Direct Pulp Capping Agent on Human Pulp Tissue

May 23, 2024 updated by: DR SURINDER SACHDEVA

Histological and Radiographic Evaluation of the Effects of Direct Pulp Capping Agent on Human Pulp Tissue

This in- vivo study was conducted to evaluate the response of human pulp tissue following direct pulp capping using four different pulp capping agents in premolars scheduled for extraction in patients undergoing orthodontic treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

For the study 40 premolars from patients in the age group of 15-25 years, undergoing orthodontic treatment, in the Department of Orthodontics, MMCDSR, Mullana, Ambala, who had to get their premolars extracted as per their orthodontic treatment plan will be selected.

Only healthy premolars, with no caries, showing no signs and symptoms of pulpitis or periodontal diseases were selected. Medically compromised patients, or teeth with radiographic findings of external/internal resorption, bone loss, or calcifications in the pulp chamber will be excluded from the study. The selected premolars were then randomly divided into four equal groups namely: GROUP I - Direct pulp capping procedure performed using Biodentine. GROUP II - Direct pulp capping procedure performed using MTA. GROUP III - Direct pulp capping procedure performed using TheraCal LC. GROUP IV - Direct pulp capping procedure performed using Tristrontium aluminate.

The direct pulp capping procedure was carried out under rubber dam. The study protocol included class I cavity preparations on the premolars, followed by iatrogenic exposure of the pulp (0.5mm) using a sterile round bur, placement of the direct pulp capping agent according to the material of allotted to the study group. The teeth were permanently restored on the same visit, except for MTA group were the teeth were temporarily restored using Cavit G, and recalled after 1 day for permanent restoration. The patients were then enquired for any 94 SUMMARY 95 symptoms at 1 day and 7 days post operatively. The teeth were then, atraumatically extracted 3 months after the procedure. The extracted teeth were then put to CBCT as well as histopathological examination. Through CBCT evaluation, the completeness of the dentine bridge was evaluated. Histopathological examination was done to examine the pulpal response and the quality of the dentine bridge formed

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Haryana
      • Ambāla, Haryana, India, 133207
        • Recruiting
        • Swati
        • Contact:
          • swati chhabra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

INCLUSION CRITERIA:

  • CARIES-free, undamaged mature maxillary and mandibular premolars that were planned for extraction for orthodontic reasons.
  • Teeth that show no reaction to percussion.
  • Teeth with no previous restorations.
  • Teeth that show vitality, when checked with an electric pulp tester.
  • Teeth that show no signs of caries or periapical pathology when examined
  • radiographically.
  • Fully erupted teeth, that allowed proper application of rubber dam.

EXCLUSION CRITERIA:

  • caries are present
  • Teeth with signs and symptoms of irreversible pulpitis, such as nighttime severe pain
  • or spontaneous pain.
  • Teeth that show sensitivity to hot and/or cold.
  • Radiographic examination reveals any signs of caries, periapical pathology,
  • internal/external root resorption, furcal radiolucency/ inter-radicular bone destruction
  • and/or calcifications in the pulp chamber or canals.
  • Medically compromised patient.
  • Pregnant patient.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: BIODENTINE
DIRECT PULP CAPPING WILL BE DONE USING BIODENTINE AS DIRECT PULP CAPPING AGENT
Drug: Biodentine
DIRECT PULP CAPPINGWILL BE DONE USING BIODENTINE
Sham Comparator: MINERAL TRIOXIDE AGGREGATE
DIRECT PULP CAPPING WILL BE DONE USING MTA AS DIRECT PULP CAPPING AGENT
Drug: Mineral Tri-Oxide Aggregate
DIRECT PULP CAPPINGWILL BE DONE USING MTA
Other Names:
  • MTA
Sham Comparator: THERACAL LC
DIRECT PULP CAPPING WILL BE DONE USING THERACAL LC AS DIRECT PULP CAPPING AGENT
Drug: THERACAL LC
DIRECT PULP CAPPINGWILL BE DONE USING THERACAL LC
Active Comparator: TRISTRONTIUM ALUMINATE
DIRECT PULP CAPPING WILL BE DONE USING TRISTRONTIUM ALUMINATE AS DIRECT PULP CAPPING AGENT
Drug: TRISTRONTIUM ALUMINATE
DIRECT PULP CAPPINGWILL BE DONE USING TRISTRONTIUM ALUMINATE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RADIOGRAPHIC EVALUATION OF FOUR DIRECT PULP CAPPING MATERIALS ON HUMAN PULP TISSUE
Time Frame: 90 DAYS
radiographic examination will be done after 90 days and presence or absence of secondary dentin formation and completeness of the dentinal bride formed will be evaluated by CBCT
90 DAYS
HISTOLOGICAL EVALUATION OF FOUR DIRECT PULP CAPPING MATERIALS ON HUMAN PULP TISSUE
Time Frame: 90 DAYS
Histological examination of the extracted teeth will be done after 90 days and evidence of dentinal bridge formation will be evaluated microscopically
90 DAYS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DR SURINDER SACHDEVA

Investigators

  • Study Director: surinder sachdeva, mds, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2264

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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