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Comparing performance of two dental filling materials for decay in between milk molar teeth

Bioactive Alkasite Based Material Compared With Resin Modified Glass Ionomer Cement For Proximal Restorations in primary molars -A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087089
Enrollment
20
Registered
2025-05-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: Restoration Of proximal caries in primary molars.: Restorative materials to be used: Test group: Bioactive alkasite based material-Cention Forte(Ivoclar) Intervention2: Bioactive alka

Sponsors

Dr Jeel Gala
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Healthy children aged 4 to 8 years 2 Presence of at least two contralateral primary molars with proximal caries involving either the mesial or distal marginal ridge which is not extending beyond the line angles and is requiring restoration 3 Selected teeth should be free of symptoms suggestive of irreversible pulpitis like spontaneous or nocturnal pain with remaining dentin thickness of at least 1mm radiographically 4 Children showing Frankl s behavior rating 3 & 4 5 Children whose parents consent for their participation in the study by signing the written informed consent 6 Patients likely to be available for scheduled recall visits

Exclusion criteria

Exclusion criteria: 1 Children with long term systemic illness and those with special health care needs 2 Teeth with proximal carious lesions extending beyond the proximal line angles of the tooth 3 Teeth with remaining dentin thickness less than 1 mm with history of spontaneous nocturnal pain with evidence of pulp exposure or with abscess or fistula and mobility 4 Previously restored teeth with either fracture of restoration or presence of secondary caries 5 Children showing Frankl s behavior rating 1 & 2 6 Teeth with hypoplastic defects 7 Children with positive history of bruxism or allergy to any content of the material to be used in the study

Design outcomes

Primary

MeasureTime frame
To rate by Modified USPHS CRITERIA A).Marginal discoloration. B).Marginal integrity. c)Surface texture. d) Wear. e) secondary caries. Timepoint: 2 years

Secondary

MeasureTime frame
nilTimepoint: nil

Countries

India

Contacts

Public ContactDr Rashmi Nayak

Manipal College of Dental Sciences, Manipal

rashmi.nayak@manipal.edu09845364987

Outcome results

None listed

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