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Comparison of tooth colored and metal crown for primary teeth.

Clinical and radiographic evaluation of preformed Bioflx ™ and stainless steel crowns on vital primary molars : A randomized controlled trial. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067672
Enrollment
30
Registered
2024-05-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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: Bioflx: The selected tooth will be restored using GIC. This will be followed by tooth preparation and cementation of the bioflx crown. the approximate time required for the procedure wi

Sponsors

Dr DY Patil Deemed to be University School of Dentistry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) 3-9 year old under the ASA class 1 b) Primary molars with multisurface caries or wide proximal caries without clinical and radiographic signs of pulp pathology c) Primary molars without pathological root resorption d) Frankl’s rating score of positive or definitely positive e) Presence of antagonist tooth

Exclusion criteria

Exclusion criteria: a) Children whose parents did not give consent for participation in the study b) Children with systemic illness OR on medicines that may alter the gingival health c) Physiological root resorption of more than one-third of root length d) Habit of bruxism

Design outcomes

Primary

MeasureTime frame
The proximal contact, marginal extension, occlusion, indentations on crown, retention of crown, staining of crown, gingival index, plaque index, and parental acceptability for both SSC and Bioflx crowns will be evaluated as primary outcomesTimepoint: The time points at which the evaluation will be done are 1 week, 1 month, 3 months and 6 months

Secondary

MeasureTime frame
The tooth wear in the opposing arch will be evaluated as secondary outcome measure.Timepoint: The evaluation will be done at 1 week, 1 month, 3 months & 6 months of follow up

Countries

India

Contacts

Public ContactDr Parnaja Valke

Dr. D.Y. Patil Deemed to be University, School of Dentistry, Navi Mumbai.

valkeps@gmail.com9881274378

Outcome results

None listed

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