Clinical trial NCT06435065: Direct Pulp Capping Agent on Human Pulp Tissue
Official title: Histological and Radiographic Evaluation of the Effects of Direct Pulp Capping Agent on Human Pulp Tissue
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Reversible Pulpitis
Keywords: DIRCT PULP CAPPING
Biodentine
MTA
TheraCal LC
Tristrontium Aluminate
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: RADIOGRAPHIC EVALUATION OF FOUR DIRECT PULP CAPPING MATERIALS ON HUMAN PULP TISSUE
timeFrame: 90 DAYS
measure: HISTOLOGICAL EVALUATION OF FOUR DIRECT PULP CAPPING MATERIALS ON HUMAN PULP TISSUE
timeFrame: 90 DAYS
Secondary outcomes:
Other outcomes:
Locations:
city: Ambāla
country: India
facility: Swati
state: Haryana
Study officials:
affiliation: professor
name: surinder sachdeva, mds
role: STUDY_DIRECTOR
References:
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.
citation: 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.