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The use of a premixed bioceramic material in the pulp cavity of decayed primary teeth in children

Evaluation of premixed bioceramic material (NeoPUTTY®) as a pulpotomy material for primary molars: A randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN98720643
Enrollment
70
Registered
2022-09-14
Start date
2021-05-01
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Dental caries requiring pulpotomy treatment Oral Health

Interventions

Children aged between 4 and 10 years old attending the pediatric dental clinics at Dental University Hospital, King Khaled Medical City, King Saud University will be screened for teeth with deep carie

Sponsors

King Saud University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children aged between 4 and 10 years old 2. Healthy (ASA Physical Status Classification System I and II) 3. Cooperative (positive or definitely positive behavior according to Frankl behavior scale) 4. Deep dentin caries approximating or reaching the pulp without any signs or symptoms of pulpal degeneration in one or more primary molar 5. Primary molars clinical inclusion criteria: no history of spontaneous or persistent pain; restorable primary molars with deep carious lesions approximating or reaching the pulp; no pathological mobility, no tenderness to percussion, no swelling or sinus tract; hemostasis achieved after coronal pulp amputation within 5 minutes 6. Primary molars radiographic inclusion criteria: deep dentin caries approximating or reaching the pulp; no more than two-thirds of physiologic root resorption; no widening of the periodontal ligament space; no pathologic internal or external root resorption; no apical or furcal radiolucency

Exclusion criteria

Exclusion criteria: 1. Children with special needs 2. Primary molars with uncontrolled bleeding after coronal pulp amputation

Design outcomes

Primary

MeasureTime frame
Clinical and radiographic success rates of both pulpotomy materials measured using an assessment of signs and symptoms by the examiners at 6 and 12 months follow-up

Secondary

MeasureTime frame
Failure type of each group measured by the examiners at 6 and 12 months follow-up

Countries

Saudi Arabia

Outcome results

None listed

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