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A comparative clinical and radiological evaluation of pulp capping agents in permanent teeth with carious pulp exposure – an in-vivo study.

A comparative clinical and radiological evaluation of biodentine, platelet-rich fibrin, and acemannan as direct pulp capping agent in permanent teeth with various pulp exposure – an in-vivo study. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/077953
Enrollment
45
Registered
2024-12-11
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: K025- Dental caries on pit and fissure surface

Interventions

Intervention1: BIODENTINE : BIODENTIN Will be used as pulp capping agent once based on size of pulp exposure Control Intervention1: Acemannan: It’s extracted from aloe vera by the alcohol precipitati

Sponsors

Manoj M Dhavalagi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Patients willing to participate in the study. • Both males and females will be included within the age group of 18-35 years. • Posterior tooth with a deep carious lesion with no pain and swelling for the involved tooth. • Any tooth positive response to vitality testing (electric pulp tests and cold test), the response should be comparable to the contralateral tooth. • Tooth responding negative to percussion test. • Tooth with carious pulpal exposure not larger than 2 mm in diameter with mild symptoms and normal periapical tissues (Periapical index score =2) • The bleeding from exposed pulp which can be resolved within less than five minutes. • Tooth which could be restored with composite, amalgam, and stainless stain crown (restorable tooth structure).

Exclusion criteria

Exclusion criteria: • Teeth with large caries exposure with symptoms (Teeth associated with pain and presence of soft tissue swelling or abscess in relation to involved teeth.) • Teeth with Uncontrolled bleeding during caries removal. • Teeth with cracks and defects and traumatic pulp exposure. • Presence of signs and symptoms of irreversible pulpitis and periapical pathologies. • Teeth that cannot be isolated with a rubber dam. • Teeth with low prognosis which includes abnormal mobility. (Miller’s classification grade II and grade III) • Presence of pulp canal obliteration or calcification. • Evidence of internal and external root resorption. • Pregnant and lactating mothers.

Design outcomes

Primary

MeasureTime frame
To evaluate the clinical and radiological outcomes of direct pulp capping using Biodentin, Platelet Rich Fibrin, and Acemannan in cariously exposed vital permanent teeth.Timepoint: 6 months

Secondary

MeasureTime frame
•To evaluate the clinical and radiological outcome of direct pulp capping using Biodentine in cariously exposed vital permanent teeth. •To evaluate the clinical and radiological outcome of direct pulp capping using Platelet Rich Fibrin in cariously exposed vital permanent teeth. •To evaluate the clinical and radiological outcome of direct pulp capping using Acemannan in cariously exposed vital permanent teeth. •To compare the above three groups. Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Manoj M Dhavalagi

K V G Dental College and Hospital

moksha.nayak@gmail.com9448026828

Outcome results

None listed

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