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Biodentine Vital Pulpotomy in Immature Molars

Primary Purpose

Pulp Exposure, Dental

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
pulpotomy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp Exposure, Dental

Eligibility Criteria

6 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Medical history: Healthy children with no physical or mental disorders assured through medical history questioning.
  • Mandibular vital immature first permanent molar with deep caries. Restorable. No clinical evidence of extensive pulp degeneration or periapical pathology.No radiographic evidence of periapical pathosis or interradicular bone loss, internal/external resorption and pulp calcification.

Exclusion Criteria:

  • 1. Patients refuse to cooperate. 2. Spontaneous pain or severe pain which doesn't stop with analgesics. 3. Hemorrhage control wasn't achievable at the operative procedures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    CALCIUM HYDROXIDE™

    Biodentine ™

    Arm Description

    Non-setting Calcium hydroxide Pulpotomy capping agent. Deepak. Promotion Industrial Park, Bari Brahmana, Jammu - 181133 India form : powder and liquid. application : Calcium hydroxide was mixed with saline to a thick consistency immediately before use. The paste was carefully placed on the pulp stump surface 2-3 mm thick over a small sterile wet cotton with a small condenser, and the excess material was scraped off.

    Biodentine ™ Pulpotomy capping agent. Calcium Silicate-Based Material.Septodent®, Saint-Maurdes-Fosses, France form: capsule and liquid. application: According to the instructions of manufacture, Biodentine ™powder and liquid were mixed to achieve a creamy consistency, by mixing a single-unit powder part and 5 drops of a single-unit liquid part for 30 seconds by mixing device . Final mixing and adjustment were done manually to obtain the desired consistency for each case

    Outcomes

    Primary Outcome Measures

    Assessment of pain severity
    ordinal outcome measured with direct questioning to the patient using Verbal Rating Scale ( VRS)
    Absences of swelling / fistulous tract
    binary outcome observed clinically

    Secondary Outcome Measures

    Absence of tenderness to percussion
    binary outcome detected by back of mirror
    Absence of internal or external root resorption
    binary outcome detected in periapical radiograph
    Root maturation
    binary outcome detected in periapical radiograph

    Full Information

    First Posted
    June 24, 2021
    Last Updated
    July 24, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04989036
    Brief Title
    Biodentine Vital Pulpotomy in Immature Molars
    Official Title
    Clinical and Radiographic Evaluation of Apexogenesis Using Calcium Hydroxide Pulpotomy Versus Calcium Silicate-Based Material (Biodentine™) Pulpotomy in Cariously Exposed Vital Immature Permanent First Molars: A Randomized Controlled Trial With 12 Months Follow Up
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2016 (Actual)
    Primary Completion Date
    October 1, 2017 (Actual)
    Study Completion Date
    November 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study aimed to evaluate the clinical and radiographic success of pulpotomy in cariously exposed vital immature first permanent molars using calcium hydroxide and calcium silicate-based material (Biodentine ™). After a 12 months postoperative period, Biodentine ™ proved very useful as a successful pulpotomy agent in young permanent teeth.
    Detailed Description
    Objective: This study aimed to evaluate the clinical and radiographic success of pulpotomy in cariously exposed vital immature first permanent molars using calcium hydroxide and calcium silicate-based material (Biodentine ™). Participants and methods: This study was carried out on patients attending an outpatient clinic in Pediatric Dentistry and Dental Public Health Department - Faculty of Dentistry - Cairo University - Egypt. A total of thirty-five patients had thirty-eight vital immature first permanent molar with deep caries, who satisfied the eligibility criteria and completed the follow-up period. Their age ranged between six years to nine years old with a mean age of 7.5+/-1 years. All teeth were mandibular. In this study, pulpotomy was performed to preserve the vitality and function of the remaining radicular pulp tissue, followed by applying one of the investigated pulp capping materials.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulp Exposure, Dental

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled trial (RCT), parallel group with 1:1 allocation ratio and equivalence framework. Triple blinded (patient, radiographic assessors of results and statistician) Ethics approval by the Human Research Ethics committee at Faculty of Dentistry- Cairo University was taken.
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Masking Description
    Triple blinded (patient, radiographic assessors of results and statistician)
    Allocation
    Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CALCIUM HYDROXIDE™
    Arm Type
    Experimental
    Arm Description
    Non-setting Calcium hydroxide Pulpotomy capping agent. Deepak. Promotion Industrial Park, Bari Brahmana, Jammu - 181133 India form : powder and liquid. application : Calcium hydroxide was mixed with saline to a thick consistency immediately before use. The paste was carefully placed on the pulp stump surface 2-3 mm thick over a small sterile wet cotton with a small condenser, and the excess material was scraped off.
    Arm Title
    Biodentine ™
    Arm Type
    Experimental
    Arm Description
    Biodentine ™ Pulpotomy capping agent. Calcium Silicate-Based Material.Septodent®, Saint-Maurdes-Fosses, France form: capsule and liquid. application: According to the instructions of manufacture, Biodentine ™powder and liquid were mixed to achieve a creamy consistency, by mixing a single-unit powder part and 5 drops of a single-unit liquid part for 30 seconds by mixing device . Final mixing and adjustment were done manually to obtain the desired consistency for each case
    Intervention Type
    Procedure
    Intervention Name(s)
    pulpotomy
    Other Intervention Name(s)
    vital pulp therapy, apexogensis
    Intervention Description
    Pulpotomy refers to the removal of the entire coronal pulp to the level of the root canal orifice(s) or as much as 2-3 mm apical to the orifices. Pulpotomy has indications similar to those of a partial pulpotomy except that the pulp in question is likely to have more extensive inflammation. Since pulpal inflammation is unlikely to extend past the canal orifices, pulpotomy is similar to a partial pulpotomy except that the entire mass of coronal pulp tissue is removed
    Primary Outcome Measure Information:
    Title
    Assessment of pain severity
    Description
    ordinal outcome measured with direct questioning to the patient using Verbal Rating Scale ( VRS)
    Time Frame
    12 months
    Title
    Absences of swelling / fistulous tract
    Description
    binary outcome observed clinically
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Absence of tenderness to percussion
    Description
    binary outcome detected by back of mirror
    Time Frame
    12 months
    Title
    Absence of internal or external root resorption
    Description
    binary outcome detected in periapical radiograph
    Time Frame
    12 months
    Title
    Root maturation
    Description
    binary outcome detected in periapical radiograph
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Medical history: Healthy children with no physical or mental disorders assured through medical history questioning. Mandibular vital immature first permanent molar with deep caries. Restorable. No clinical evidence of extensive pulp degeneration or periapical pathology.No radiographic evidence of periapical pathosis or interradicular bone loss, internal/external resorption and pulp calcification. Exclusion Criteria: 1. Patients refuse to cooperate. 2. Spontaneous pain or severe pain which doesn't stop with analgesics. 3. Hemorrhage control wasn't achievable at the operative procedures

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    after publication , sharing all the data with other researchers
    IPD Sharing Time Frame
    2 year
    IPD Sharing Access Criteria
    after publication

    Learn more about this trial

    Biodentine Vital Pulpotomy in Immature Molars

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