A study to compare two treatment procedures for painful primary molars with inflammed dental pulp

Treatment Outcomes of Pulpotomy Versus Pulpectomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis: Protocol for a Non-inferiority Randomised Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/062274

Enrollment

Registered

2024-02-05

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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: Removal of only coronal tooth pulp from vital primary molars diagnosed with irreversible pulpitis. Total duration of the pulpotomy intervention will be approximately 30 minut

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy (ASA I and II) co-operative children (Frankl Scale + and ++) between the ages of four and nine years. 2. Participants have symptoms typical of irreversible pulpitis in one of the primary molars. 3. The pulp of the affected primary molar is vital. 4. Radicular pulp health is confirmed by attainment of radicular pulp haemostasis within 8 minutes of coronal pulp amputation. 5. The affected primary molars can be restored with full coverage crowns. 6. Any physiologic root resorption, if present, is less than ? the root length

Exclusion criteria

Exclusion criteria: 1. Clinical examination of affected primary molar reveals signs of pulpal infection (e.g. pathologic tooth mobility, parulis, fistula or soft tissue swelling. 2. Pre-operative periapical radiograph suggests presence of periapical radiolucency. 3. Pre-operative periapical radiograph suggests presence of furcal radiolucency more than ½ the furcation to periapical area. 4. Visual examination of pulp tissue after deroofing reveals signs of necrosis (e.g. avascular or minimally bleeding pulp tissue, yellowish necrotic areas, or purulent exudate). 5. Signs of extensive radicular pulp inflammation. 6. Parents not willing to place full coverage crowns post-treatment. 7. Clinical diagnosis of irreversible pulpitis between two primary molars is not sharply defined.

Design outcomes

Primary

Measure	Time frame
1. Post-treatment clinical success: Determined based on treated tooth meeting all clinical success criteria (Absence of pain or discomfort; Absence of tenderness on percussion or palpation; Absence of parulis or fistula; Absence of soft tissue swelling; and Absence of any pathological mobility). 2. Post-treatment radiographic success: Determined based on treated tooth meeting radiographic success criteria (No signs of pathological internal or external root resorption; No new furcal or periapical lesions; Complete radiographic healing or reduction or no change in the size of any pre-treatment furcal lesions).Timepoint: 6, 12 and 24 months	—

Measure

Time frame

1. Post-treatment clinical success: Determined based on treated tooth meeting all clinical success criteria (Absence of pain or discomfort; Absence of tenderness on percussion or palpation; Absence of parulis or fistula; Absence of soft tissue swelling; and Absence of any pathological mobility). 2. Post-treatment radiographic success: Determined based on treated tooth meeting radiographic success criteria (No signs of pathological internal or external root resorption; No new furcal or periapical lesions; Complete radiographic healing or reduction or no change in the size of any pre-treatment furcal lesions).Timepoint: 6, 12 and 24 months

—

Secondary

Measure	Time frame
Immediate post-treatment pain reliefTimepoint: 24 hours and 7-days	—

Countries

India

Contacts

Public ContactDr Joe Cherian

Christian Dental College, CMC Ludhiana

joemathewcherian@gmail.com9501708436

Outcome results

None listed

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