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Direct pulp capping versus partial pulpotomy using RetroMTA in deeply carious primary molars with normal pulp or reversible pulpitis: a superiority randomized controlled trial

Comparison of Success Rate between Direct Pulp Capping and Partial Pulpotomy by Using RetroMTA in Primary Molars with Carious Pulp exposure: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240508001
Enrollment
76
Registered
2024-05-08
Start date
2023-08-18
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Primary molars with carious pulp exposure Direct Pulp Capping Partial pulpotomy Vital pulp therapy

Interventions

When there was a pulp exposure, the cavity was rinsed with normal saline solution and pulp vitality was assessed based on its appearance, including a resilient texture, bright red colour, and bleeding
Experimental Procedure/Surgery,Experimental Procedure/Surgery
Direct pulp capping,Partial pulpotomy

Sponsors

Faculty of Dentistry, Chiang Mai University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 9 Years

Inclusion criteria

Inclusion criteria: 1) Patients aged between 3 and 9 years. 2) Patients and guardians are willing to attend and compliance to follow-up 3) Healthy patients (ASA class I and II) 4) Patients has at least one primary molar tooth with deep carious lesion 5) Tooth should be restorable with stainless steel crown 6) Tooth has no history of soft tissue swelling, fistula tract, and pathologic mobility 7) Exposure size not exceeding 2 mm. 8) Bleeding should be controlled within 4 minutes 9) Radiographically, radiolucency reaching inner one-third of dentin 10) Radiographically, absence of pathological internal or external root resorption and radiolucency at the periapical or furcation areas 11) Radiographically, absence of root canal obliteration or dentin bridge formation

Exclusion criteria

Exclusion criteria: 1) Patients with ASA class II and IV 2) Patients age below 3 years and more than 9 years 3) Patients and guardians are not willing to attend 4) Tooth can not be restorable with stainless steel crown 5) Tooth has history of soft tissue swelling, fistula tract, and pathologic mobility 6) Exposure size exceeding more than 2 mm. 7) Bleeding can not controlled within 4 minutes 8) Radiographically, radiolucency not reaching inner one-third of dentin 9) Radiographically, presence of pathological internal or external root resorption and radiolucency at the periapical or furcation areas 10) Radiographically, presence of root canal obliteration or dentin bridge formation

Design outcomes

Primary

MeasureTime frame
clinical and radiographic outcome of Direct Pulp Capping and Partial Pulpotomy approximately 6-month follow-up intervals up to 24 months. cumulative survival probability

Secondary

MeasureTime frame
clinical and radiographic outcome of Direct Pulp Capping and Partial Pulpotomy approximately 6-month follow-up intervals up to 24 months. success rate

Countries

Thailand

Contacts

Public ContactNattakan Chaipattanawan

Faculty of Dentistry, Chiang Mai University

nattakan.chai@cmu.ac.th0954507238

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026