4. 2.Children who have class II carious lesion involving enamel and dentin in 1st and 2nd primary molar. 3.Teeth with International caries detection and assessment system score of 4 and 5. 4.Radiographically there should be presence of radiolucency confined to the outer half of the dentine, normal Lamina Dura and periodontal space, and permanent teeth germ below the primary teeth in normal position with a predicted survival of the primary tooth of at least 2 years until normal exfoliation

Exclusion criteria

Exclusion criteria: 1.The teeth with spontaneous pain, swelling, fistula, abscess or tenderness on percussion will be excluded. 2.Children suffering from any illness requiring special medical care. 3.Parents not giving consent for the treatment.

Design outcomes

Primary

MeasureTime frame
FDI CRITERIA INCLUDE: 1) Esthetic Surface luster Surface Staining Color match Anatomic Form 2)Function Fracture and retention Marginal adaptation Wear of the restoration Presence of contact point Food Impaction 3)Biological Secondary caries State of mucosa adjacent to restoration Post-Operative sensitivity Timepoint: 24 hours, 6 months and 9 months

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Seema Bargale

Sumandeep Vidyapeeth an Institute Deemed to be University

drseemabargale@gmail.com9586115657

Outcome results

None listed

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