Is Biodentine, as Successful as, Mineral Trioxide Aggregate
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

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.
    

Intervention name(s): Biodentine; MTA pulpotomy
Intervention type(s): Other; Other
Intervention description(s): pulpotomy for primary molars , clinical and radiographic evaluation at 1,3,6 and 12month; MTA pulpotomy
Other intervention name(s): tricalcium silicate cements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulpotomy, Primary molars, Biodentine, MTA.