Direct Pulp Capping Agent on Human Pulp Tissue

DR SURINDER SACHDEVA

Status and phase: Enrolling; Phase 4

Conditions: Reversible Pulpitis

Treatments: Drug: TRISTRONTIUM ALUMINATE; Drug: THERACAL LC; Drug: Biodentine; Drug: Mineral Tri-Oxide Aggregate

Study type: Interventional

Funder types: Other

Identifiers

NCT06435065

2264

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 15 to 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups

BIODENTINE

Sham Comparator group

Description:

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

Treatment:

Drug: Biodentine

MINERAL TRIOXIDE AGGREGATE

Sham Comparator group

Description:

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

Treatment:

Drug: Mineral Tri-Oxide Aggregate

THERACAL LC

Sham Comparator group

Description:

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

Treatment:

Drug: THERACAL LC

TRISTRONTIUM ALUMINATE

Active Comparator group

Description:

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

Treatment:

Drug: TRISTRONTIUM ALUMINATE