Clinical and Radiographic Evaluation of Biodentine Versus Formocresol
Condition: Pulp Disease, Dental
MeSH terms: Dental Pulp Diseases; Stomatognathic Diseases
Study type: Interventional

Summary: 
      Aim of the study: To compare Formocresol and Biodentine clinically and radiographically when
      used for pulpotomy of primary molars Study Design : A randomized control clinical trial
      (split mouth and double blind) was conducted on 43 (4-6 years-old) children with decayed
      vital mandibular primary molars which were treated by pulpotomy using both medicaments . All
      treated teeth were followed for one year (at 3, 6, 9 and 12 months clinically and at 6 and 9
      radiographically).
    

Detailed description: 
      Study design Randomized clinical trial, double blinded using split mouth technique. Study
      setting This study was carried out in Pediatric Dentistry Department-Faculty of
      Dentistry-Cairo University- Egypt.

      Patients

      Patients recruited for this study were selected according to the following criteria:

        -  Healthy children between 4 and 6 years of age with two matched bilateral deep carious
           primary mandibular first or second molars.

        -  No evident clinical symptoms of pulpal necrosis or pulp degeneration such as pain on
           percussion, spontaneous pain, history of swelling or presence of sinus tract.

        -  No pathologic or physiologic mobility.

        -  No radiographic evidence of internal and external resorption, pulp stone, and
           interradicular or periapical lesions (Preoperative radiograph).

        -  The remaining tooth structure would be restorable with a stainless steel crown.

        -  Bleeding time after amputation of the coronal pulp tissue was within normal limits (5
           minutes).

      Sample size calculation using sealedenvelop.com, (30) the online sample calculator, sample
      size was calculated assuming the null hypothesis that biodentine and formocresol have an
      average success rate of 95,99 % and 87.8 % respectively (26, 31,32,33). Thus planning a
      binary outcome non inferiority trial with a difference of 8.19 %, then 76 primary molars (38
      per group) are required to be 90% sure that the upper limit of a one-sided 95% confidence
      interval will exclude a difference in favor of the standard group of more than 10% (34).

      With an estimation of 10% annual dropout, sample size was set to 86 primary molars (43 per
      group) (35). Forty three children with the matching criteria of patient selection were
      included in this study.

      Research Ethics Committee approval was obtained from Faculty of Dentistry Cairo University.
      Detailed treatment plan and procedures were explained to the parents and informed written
      consent s were obtained before practical work.

      Randomization Using 4 times folded papers in which one of the tested materials was written
      (43 paper for each material) contained in a closed white envelops (43 envelop in each one
      folded paper of each tested materials were placed), the selected two matched bilateral deep
      carious primary mandibular molars were randomly allocated to one of the tested materials.

      When guardians agreed for their child to participate in the trial, an envelope was drowned
      and patient personal data was written on it. At the time of treatment of the first tooth in
      each patient, one of the folded papers was taken from the envelope and the type of the
      dressing material was recorded. Trial participant and outcome assessors were blinded to the
      type of materials used in each tooth.
    

Intervention name(s): Biodentine; Formocresol
Intervention type(s): Other; Other
Intervention description(s): Biodentine is mainly composed of tricalcium silicate, calcium carbonate and zirconium oxides while the liquid contains calcium chloride as the setting accelerator and water reducing agent; Formocresol is a devitalizing and fixing agent which was introduced to dentistry since 1904 with full concentration of Buckley's formula (19% formaldehyde, 35 % cresol, and 15 % glycerin in distilled water). A five times diluted formula of Buckley's formocresol was used in this study.
Other intervention name(s): Tricresol formalin
Intervention MeSH terms: Formaldehyde
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial, double blinded using split mouth technique.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment