Assessment of clinical and radiological effectiveness of inert collagen sponge saturated by Proanthocyanidin and Polyamidoamine calcium phosphate nanoparticles as a biomaterial on indirect pulp capping compared with MTA in Primary teeth: A Randomized Clinical Trial

Assessment of clinical and radiological effectiveness of inert collagen sponge saturated by Proanthocyanidin and Polyamidoamine calcium phosphate nanoparticles as a biomaterial on indirect pulp capping compared with MTA in Primary teeth: A Randomized Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/076071

Enrollment

Registered

2024-10-30

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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 Health Condition 2: K029- Dental caries, unspecified

Interventions

Intervention1: proanthocyanidin with polyamidoamine calcium phosphate nanoparticles as indirect pulp capping biomaterial: assessment of clinical and radiological effectiveness of inert collagen sponge

Eligibility

Inclusion criteria

Inclusion criteria: 1.Teeth with active deep caries on the occlusal or proximal surfaces with a history of dull, reversible pain, or mild discomfort on chewing were included in the study. 2. On radiographic interpretation, caries depth should be greater than two-third of dentin thickness approaching pulp with no radiolucency in the periapical or furcation area of the teeth are included in the study

Exclusion criteria

Exclusion criteria: 1.Patients with systemic diseases 2.uncooperative child 3. Teeth exhibiting signs of irreversible pulpitis such as spontaneous pain, pain on percussion, mobility, sinus tract, abscess, widened periodontal spaces, interrupted lamina dura, pulp involvement, or radiographic evidence of periapical or furcational radiolucency.

Design outcomes

Primary

Measure	Time frame
The primary outcome of the trial is to assess the clinical success (absence of pain, infection, or symptoms) and radiological success (no radiolucency, root resorption, or abnormal development) of an inert collagen sponge saturated with Proanthocyanidin and Polyamidoamine calcium phosphate nanoparticles compared to MTA for indirect pulp capping in primary teeth.Timepoint: baseline,3 months, 6 months	—

Measure

Time frame

The primary outcome of the trial is to assess the clinical success (absence of pain, infection, or symptoms) and radiological success (no radiolucency, root resorption, or abnormal development) of an inert collagen sponge saturated with Proanthocyanidin and Polyamidoamine calcium phosphate nanoparticles compared to MTA for indirect pulp capping in primary teeth.Timepoint: baseline,3 months, 6 months

—

Secondary

Measure	Time frame
The secondary outcomes of the trial include evaluating pulp vitality, dentin bridge formation, and the survival rate of treated teeth, along with any inflammatory response and patient-reported outcomes such as discomfort or satisfaction. Timepoint: baseline,3 months, 6 months	—

Countries

India

Contacts

Public ContactDr Punit Fulzele

Sharad Pawar Dental college and Hospital, DMIHER

punitr007@gmail.com9890417646

Outcome results

None listed

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