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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06435065
Other study ID # 2264
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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