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Comparative Evaluation of Human Amniotic Membrane and Bio Ceramic Material for Direct Pulp Capping in Mature Permanent Teeth: A Randomized Clinical Trial with Cone Beam Computed Tomography Analysis

To evaluate & compare Direct Pulp Capping using Human Amniotic membrane (HAM) & Bio Ceramic Material (BCM) in mature permanent teeth with adjunct of Cone Beam Computed Tomography (CBCT): Randomized Clinical Trial - Vital Pulp Therapy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056824
Enrollment
107
Registered
2023-08-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: 4- Measurement and Monitoring

Interventions

Intervention1: evaluate and compare Direct Pulp Capping using Human Amniotic membrane (HAM) and Bio Ceramic Material (BCM) in mature permanent teeth with adjunct of Cone Beam Computed Tomography (CBCT

Sponsors

AIIMS Bathinda
Lead Sponsor
AIIMS Bathinda
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria 1. All participants who give consent to be part of this study and are cooperative with no underlying medical, physical or learning disabilities. 2. Absence of any clinical signs and symptoms of pulp degeneration such as a history of spontaneous pain, pain on percussion, swelling, pathological mobility, or sinus tract. 3. Mechanical pulp exposure is larger than pinpoint. 4. Caries should be bilaterally present in the oral cavity. 5. Radiographically carious lesion approximating the pulp. 6. The recruited molars should have a normal radiographic appearance with healthy supporting tissues. 7. No evidence of pathological root resorption (external and/or internal), widening of periodontal ligament (PDL), and periapical or furcal radiolucency.

Exclusion criteria

Exclusion criteria: Exclusion Criteria 1. Participants who don’t give consent to participate in the study. 2. Children aged below 14 years. 3. History of any medical complication occurred while performing dental procedure. 4. Participants not having the condition bilaterally.

Design outcomes

Primary

MeasureTime frame
(1) rapid formation of a hard tissue bridge to protect the pulp from other stimuli, (2) formation of a barrier that prevents secondary pulp infections, & (3) induction of hard tissue formation at the interface to avoid obliteration of the pulpTimepoint: Clinical & Radiological Evaluation of Tooth at Day 1, 3 Months, 6 Months, 12 months Pulp capped teeth will be subjected to CBCT evaluation at 3 month interval, using NewTom GiANO HR 3D CEPH - CBCT Machine, with small field of view (FOV) of 5×5 cm, ultra high resolution of 90µm, 75kV, 4 mA, 20 seconds exposure time , 350 mGycm2.

Secondary

MeasureTime frame
There is no difference in clinical & radiological effectiveness of using Human Amniotic membrane and Bio-ceramic materials for Direct Pulp Capping in Mature Permanent Teeth at Day 1, 3 Months, 6 Months and 12 Months duration.Timepoint: There is a difference in clinical & radiological effectiveness of using Human Amniotic membrane and Bio-ceramic materials for Direct Pulp Capping in Mature Permanent Teeth at 1 day, 3 months, 6 months and 12 months duration.

Countries

India

Contacts

Public ContactDr Tarun Kumar Singh

AIIMS, Bathinda

drtarunkumarsingh@gmail.com9560627466

Outcome results

None listed

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