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Comparison of Three Methods for Treating Deep Dental Cavities in Children

Comparative evaluation of selective caries removal to firm dentin, selective caries removal to soft dentin with 5% sodium hypochlorite lavage, and selective caries removal to soft dentin with Biodentine liner placement: a randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/105366
Enrollment
75
Registered
2026-03-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: K025- Dental caries on pit and fissure surface

Interventions

Intervention1: SRFD with Biodentine liner (control): Group 1 (Control): Selective caries removal to firm dentin (SRFD) followed by Biodentine liner placement. Intervention2: SRSD with 5% sodium hypoc

Sponsors

Self
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 6 15 years of either gender, in good general health. At least one permanent posterior tooth with deep carious lesion extending into of dentin, confirmed radiographically (ICDAS score 5 6). Asymptomatic teeth on clinical evaluation (no spontaneous pain). Parents/guardians providing written informed consent.

Exclusion criteria

Exclusion criteria: Negative response to cold test ( 50 C Endo-Frost spray). Presence of spontaneous pain, pain on palpation/percussion, abscess, fistula, or swelling. Non-carious lesions (attrition, abrasion, erosion, or abfraction). Radiographic signs of periapical pathology (loss of lamina dura, periodontal ligament space widening, root canal obliteration, internal or external resorption). Children with systemic illness or in poor general health. Subjects unwilling to participate or whose parents do not provide consent.

Design outcomes

Primary

MeasureTime frame
Maintenance of pulp vitality (positive response to cold test, absence of spontaneous pain, absence of tenderness on percussion, absence of swelling/abscess/fistula). Absence of radiographic signs of pathology (no periapical radiolucency, no widening of periodontal ligament space, no root resorption, no canal obliteration). Pain assessment using Visual Analog Scale (VAS, 1 10).Timepoint: Immediate post-operative, 3 months, 6 months, 9 months, and 12 months.—

Secondary

MeasureTime frame
Comparative success rate between selective caries removal to soft dentin followed by 5% sodium hypochlorite lavage and selective caries removal to soft dentin followed by Biodentine liner. Comparison of success rates of both SRSD techniques (NaOCl lavage and Biodentine liner) with selective caries removal to firm dentin (SRFD) with Biodentine liner (control group). Survival of restoration and absence of secondary caries during follow-up.Timepoint: 3 months, 6 months, 9 months, and 12 months.—

Countries

India

Contacts

Public ContactDr, Ritu Namdev

Pt B D Sharma Post Graduate Institute of Dental Sciences

ritunamdev@rediffmail.com9466856929

Outcome results

None listed

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