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Primary Teeth Pulp Capping Material

“Evaluation of Silver DiamineFlouride & Biodentine as an Indirect Pulp capping agent in Primary teeth-A Randomised Clinical Trial ? - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057966
Enrollment
68
Registered
2023-09-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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: Silver Diamine Fluoride: Kids-e Dental E 38% SDF, Which contains SDF approximately 25% of silver,8% ammonia, 5% fluoride and 62% water Control Intervention1: Biodentine (Control): Bio

Sponsors

Dr. Daya Srinivasan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged 4–7 years with previously untreated lower second primary molars in cooperative children with good general health. 2. Children having had deep dentin caries involving occlusal and or occlusoproximal surfaces. 3. Children who were radiographically detected with caries penetration involving approximately 3/4 of the dentin thickness. 4. Children who were considered to have a potential to result in pulp exposure when the entire caries was cleared according to the complete excavation procedure in which the end point of carious tissue removal is the hard dentin. 5. Children whose teeth showed a moderate response to chemical and thermal stimuli.

Exclusion criteria

Exclusion criteria: 1.Teeth showing signs of irreversible pulpitis (such as spontaneous pain, prolonged pain response) 2.Teeth showing pathological mobility, 3.Teeth showing infectious symptoms such as fistula or abscess, and discoloration 4.Presence of radiolucency in the furcation or periapical regions, and internal or external root resorption. 5.Children with systemic problems, congenital abnormalities and special children.

Design outcomes

Primary

MeasureTime frame
Clinical criteria: Tooth evaluated for presence / absence of pain, swelling, tender on percussion, pathological mobility & gingival sinus tract opening or purulent discharge Radiographic criteria: Evaluated for radiographic radiolucency , furcal involvement, peri apical radiolucency and internal or external resorption. The increase in dentin thickness will be measured using care stream software attached to Radiovisuography keeping cement-enamel junction as a reference .Timepoint: 3, 6,9,12,18, 24 months

Secondary

MeasureTime frame
Histological criteria:Pulpal inflammation, prescence of tertiary dentin, Odontoblastic integrity will be evaluated. Timepoint: After 6 months follow up

Countries

India

Contacts

Public ContactDr Daya Srinivasan

Department of Pedodontics and Preventive Dentistry, Chettinad Dental College and Research Institute

dayaswathi@gmail.com9884476385

Outcome results

None listed

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