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Comparative Evaluation of Biodentine and Mineral Trioxide Aggregate for Pulpotomies in Mature Permanent Teeth with Irreversible Pulpitis: A Randomised Clinical Trial at the University of Maiduguri Teaching Hospital

Comparative Evaluation of Biodentine and Mineral Trioxide Aggregate for Pulpotomies in Mature Permanent Teeth with Irreversible Pulpitis: A Randomised Clinical Trial at the University of Maiduguri Teaching Hospital

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202602730574713
Enrollment
76
Registered
2026-02-26
Start date
2026-02-16
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

Oral Health

Interventions

Biodentine
Mineral Trioxide Aggregate

Sponsors

Dr. Samaila Stanley
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years and above with no known systemic medical conditions, who provide informed written consent to participate in the study. 2. Moderate-to-severe pain, symptomatic irreversible pulpitis, in a mature mandibular molar diagnosed with irreversible pulpitis secondary to caries. 3. SIP symptoms characterised by spontaneous, referred, or nocturnal pain, along with a pronounced, lingering response (over 30 seconds) to cold testing,10 using Endo-Frost (Coltene Whaledent, Altstatten, Switzerland). Participants must score at least 4 on a Visual Analogue Scale (VAS) for pain assessment. 4. Radiographic examination must show a periapical index (PAI) of less than or equal to 2. 5. Teeth with visible bleeding pulp upon accessing the pulp chamber. 6. If haemostasis is achieved within 10 minutes after coronal pulp amputation.

Exclusion criteria

Exclusion criteria: 1. Patients who do not give informed consent to participate in the study. 2. Patients below 18 years or geriatric patients (above the age of 65 years). 3. Patients with systemic conditions that could affect healing (e.g., diabetes, immunocompromised states). 4. Patients currently taking medications that could influence pain perception or healing (e.g., long-term steroid use). 5. Periapical index (PAI) greater than 2. 6. Teeth with mobility, associated sinus tracts, necrotic pulp (indicated by negative response to pulp testing, or lack of bleeding in the pulp chamber), or teeth that cannot be restored. 7. Presence of significant radiolucency in the furcation area and any evidence of internal or external root resorption, calcifications, or pulp canal obstructions. 8. If haemostasis of the pulp stump cannot be achieved within 10 minutes after coronal pulp amputation.

Design outcomes

Primary

MeasureTime frame
Clinical and radiographic success of pulpotomy

Secondary

MeasureTime frame
Postoperative pain intensity;Analgesic consumption

Countries

Nigeria

Contacts

Public ContactSamaila Stanley

Senior Registrar

stansaqm@gmail.com+2348135722979

Outcome results

None listed

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