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Effectiveness of a Peptide Based Material in Preserving Tooth Pulp in patients with Deep Dental caries

Exploring the Role of Self-Assembling Peptide in Vital Pulp Therapy - A Randomized Control trial - Self -Assembling peptide-Vital Pulp Therapy trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099563
Enrollment
90
Registered
2025-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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: Self-Assembling Peptide: Patients allocated to this group will undergo vital pulp therapy using a self-assembling peptide. After rubber dam isolation and caries removal, standard vital

Sponsors

Council of Science & Technology U.P
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients must be between 18 to 45 years of age, ensuring cooperation with the study protocol. 2. Teeth with deep caries resulting in pulp exposure. 3. Reversible pulpitis or early symptomatic irreversible pulpitis (with controllable bleeding). 4. Both immature permanent teeth (to preserve root development) and mature permanent teeth (to maintain vitality). 5. Accidental pulp exposure during cavity preparation or caries excavation in a vital tooth. 6. Small, clean, recent exposure less than 1 mm, minimal contamination). 7. Vital pulp exposure due to trauma (fracture). 8. Particularly in immature permanent teeth where root apex is still open. 9. Teeth with pulp exposure due to caries but vital pulp confirmed. 10. Patients must provide informed consent and agree to attend all follow-up appointments as per the study timeline.

Exclusion criteria

Exclusion criteria: 1. Tooth has necrotic pulp. 2. Uncontrollable bleeding from pulp after exposure more than 5â??10 min. 3. Signs of acute infection (abscess, sinus tract). 4. Tooth is non-restorable. 5. Patient with systemic contraindications to pulp therapy. 6. Patients unwilling or unable to comply with the follow-up schedule. 7. Patient who does not give written informed consent.

Design outcomes

Primary

MeasureTime frame
Clinical Assessment: Clinical assessment of pain, tenderness, swelling, mobility, response to percussion or palpation & Tooth vitality using pulp vitality tests. Radiographic Assessment by CBCT: â?¢Formation of a continuous dentin bridge. â?¢ No Signs of periapical radiolucency, indicating the absence of pulpal or periapical pathology. Timepoint: Clinical outcome measured after 1 week, 6 and 12 months Radiographic outcomes measured after 6 month and 12 month

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactJyoti Jain

King George Medical University,Lucknow ,Uttar Pradesh

jyoti.jain@kgmcindia.edu08318395792

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026