Direct Pulp Capping Agent on Human Pulp Tissue

Reversible Pulpitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06435065
• Other study ID #: 2264
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2024
• Est. completion date: July 2024

Study information

• Verified date: May 2024
• Source: Maharishi Markendeswar University (Deemed to be University)
• Contact: swati chhabra, MDS
• Phone: 7015070095
• Email: drswatichhabra[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis
• Reversible Pulpitis

Intervention

Drug:
• Biodentine
DIRECT PULP CAPPINGWILL BE DONE USING BIODENTINE
• Mineral Tri-Oxide Aggregate
DIRECT PULP CAPPINGWILL BE DONE USING MTA
• THERACAL LC
DIRECT PULP CAPPINGWILL BE DONE USING THERACAL LC
• TRISTRONTIUM ALUMINATE
DIRECT PULP CAPPINGWILL BE DONE USING TRISTRONTIUM ALUMINATE

Locations

Country	Name	City	State
India	Swati	Ambala	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
DR SURINDER SACHDEVA

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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