Skip to content

Direct Pulp Capping Agent on Human Pulp Tissue

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06435065
Enrollment
40
Registered
2024-05-30
Start date
2024-04-01
Completion date
2024-07-31
Last updated
2024-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reversible Pulpitis

Keywords

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

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.

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

Interventions

DRUGBiodentine

DIRECT PULP CAPPINGWILL BE DONE USING BIODENTINE

DIRECT PULP CAPPINGWILL BE DONE USING MTA

DIRECT PULP CAPPINGWILL BE DONE USING THERACAL LC

DRUGTRISTRONTIUM ALUMINATE

DIRECT PULP CAPPINGWILL BE DONE USING TRISTRONTIUM ALUMINATE

Sponsors

DR SURINDER SACHDEVA
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
15 Years to 25 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
RADIOGRAPHIC EVALUATION OF FOUR DIRECT PULP CAPPING MATERIALS ON HUMAN PULP TISSUE90 DAYSradiographic 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
HISTOLOGICAL EVALUATION OF FOUR DIRECT PULP CAPPING MATERIALS ON HUMAN PULP TISSUE90 DAYSHistological examination of the extracted teeth will be done after 90 days and evidence of dentinal bridge formation will be evaluated microscopically

Countries

India

Contacts

Primary Contactswati chhabra, MDS
drswatichhabra@gmail.com7015070095
Backup Contactnavneet kukreja, MDS
navneetkukrejaendo@gmail.com9416028633

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026