MedPath

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

Phase 4
Conditions
Health Condition 1: 4- Measurement and Monitoring
Registration Number
CTRI/2023/08/056824
Lead Sponsor
AIIMS Bathinda
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
(1) rapid formation of a hard tissue bridge to protect the pulp from other stimuli, <br/ ><br>(2) formation of a barrier that prevents secondary pulp infections, & <br/ ><br>(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 <br/ ><br>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 Outcome Measures
NameTimeMethod
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.
© Copyright 2025. All Rights Reserved by MedPath