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In children, when there is pain due to pulp involvement, the success rate between pulpotomy treatment and pulpectomy treatment will be compared.

Treatment effectiveness of pulpotomy as compared to pulpectomy for management of symptomatic irreversible pulpitis in primary teeth: A randomized controlled trial - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093102
Enrollment
100
Registered
2025-08-14
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: Pulpotomy: The pulpotomy will adhere to standard clinical procedural guidelines. The bio-dentine material will be used as pulp medicament for pulpotomy. All the treatment teeth will be

Sponsors

ESIC dental College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy children with carious teeth between the ages of 4 to 10 years will be invited to participate in the study inclusion criteria: (i) symptoms typical of irreversible pulpitis (ii) the primary molar is restorable with stainless steel crown; and (iii) iv) any physiologic root resorption, if present, is less than 1/3 the normal root length.

Exclusion criteria

Exclusion criteria: exclusion criteria: (i) clinical sign/symptoms of pathologic tooth mobility, parulis/fistula, or soft tissue swelling; (ii) preoperative periapical radiograph suggests presence of furcal radiolucency more than the furcation to periapical area; (iii) pre-operative periapical radiograph suggests presence of periapical radiolucency/pathological root resorption (iv) Intra-operatively, visual examination of pulp tissue reveals signs of necrosis i.e., avascular/minimally bleeding pulp tissue or yellowish necrotic areas/purulent exudate.

Design outcomes

Primary

MeasureTime frame
Clinical and radiographic outcomes will be assessed independently by two trained, calibrated examiners and shall be blinded to the treatment or follow up time interval. Clinical success of the treated tooth will be determined based on no clinical symptoms of pain/tenderness on percussion/ parulis/fistula/soft tissue swelling/pathological mobility etc. Radiographic success will be determined by no signs of pathological changes.Timepoint: 3 months 6 months 12 months

Secondary

MeasureTime frame
Survival analysis will be calculated for the two procedures for the follow up period.Timepoint: one year;Pre-operative and post-operative pain intensity will be assessed using the Visual Analogue Scale.Timepoint: at 24 h and 7 days

Countries

India

Contacts

Public ContactHitesh Chander

ESIC dental college and hospital Kalaburagi

dr.hiteshmittal@gmail.com8607707755

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026