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A Study on the Success Rate of Pulpotomy and Root Canal Therapy for Irreversible Pulpitis of Primary Molars

A Study on the Success Rate of Two Endodontic Treatment Techniques for Irreversible Pulpitis of Primary Molars

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102332
Enrollment
Unknown
Registered
2025-05-13
Start date
2025-06-02
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

Irreversible pulpitis of primary molars

Interventions

The active comparator arm:Pulpectomy
Experimental intervention arm:Pulpotomy

Sponsors

Shanghai Stomatological Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 9 Years

Inclusion criteria

Inclusion criteria: 1.Healthy (ASA I and II) co-operative children (Frankl Scale + and + +) between the ages of 4 to 9 years will be invited to participate in the study; 2.Symptoms typical of irreversible pulpitis i.e., spontaneous unprovoked pain lasting few seconds to several hours in the days before the dental visit or pain that is exacerbated by hot and/or cold stimuli with the pain lingering even after removal of stimuli; 3.Post-deroofng the pulp chamber, vitality of the primary molar tooth is confrmed by visual inspection of pulpal haemorrhage (uniformly reddish pink vascular tissue indicates healthy pulp); 4.Post-coronal pulp amputation, radicular pulp health is confrmed by attainment of radicular pulp haemostasis within 10-min of compression with a 3% sodium hypochlorite (NaOCl)-dampened cotton pellet; 5.The primary molar is restorable with stainless steel crown; 6.Any physiologic root resorption, if present, is less than 1/3 the normal root length.

Exclusion criteria

Exclusion criteria: 1.Clinical examination reveals signs of pulpal infection i.e., pathologic tooth mobility, parulis/fstula, or soft tissue swelling; 2.Preoperative periapical radiograph suggests presence of furcal radiolucency; 3.Pre-operative periapical radiograph suggests presence of periapical radiolucency; 4.Pre-operative periapical radiograph suggests presence of pathological root resorption; 5.Post-deroofng the pulp chamber, visual examination of pulp tissue reveals signs of necrosis i.e., avascular/minimally bleeding pulp tissue or yellowish necrotic areas/purulent exudate; 6.Post-coronal pulp amputation, there are signs of extensive radicular pulp infammation i.e., bleeding continues even after 10-min compression with NaOCl-soaked cotton pellet; 7.Parents not willing to place full coverage crowns post-treatment; 8.If both primary molars in the quadrant are painful and clinical diagnosis of irreversible pulpitis between the teeth is not sharply defned.

Design outcomes

Primary

MeasureTime frame
Clinical outcomes and Radiographic outcomes;

Secondary

MeasureTime frame
Immediate post-treatment pain relief:;

Countries

China

Contacts

Public ContactYijie Zhang

Shanghai Stomatological Hospital, Fudan University

2521251649@qq.com+86 15510161129

Outcome results

None listed

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