Direct Pulp Capping Agent on Human Pulp Tissue

NCT06435065 | Recruiting Phase 4

• 1 other identifier: 2264
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Reversible Pulpitis

Keywords

DIRCT PULP CAPPING; Biodentine; MTA; TheraCal LC; Tristrontium Aluminate

Outcome Measures

Primary Outcomes (2)

• RADIOGRAPHIC EVALUATION OF FOUR DIRECT PULP CAPPING MATERIALS ON HUMAN PULP TISSUE

  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

  Histological examination of the extracted teeth will be done after 90 days and evidence of dentinal bridge formation will be evaluated microscopically

  90 DAYS

Study Arms (4)

BIODENTINE

SHAM COMPARATOR

DIRECT PULP CAPPING WILL BE DONE USING BIODENTINE AS DIRECT PULP CAPPING AGENT

Drug: Biodentine

MINERAL TRIOXIDE AGGREGATE

SHAM COMPARATOR

DIRECT PULP CAPPING WILL BE DONE USING MTA AS DIRECT PULP CAPPING AGENT

Drug: Mineral Tri-Oxide Aggregate

THERACAL LC

SHAM COMPARATOR

DIRECT PULP CAPPING WILL BE DONE USING THERACAL LC AS DIRECT PULP CAPPING AGENT

Drug: THERACAL LC

TRISTRONTIUM ALUMINATE

ACTIVE COMPARATOR

DIRECT PULP CAPPING WILL BE DONE USING TRISTRONTIUM ALUMINATE AS DIRECT PULP CAPPING AGENT

Drug: TRISTRONTIUM ALUMINATE

Interventions

Biodentine DRUG

DIRECT PULP CAPPINGWILL BE DONE USING BIODENTINE

BIODENTINE

Mineral Tri-Oxide Aggregate DRUG

DIRECT PULP CAPPINGWILL BE DONE USING MTA

Also known as: MTA

MINERAL TRIOXIDE AGGREGATE

THERACAL LC DRUG

DIRECT PULP CAPPINGWILL BE DONE USING THERACAL LC

THERACAL LC

TRISTRONTIUM ALUMINATE DRUG

DIRECT PULP CAPPINGWILL BE DONE USING TRISTRONTIUM ALUMINATE

TRISTRONTIUM ALUMINATE

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DR SURINDER SACHDEVA: lead

Study Sites (1)

Swati

Ambāla, Haryana, 133207, India

RECRUITING

Related Publications (2)

• Parolia A, Kundabala M, Rao NN, Acharya SR, Agrawal P, Mohan M, Thomas M. A comparative histological analysis of human pulp following direct pulp capping with Propolis, mineral trioxide aggregate and Dycal. Aust Dent J. 2010 Mar;55(1):59-64. doi: 10.1111/j.1834-7819.2009.01179.x.

  PMID: 20415913 BACKGROUND

• Nowicka A, Lipski M, Parafiniuk M, Sporniak-Tutak K, Lichota D, Kosierkiewicz A, Kaczmarek W, Buczkowska-Radlinska J. Response of human dental pulp capped with biodentine and mineral trioxide aggregate. J Endod. 2013 Jun;39(6):743-7. doi: 10.1016/j.joen.2013.01.005. Epub 2013 Apr 10.

  PMID: 23683272 BACKGROUND

MeSH Terms

Interventions

tricalcium silicate; TheraCal; Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• surinder sachdeva, mds

  professor

  STUDY DIRECTOR

Central Study Contacts

swati chhabra, MDS

CONTACT

7015070095; drswatichhabra@gmail.com

navneet kukreja, MDS

CONTACT

9416028633; navneetkukrejaendo@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: periodontist

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 30, 2024
• Study Start: April 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

IN (1)