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Assessing a Special Tooth Repair Material (Calcium Silicate-Doped Dentin) for Treating Deep Cavities While Keeping the Tooth Alive

Comparative evaluation of calcium silicate-doped treated dentin matrix and mineral trioxide aggregate as miniature pulpotomy biomaterials in deep carious lesions: a parallel, double-blind, randomized clinical trial - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084767
Enrollment
56
Registered
2025-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: Miniature Pulpotomy using calcium silicate- doped Human treated dentin matrix (hTDM) as a medicament: hTDM will be placed as a medicament over vital pulp tissue after caries excavation.

Sponsors

Muhammad Hamdan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Clinical diagnosis of reversible pulpitis. Positive response to pulp sensibility tests. Normal periapical tissues (PAI index less or equal to 2). Presence of carious lesion involving three fourth or entire thickness of dentin. (Deep or extremely deep carious lesions)

Exclusion criteria

Exclusion criteria: History of spontaneous unprovoked pain Pain on percussion, sinus tract, swelling, excessive mobility. Periodontal pockets greater than 4 mm. Presence of a crack. Profuse hemorrhage from exposure site (greater than 5 minutes) Presence of serous or purulant exudates from exposure site. Teeth with traumatic occlsuion, non carious lesions, developmental defects. Radiographic evidence of internal or external resorption, calcifications, condensing osteitis or furcal and periapical radiolucency.

Design outcomes

Primary

MeasureTime frame
Pulp Vitality assessed by Cold TestingTimepoint: 7 days, 3 months, 6 months

Secondary

MeasureTime frame
Post operative Pain using NRS-11 scaleTimepoint: 24, 48, 72 hours and 7 days.;Presence or absence of Swelling, sinus tractTimepoint: 7 days, 3 months, 6 months;Presence or absence of Tenderness on percussionTimepoint: 7 days, 3months, 6 months;Pocket depth (mm)Timepoint: 7 days, 3 months, 6 months;Mobility (Grading)Timepoint: 7 days, 3 months, 6 months;Radiographic outcome: Periapical Index (PAI) scoreTimepoint: 7 days, 3 months, 6 months;Presence or absence of resorption (Internal/External)Timepoint: 7 days, 3 months, 6 months

Countries

India

Contacts

Public ContactProf Dr Ganesh Jadhav

All India Institute of Medical Sciences, AIIMS Nagpur

drganesh2009aiims@gmail.com9823649979

Outcome results

None listed

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