A COMPARATIVE EVALUATION OF VARIOUS BIO-MATERIALS AS PULPOTOMY AGENTS IN MATURE PERMANENT MOLARS WITH IRREVERSIBLE PULPITIS- AN IN VIVO STUDY
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- •The aim of this study will be to evaluate the success of pulpotomy in mature permanent molars with irreversible pulpitis using different bio-materials based on clinical and radiographical analysis.
Study Overview
Brief Summary
The purpose of this in-vivo study will be to compare the various bio-materials as pulpotomy agents in mature permanent molars with irreversible pulpitis.
â— Adequate number of patients will be selected by following the proper inclusion and exclusion criteria.
â— After the tooth has been properly diagnosed and tested to fall under inclusion criteria, an informed consent will be obtained from the patient.
â— After giving local anesthesia, tooth will be isolated using rubber dam.
â— Using sterile round bur in high speed air-rotor hand piece along with copious irrigation, caries will be removed and pre-endodontic build up will be done, followed by an access cavity.
â— The coronal pulp will be removed till the level of orifices using sterile sharp spoon excavator and copious irrigation with saline.
â— Bleeding will be controlled using 5% sodium hypochlorite on a cotton pellet.
â— After the haemostasis, the pulp chamber will be filled with allocated material, followed by temporary restoration.
â— First baseline follow-up will be done after 24 hours, followed second follow-up after 7 days.
â— After 2 weeks, if the symptomatic improvement is seen, the temporary restoration will be replaced by post-endodontic restoration.
â— The follow-up of the patient will also be done after 3 months, 6 months and 12 months, noting down the clinical symptoms and the radiographic changes.
â— The results obtained will be compared and subjected to statistical analysis.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 15.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient age should be between 15-60 with no contributory medical history.
- •Deep caries with subsequent pulp exposure in a permanent molar tooth.
- •The tooth should respond to pulp vitality tests.
- •Pulp tissue bleeding should be present in all canals after entering the chamber.
- •Teeth with symptomatic irreversible pulpitis without periapical involvement.
- •Tooth should be restorable .
- •Hemostasis should be achieved after complete pulpotomy.
Exclusion Criteria
- •Deciduous teeth.
- •Teeth with deformities, cracks, fractures and restorations, active disease, moderate/severe periodontal disease, root resorption, root canal calcification.
- •Teeth associated with abscess or sinus formation.
- •Pregnant or breast feeding woman.
Outcomes
Primary Outcomes
•The aim of this study will be to evaluate the success of pulpotomy in mature permanent molars with irreversible pulpitis using different bio-materials based on clinical and radiographical analysis.
Time Frame: in the time frame of 6 months (after the pulpotomy) this study will evaluate the success of pulpotomy in mature permanent molars with irreversible pulpitis using different bio-materials based on clinical and radiographical analysis.
Secondary Outcomes
- to Assess the effectiveness of each bio-material as pulpotomy agents.(To compare the success rate of different bio-materials (Mineral Trioxide Aggregate, Biodentin, EndoSequence root repair material, Bio-C repair putty material) used as pulpotomy agents.)