Clinical trial NCT04773886: Effectiveness of Mineral Trioxide Aggregate and Platelet Rich Fibrin Along With Biodentine. .
Official title: To Evaluate the Effectiveness of Mineral Trioxide Aggregate and Platelet Rich Fibrin Along With Biodentine as Pulpotomy Medicament in Patients With Pulpitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulpitis - Irreversible
Keywords: pulpal regeneration
pulpitis
pulpotomy
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sixty systemically healthy patients with irreversible pulpitis were enrolled in the study based on inclusion and exclusion criteria. All the enrolled patients were randomly allocated into 4 groups (15 each)

Group I: MTA GROUP: Vital Pulpotomy will be done using Mineral trioxide aggregate (MTA) as pulp capping agent. Group II: BIODENTINE GROUP: Vital Pulpotomy will be done using Biodentine as pulp capping agent. Group III: PRF + MTA GROUP: Vital Pulpotomy will be done using PRF and Mineral trioxide aggregate (MTA) as pulp capping agent. Group IV: PRF+ BIODENTINE GROUP: Vital Pulpotomy will be done using PRF and Biodentine as pulp capping agent.
Primary purpose: TREATMENT

Brief summary: The aim of this study was to clinically and radiographically evaluate the effectiveness of MTA, Biodentine, Platelet Rich Fibrin along with Mineral Trioxide Aggregate and Platelet Rich Fibrin along with Biodentine as pulpotomy medicament in patients with pulpitis.

Detailed description: Sixty systemically healthy patients with irreversible pulpitis were enrolled in the study based on inclusion and exclusion criteria. All the enrolled patients were randomly allocated into 4 groups (15 each)

Group I: MTA GROUP: Vital Pulpotomy will be done using Mineral trioxide aggregate (MTA) as pulp capping agent. Group II: BIODENTINE GROUP: Vital Pulpotomy will be done using Biodentine as pulp capping agent. Group III: PRF + MTA GROUP: Vital Pulpotomy will be done using PRF and Mineral trioxide aggregate (MTA) as pulp capping agent. Group IV: PRF+ BIODENTINE GROUP: Vital Pulpotomy will be done using PRF and Biodentine as pulp capping agent Patients were assessed at 1 day,3 months, 6 months and 9 months postoperatively for pain, pulp sensitivity test, swelling or presence of any sinus tract. All the proposed teeth were assessed radiographically at1 day, 3 months, 6 months and 9 months postoperatively.

Eligibility criteria: Inclusion Criteria:

* Patients with carious exposed tooth exhibiting clinical and radiographical evidence for pulpitis.
* Deep caries extending ≥2/3 of dentin.
* Tooth with positive response with cold testing.
* Tooth with no mobility.
* No signs of pulpal necrosis including sinus tract or swelling.
* Patient approval for the treatment and follow up

Exclusion Criteria:

* Any systemic disease that could influence the outcome.
* Non-restorable tooth.
* Teeth with periapical widening.
* Tooth which cannot be isolated.
* Teeth with marginal periodontitis or crestal bone loss.
* Indication of post/ post and core restoration marginal periodontitis with attachment loss \>5mm.
* Teeth with immature root or calcified canal.
* Teeth with internal and external resorption.
* No pulp exposure after caries excavation.
* Uncontrolled bleeding after access cavity preparation after several minutes N
* No bleeding at all at the time of access opening
* Pregnant or nursing women.
* Individual hypersensitive or allergic to any product used in the study

Primary outcomes:
measure: EPT
timeFrame: change from baseline to 1day, 3 months, 6 months, 9 months
measure: cold test
timeFrame: change from baseline to 1day, 3 months, 6 months, 9 months
Secondary outcomes:
measure: Tender on percussion
timeFrame: change from baseline to 1day, 3 months, 6 months, 9 months
measure: swelling
timeFrame: change from baseline to 1day, 3 months, 6 months, 9 months
Other outcomes:
Locations:
city: Ambāla
country: India
facility: Department of Conservative Dentistry and Endodontics, M.M. College of Dental Sciences and Research.
state: Haryana
Study officials:
affiliation: PROFESSOR
name: surinder sachdeva, M.D.S.
role: STUDY_DIRECTOR
References:
citation: Li Y, Sui B, Dahl C, Bergeron B, Shipman P, Niu L, Chen J, Tay FR. Pulpotomy for carious pulp exposures in permanent teeth: A systematic review and meta-analysis. J Dent. 2019 May;84:1-8. doi: 10.1016/j.jdent.2019.03.010. Epub 2019 Apr 11.
citation: Kumar V, Juneja R, Duhan J, Sangwan P, Tewari S. Comparative evaluation of platelet-rich fibrin, mineral trioxide aggregate, and calcium hydroxide as pulpotomy agents in permanent molars with irreversible pulpitis: A randomized controlled trial. Contemp Clin Dent. 2016 Oct-Dec;7(4):512-518. doi: 10.4103/0976-237X.194107.