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Is Biodentine, as Successful as, Mineral Trioxide Aggregate

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Biodentine
MTA pulpotomy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Pulpotomy, Primary molars, Biodentine, MTA.

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • No history of spontaneous pain

    • Absence of tenderness to percussion.
    • Absence of physiologic or pathologic tooth mobility.
    • No clinical evidence of pulpal inflammation or degeneration, such as history of swelling or presence of sinus tract.
    • Restorable teeth.
    • Absence of radiographic evidence of internal or external root resorption, pulpal calcification, or osseous disease (periapical or furcation infection).

Exclusion Criteria:

  • Evidence of necrosis after access cavity preparation.
  • Hemostasis could not be achieved within three min after direct contact with a wet cotton pellet, prior to material placement.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Biodentine pulpotomy

    MTA pulpotomy

    Arm Description

    Biodentine (Septodont, France) Pulpotomy for primary molars Clinical and radiographic evaluation Follow up at 1,3,6 and 12 months

    MTA (Angelus- Londrina, Brazil) Pulpotomy for primary molars . it is fine hydrophilic powder consisting of tricalcium silicate, tricalicum aluminate, tricalcium oxide, silicate oxide and bismuth oxide11. It is currently being used in pulpotomy of primary molars with a high rate of success. Clinical and radiographic evaluation. Follow up at 1,3,6 and 12 months

    Outcomes

    Primary Outcome Measures

    radiographic success
    syptom free

    Secondary Outcome Measures

    Full Information

    First Posted
    September 25, 2018
    Last Updated
    September 25, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03686475
    Brief Title
    Is Biodentine, as Successful as, Mineral Trioxide Aggregate
    Official Title
    Is Biodentine, as Successful as, Mineral Trioxide Aggregate for Pulpotomy of Primary Molars? A Split Mouth Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (Actual)
    Primary Completion Date
    July 2017 (Actual)
    Study Completion Date
    September 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
    : A split-mouth controlled clinical trial was carried out on 21 healthy, three to seven years old children, with 42 pairs (84 molars) of contralateral mandibular primary molars indicated for pulpotomy. One paired tooth in one side was designated to Biodentine (Group 1) and the other side for MTA (Group 2) as a pulp medicament. All pulpotomized teeth were finally restored with stainless steel crowns. Subjects were monitored clinically and radiographically at one, three, six and 12 months.
    Detailed Description
    Study design: The present study was a split-mouth controlled clinical trial. Sample size: A sample size of 21 patients with 42 pairs of molars (84 molars) was determined using online sample size calculator (Sealed envelope.com). Subjects: The study population included three to seven years old healthy and cooperative patients who presented at the Pediatric Dental Clinic, Faculty of Dentistry, Cairo University and had two matched bilateral deep carious mandibular primary molars indicated for pulpotomy, that met specific inclusion criteria. Written consent was obtained from the parent/guardian after explaining the full details of the treatment procedure. The criteria for inclusion in this study were: No history of spontaneous pain Absence of tenderness to percussion. Absence of physiologic or pathologic tooth mobility. No clinical evidence of pulpal inflammation or degeneration, such as history of swelling or presence of sinus tract. Restorable teeth. Absence of radiographic evidence of internal or external root resorption, pulpal calcification, or osseous disease (periapical or furcation infection). On the other hand, teeth were excluded if: Evidence of necrosis after access cavity preparation. Hemostasis could not be achieved within three min after direct contact with a wet cotton pellet, prior to material placement. Matched molars in each pair were randomly designated using computer software (Random.org) to Group 1: which received Biodentine (Septodont, France), or Group 2: which received MTA (Angelus- Londrina, Brazil), as pulp medicament. Procedures: Preoperative periapical radiograph using periapical film size two (Speed D Film, Kodak, US) was taken for the molars considered for treatment. Radiographs should be of proper film density and contrast for proper radiographic diagnosis. The pulpotomy procedure was performed by the same operator. Local anesthesia was induced and rubber dam isolation was performed, followed by caries removal and deroofing of the pulp chamber using a #330 high-speed carbide bur mounted in a water-cooled high speed turbine. The coronal pulp tissue was amputated using a sterile sharp spoon excavator. The pulp chamber was irrigated with normal saline. Pulp hemostasis was achieved using a sterile wet cotton pellet applied for two to three min. In Group 1: Biodentine was used according to the manufacturer's instructions. A capsule was gently tapped on a hard surface (to diffuse powder); five drops of liquid from the single dose dispenser were poured into the capsule which was placed in a triturator for 30 sec. The mixture was then introduced into the pulp chamber using amalgam carrier until the entire pulp chamber was completely filled. In Group 2: MTA was used according to the manufacturer's instructions; the powder was mixed with sterile water in a 3:1 powder/water ratio to obtain a thick creamy paste, then placed on the floor of the pulp chamber using a messing gun and compacted against the pulp orifices with a condenser over a moist cotton pellet. Molars of both groups were finally restored with stainless steel crowns (3M, ESPE, Unitek, US) cemented with GI cement. An immediate postoperative radiograph using periapical film size two was taken. Clinical and radiographic evaluation: All treated patients were followed up at one, three, six and 12 months after the pulpotomy for clinical and radiographic evaluation as recommended by the American Academy of Pediatric Dentistry . Independently, two examiners evaluated the teeth clinically and radiographically. The pulpotomized teeth were judged as clinically successful if they met the following criteria: Absence of sensitivity, pain, tenderness to percussion, abscess, fistula or tooth mobility. Radiographic success was defined if there were normal periodontal ligament space, absence of furcation or periapical radiolucency, absence of internal or external root resorption. Widening of the periodontal ligament was not considered failure in absence of other concurrent pathologies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries
    Keywords
    Pulpotomy, Primary molars, Biodentine, MTA.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Masking Description
    blinding
    Allocation
    Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Biodentine pulpotomy
    Arm Type
    Experimental
    Arm Description
    Biodentine (Septodont, France) Pulpotomy for primary molars Clinical and radiographic evaluation Follow up at 1,3,6 and 12 months
    Arm Title
    MTA pulpotomy
    Arm Type
    Active Comparator
    Arm Description
    MTA (Angelus- Londrina, Brazil) Pulpotomy for primary molars . it is fine hydrophilic powder consisting of tricalcium silicate, tricalicum aluminate, tricalcium oxide, silicate oxide and bismuth oxide11. It is currently being used in pulpotomy of primary molars with a high rate of success. Clinical and radiographic evaluation. Follow up at 1,3,6 and 12 months
    Intervention Type
    Other
    Intervention Name(s)
    Biodentine
    Other Intervention Name(s)
    tricalcium silicate cements
    Intervention Description
    pulpotomy for primary molars , clinical and radiographic evaluation at 1,3,6 and 12month
    Intervention Type
    Other
    Intervention Name(s)
    MTA pulpotomy
    Intervention Description
    MTA pulpotomy
    Primary Outcome Measure Information:
    Title
    radiographic success
    Description
    syptom free
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: No history of spontaneous pain Absence of tenderness to percussion. Absence of physiologic or pathologic tooth mobility. No clinical evidence of pulpal inflammation or degeneration, such as history of swelling or presence of sinus tract. Restorable teeth. Absence of radiographic evidence of internal or external root resorption, pulpal calcification, or osseous disease (periapical or furcation infection). Exclusion Criteria: Evidence of necrosis after access cavity preparation. Hemostasis could not be achieved within three min after direct contact with a wet cotton pellet, prior to material placement.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dr Randa Abd El Gawad
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Links:
    URL
    http://scholar.cu.edu.eg
    Description
    cairo university scholar

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