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The one-year study compares 3 different materials Mineral Trioxide Aggregate, Human Amniotic Membrane and Bio-C Repair for restoration of pulpotomy treatment in cases of tooth pain in posterior teeth

One Year Comparative Evaluation of Treatment Outcome of Human Amniotic Membrane, Bio-C Repair and Mineral Trioxide Aggregate as pulpotomy agents in mature permanent molars with symptomatic irreversible pulpitis: Double Blinded Randomized Clinical Study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085319
Enrollment
87
Registered
2025-04-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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: Mineral Trioxide Aggregate: Treatment outcome of Mineral Trioxide Aggregate as pulpotomy agent in mature permanent molars with symptomatic irreversible pulpitis Control Intervention1: H

Sponsors

Dr Aditi Gaur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Systemically healthy patients between age group of 18 to 40 years with maxillary or mandibular mature permanent carious teeth with radiographic and clinical evidence of symptomatic irreversible pulpitis will be included in the study. Patient with history of spontaneous or lingering pain or nocturnal pain in relation to maxillary or mandibular molar. Healthy gingiva with no swelling or sinus tract. Active bleeding pulp tissue observed upon access opening and in all canals after full pulpotomy and hemostasis achieved within 5 min following full pulpotomy. Radiographic evaluation showing a periapical index PAI of less than 3 A written informed consent will be taken from all the patients and only those patients ready to sign the consent form, willing to participate and come for multiple visits for follow-up will be included in the study.

Exclusion criteria

Exclusion criteria: Teeth which are non-restorable, necrosed, badly broken or with developmental anomalies, heavy occlusal load, cracks or vertical root fractures will be excluded. Teeth with negative pulp sensibility test will be excluded. Teeth which are periodontally compromised, present with localized gum swelling or showing evidence of sinus tracts, pus discharge and weeping canals will be excluded. Radiographic evidence of peri or inter radicular lesions, internal or external root resorption, open apex or pulp stone in pulp chamber will be excluded from the study. Pregnant and lactating women will be excluded. Intraoperative Evaluation - If the remaining pulpal tissue displayed a pale yellow, dark brown, or reddish coloration, it will be excluded.

Design outcomes

Primary

MeasureTime frame
Results of the study will help us to know that which material clinically performs better between Mineral Trioxide Aggregate, Human Amniotic Membrane and Bio-C Repair in a permanent molar with symptomatic irreversible pulpitisTimepoint: Follow up at baseline, 24 hours, 2 weeks, 6 months and 12 months will be done.

Secondary

MeasureTime frame
PAI INDEX will be assessed and be calculated as follows 1-Normal periapical anatomy 2-Mild changes in bone pattern 3-Changes in bone pattern with diffuse loss of mineral 4-Apical Periodontitis with definite radiolucency in the periapical area 5-Severe periodontitis with features of exacerbation. Timepoint: Baseline, 24 hours, 2 weeks, 6 months and 12 months

Countries

India

Contacts

Public ContactDr Ajay Singh Rao

K M Shah Dental College and Hospital

drajayinendo@gmail.com8385017307

Outcome results

None listed

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