Comparative analysis of Mineral Trioxide Aggregate with Chitosan and Platelet Rich Fibrin for Preserving Tooth Vitality in Adults with Carious Exposure.

Efficacy of Mineral Trioxide Aggregate with Chitosan and Platelet Rich Fibrin as Scaffold for Pulp Capping in Vital Pulp Therapy of Permanent Mature Teeth with Carious Exposure- A Randomized Control Trail. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/109490

Enrollment

Registered

2026-04-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: 1)Mineral Trioxide Aggregate with Chitosan. 2)Mineral Trioxide Aggregate (MTA)with Platelet-Rich Fibrin (PRF).: 1)After achieving hemostasis following carious pulp exposure, a sterile

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 60 years willing to participate and provide written informed consent. 2. Mature permanent teeth with fully formed roots and closed apices. 3. Teeth presenting with carious pulp exposure diagnosed clinically during caries removal. 4. Teeth showing signs of reversible pulpitis or early symptomatic pulpitis (no spontaneous lingering pain). 5. Positive vitality tests (cold test). 6. Homeostasis achievable within 5 minutes after pulp exposure using sterile 2.5 percent NaOCl. 7. Teeth that are restorable with an appropriate permanent restoration after the procedure. 8. Preoperative radiograph showing normal periapical periodontium (no radiolucency, no root resorption). 9. Teeth exhibiting no mobility, no sinus tract, and no periodontal pocket more than 4 mm. 10. Patients who are medically healthy (ASA I or II) without systemic conditions affecting healing.

Exclusion criteria

Exclusion criteria: 1. Teeth diagnosed with irreversible pulpitis (lingering spontaneous pain) or pulp necrosis (negative vitality tests). 2. Presence of periapical radiolucency, root resorption, widened PDL space, or any radiographic sign of periapical pathology. 3. Teeth with purulent, necrotic, or uncontrollable bleeding from the pulp exposure (hemostasis not achievable within 5 minutes). 4. Teeth that are non-restorable due to extensive structural loss, cervical caries, or subgingival fractures. 5. Presence of sinus tract, swelling, or abscess associated with the affected tooth. 6. Teeth with advanced periodontal disease (mobility more than Grade I or probing depth more than 4 mm). 7. Patients with systemic conditions that may impair healing (uncontrolled diabetes, immunosuppression, bleeding disorders, bisphosphonate therapy, etc.). 8. Patients who have taken antibiotics or corticosteroids within the past 7 days. 9. Pregnant or lactating women. 10. Patients with a history of allergy to study materials (Biodentine components, chitosan, etc.). 11. Teeth previously treated endodontically or with previous pulp capping or pulpotomy procedures. 12. Immature permanent teeth with open apices.

Design outcomes

Primary

Measure	Time frame
To evaluate the clinical and radiographic success of vital pulp therapy, defined by maintained pulp vitality, absence of pain or swelling, and evidence of a continuous mineralized dentin bridge at the exposure siteTimepoint: 1week 3,6,12 months	—

Secondary

Measure	Time frame
nilTimepoint: nil	—

Countries

India

Contacts

Public ContactDr Rohit Kocharr

I.T.S Dental College,Hospital and Research and Centre

hod.cons.gn@its.edu.in9810034451

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026