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Evaluation of success of Complete Pulpotomy procedure using two different Calcium Silicate Biomaterials in patients with irreversible pulpitis.

Comparative Evaluation of the Treatment Outcome of Complete Pulpotomy using two different Calcium Silicate Biomaterials in Mature Permanent Molars with Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial with a 1 Year Follow-Up - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079085
Enrollment
396
Registered
2025-01-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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: Calcium Silicate Glass: An inferior alveolar nerve block with 1.5 mL of 2% lignocaine containing 1:80,000 adrenaline will be used for anesthesia. After confirmation of anesthesia and ru

Sponsors

All India Institute of Medical Sciences, Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Teeth diagnosed with Symptomatic Irreversible Pulpitis. 2. Mature Permanent molars. 3. Healthy patients (age 18-30 years) without systemic diseases or allergic reactions (ASA I and ASA II). 4. No associated pathologic mobility of the tooth. 5. No significant periapical changes, periapical index (PAI) = 2. 6. Active bleeding pulp tissue observed upon access opening. 7. Hemostasis achieved within 10 min after complete pulpotomy.

Exclusion criteria

Exclusion criteria: 1.Teeth with pathologic mobility, associated sinus tract, necrotic pulp tissue (i.e., absence of hemorrhage in pulp chamber), or unrestorable teeth. 2.PAI score more than 2. 3.Teeth with radiolucency in the furcation area, presence of internal or external root resorption, or pulp canal obliteration. 4.Teeth in which hemostasis cannot be achieved within 10 minutes. 5.Individuals not giving written consent. 6.Pregnant and lactating mothers.

Design outcomes

Primary

MeasureTime frame
To determine the clinical success and radiographic outcome of tricalcium silicate and calcium silicate glass biomaterials following complete pulpotomy in teeth with symptomatic irreversible pulpitis.Timepoint: Post-operatively- 24 hours, 3 months, 6 months, and 1 year. Follow-up radiographs will be taken at 3 months, 6 months, and 1 year.

Secondary

MeasureTime frame
To comparatively evaluate the radiopacity of tricalcium silicate and calcium silicate glass biomaterials.Timepoint: Time Points-3 months, 6 months, and 1 year.

Countries

India

Contacts

Public ContactNilovi Swu

All India Institute of Medical Sciences

kumarpr@aiimsjodhpur.edu.in9818402220

Outcome results

None listed

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