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Comparison of Indirect Pulp Therapy and iRoot BP Plus Pulpotomy in Primary Teeth With Deep Extremely Dentinal Caries: A Randomised Trial

Comparison of Indirect Pulp Therapy and Pulpotomy in Primary Teeth With Deep Dentinal Caries

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032462
Enrollment
Unknown
Registered
2020-04-29
Start date
2017-01-01
Completion date
Unknown
Last updated
2020-08-24

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

Conditions

caries

Interventions

calcium hydroxide indirect pulp therapy (IPT) group:calcium hydroxide IPT
iRoot BP plus pulpotomy group:iRoot BP plus pulpotomy

Sponsors

Peking University School and Hospital of Stamotology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 8 Years

Inclusion criteria

Inclusion criteria: general healthy children aged 3-8-years, need to be treated under general anesthesia due to deep caries of primary molars, at least one primary molars was diagnosed as deep caries (normal pulp) or reversible pulpitis; referred to the European Society of Endodontology (ESE) approved definition of deep caries: caries reaching the inner quarter of dentin, but with a zone of hard or firm dentine between the caries and the pulp, which is radiographically detectable when located on an interproximal or occlusal surface. There is a risk of pulp exposure during operative treatment; there are no manifestations of irreversible pulpitis, such as spontaneous pain and persistent pain history; absence of abnormal mobility or fistula and gingival swelling in clinical examination; radiologically, the depth of caries on the pre-operative film exceeds 3 / 4 of the thickness of dentin, absence of widening of periodontal membrane space, absence of radiolucencies at the interradicular or periapical regions, absence of pathological internal or external root resorption, absence of physiological root absorption. The final case selection of IPT group was based on the absence of pulp exposure before the selective caries removal to soft dentine, which followed the definitions and standards of ESE statement

Exclusion criteria

Exclusion criteria: with general illness

Design outcomes

Primary

MeasureTime frame
success rate of 12 months and 24 months;

Secondary

MeasureTime frame
survival analysis;

Contacts

Public ContactChen Xiaoxian

Peking University School and Hospital of Stamotology

chenxiaox2007@126.com+86 13681471030

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 25, 2026