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Clinical Trials/ISRCTN98720643
ISRCTN98720643
Completed
N/A

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

King Saud University0 sites70 target enrollmentSeptember 14, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dental caries requiring pulpotomy treatment
Sponsor
King Saud University
Enrollment
70
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37381123/ (added 11/07/2023)

Registry
who.int
Start Date
September 14, 2022
End Date
September 20, 2022
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility 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

  • 1\. Children with special needs
  • 2\. Primary molars with uncontrolled bleeding after coronal pulp amputation

Outcomes

Primary Outcomes

Not specified

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