Direct Pulp Capping Agent on Human Pulp Tissue

Last updated: May 23, 2024
Sponsor: DR SURINDER SACHDEVA
Overall Status: Active - Recruiting

Phase

4

Condition

Acute And Chronic Dental Pain

Treatment

THERACAL LC

Biodentine

Mineral Tri-Oxide Aggregate

Clinical Study ID

NCT06435065
2264
  • Ages 15-25
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

INCLUSION CRITERIA:

  • CARIES-free, undamaged mature maxillary and mandibular premolars that were plannedfor 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

EXCLUSION CRITERIA:

  • caries are present

  • Teeth with signs and symptoms of irreversible pulpitis, such as nighttime severepain

  • 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 bonedestruction

  • and/or calcifications in the pulp chamber or canals.

  • Medically compromised patient.

  • Pregnant patient.

Study Design

Total Participants: 40
Treatment Group(s): 4
Primary Treatment: THERACAL LC
Phase: 4
Study Start date:
April 01, 2024
Estimated Completion Date:
July 31, 2024

Study 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

Connect with a study center

  • Swati

    Ambāla, Haryana 133207
    India

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.