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Effectiveness of Mineral Trioxide Aggregate and Platelet Rich Fibrin Along With Biodentine. .

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ClinicalTrials.gov Identifier: NCT04773886
Recruitment Status : Completed
First Posted : February 26, 2021
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
DR SURINDER SACHDEVA, Maharishi Markendeswar University (Deemed to be University)

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.

Condition or disease Intervention/treatment Phase
Pulpitis - Irreversible Drug: Mineral trioxide aggregate Drug: Biodentine Biological: Platelet rich fibrin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Double (Participant, Outcomes Assessor)
Masking Description: patient and statistician are masked about the treatment modality.
Primary Purpose: Treatment
Official Title: To Evaluate the Effectiveness of Mineral Trioxide Aggregate and Platelet Rich Fibrin Along With Biodentine as Pulpotomy Medicament in Patients With Pulpitis.
Actual Study Start Date : February 1, 2020
Actual Primary Completion Date : March 12, 2021
Actual Study Completion Date : March 12, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arm Intervention/treatment
Sham Comparator: MTA GROUP
Vital Pulpotomy will be done using Mineral trioxide aggregate(MTA) as pulp capping agent.
Drug: Mineral trioxide aggregate
Vital Pulpotomy will be done using Mineral trioxide aggregate (MTA) as pulp capping agent
Other Name: MTA

Sham Comparator: BIODENTINE GROUP
Vital Pulpotomy will be done using Biodentine as pulp capping agent.
Drug: Biodentine
Vital Pulpotomy will be done using Biodentine as pulp capping agent
Other Name: Biodenine

Active Comparator: PRF + MTA GROUP
Vital Pulpotomy will be done using PRF and Mineral trioxide aggregate (MTA) as pulp capping agent
Drug: Mineral trioxide aggregate
Vital Pulpotomy will be done using Mineral trioxide aggregate (MTA) as pulp capping agent
Other Name: MTA

Biological: Platelet rich fibrin

10 ml of blood was drawn from the peripheral vein in the selected patients with the help of sterilized disposable syringe and blood was collected in the pre-sterilized borosilicate glass test tube, without any addition of anticoagulant and was immediately centrifuged at 3000 rpm for 15 minutes in a centrifuge unit.

The product obtained after centrifugation consisted of three layers:

  • Acellular platelet plasma- top most layer
  • Platelet rich fibrin -middle layer
  • Red blood corpuscles- bottom layer PRF was then separated from the red blood corpuscles base with the help of sterile tweezers and scissors and squeezed with the help of sterile gauze piece

Active Comparator: PRF+ BIODENTINE GROUP
Vital Pulpotomy will be done using PRF and Biodentine as pulp capping agent.
Drug: Biodentine
Vital Pulpotomy will be done using Biodentine as pulp capping agent
Other Name: Biodenine

Biological: Platelet rich fibrin

10 ml of blood was drawn from the peripheral vein in the selected patients with the help of sterilized disposable syringe and blood was collected in the pre-sterilized borosilicate glass test tube, without any addition of anticoagulant and was immediately centrifuged at 3000 rpm for 15 minutes in a centrifuge unit.

The product obtained after centrifugation consisted of three layers:

  • Acellular platelet plasma- top most layer
  • Platelet rich fibrin -middle layer
  • Red blood corpuscles- bottom layer PRF was then separated from the red blood corpuscles base with the help of sterile tweezers and scissors and squeezed with the help of sterile gauze piece




Primary Outcome Measures :
  1. EPT [ Time Frame: change from baseline to 1day, 3 months, 6 months, 9 months ]
    Electric pulp testing

  2. cold test [ Time Frame: change from baseline to 1day, 3 months, 6 months, 9 months ]
    cold test


Secondary Outcome Measures :
  1. Tender on percussion [ Time Frame: change from baseline to 1day, 3 months, 6 months, 9 months ]
    present or absent

  2. swelling [ Time Frame: change from baseline to 1day, 3 months, 6 months, 9 months ]
    present or absent



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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04773886


Locations
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India
Department of Conservative Dentistry and Endodontics, M.M. College of Dental Sciences and Research.
Ambāla, Haryana, India, 133207
Sponsors and Collaborators
Maharishi Markendeswar University (Deemed to be University)
Investigators
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Study Director: surinder sachdeva, M.D.S. PROFESSOR
Publications:
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Responsible Party: DR SURINDER SACHDEVA, PROFESSOR, Maharishi Markendeswar University (Deemed to be University)
ClinicalTrials.gov Identifier: NCT04773886    
Other Study ID Numbers: MahrishiMU 1012
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by DR SURINDER SACHDEVA, Maharishi Markendeswar University (Deemed to be University):
pulpal regeneration
pulpitis
pulpotomy
Additional relevant MeSH terms:
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Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases