BiodentineTM Versus Formocresol Pulpotomy Technique in Primary Molars
Condition: Dental Caries; Pulpotomy
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this clinical study was to prospectively compare the clinical and
      radiographic success rates of BiodentineTM pulpotomies versus formocresol pulpotomies in
      children vital primary molars.

      A randomized, split-mouth study design was used with a sample of 37 healthy children aged 4-
      to 8-year-old. A total of 56 pairs (112 teeth) of carious primary teeth, 1 pair per child,
      were selected for treatment. One tooth from each pair was randomly assigned to either the
      BiodentineTM pulpotomy group or the formocresol pulpotomy group. Children were followed-up at
      3, 6 and 12 months for clinical evaluation and at 6 and 12 months for radiographic
      evaluation. Data were collected, tabulated and analyzed using Fisher exact and McNemar tests.
      The level of significance was set at P < 0.05.
    

Detailed description: 
      Methods This study was written according to the Consolidated Standards of Reporting Trials
      (CONSORT) statement.

      Study design A double-blinded, split-mouth, randomized, controlled clinical study was done.
      Patients This study was carried out on healthy children aged 4- to 8-year-old. The children
      were selected from the Pediatric Dentistry Clinics, Faculty of Dentistry, King Abdulaziz
      University (KAU), Jeddah. Each patient had at least 2 matched bilateral carious primary
      molars requiring pulpotomy. Each parent signed an informed consent for the child's
      participation in the study. No children were excluded based on gender, race, social or
      economic status.

      Teeth were selected based upon clinical and radiographic criteria. Teeth were unselected if
      any of the inclusion criteria were not met.

      Preoperative periapical radiographs of the molars considered for treatment were taken using
      the XCP extension cone paralleling technique.

      Sample size and power determination Sample size calculation for binary outcome equivalence
      trials was calculated using sample size calculators of a sealed envelope, randomization and
      online databases for clinical trials at
      https://www.sealedenvelope.com/power/binary-equivalence/ Thus, if there is truly no
      difference between the standard and experimental materials, then 102 teeth (51 for each study
      material) are required to be 95% sure that the limits of a two-sided 90% confidence interval
      will exclude a difference between the standard and experimental group of more than 10%. It is
      usually prudent to plan to include more than the minimum number of teeth in a study to
      compensate for loss during follow-up or other causes of attrition. The percentage of teeth
      that could be lost to follow up at all stages was set at 10% thereby forcing an increase of 5
      pairs to the calculated sample size. Thus, the final sample size for this study was
      calculated to be 112 teeth.

      Randomization Since the teeth indicated for pulpotomy must be treated as soon as possible,
      the patients were included at the time of diagnosis (identification) and randomization for
      the materials on the sides was done. In order to overcome the variable of the side preferred
      by the operator, the investigators made sure that both materials equally treated each side.
      This was performed by carrying out the block randomization technique with closed envelopes.
      Before recruitment of the patients, 56 sealed envelopes containing the result of
      randomization were prepared, sealed, and blindly mixed in a box. An envelope was for each
      block of two contralateral teeth (one pair). After that, the envelopes were numerated blindly
      from 1 to 56. The envelopes were assigned to the 56 pairs according to the beginning of the
      treatment (envelop number 1 was assigned to the earliest pair ready for treatment and so on).
      Each envelope was unsealed after the signature of the informed consent and immediately before
      the implementation of the first procedure on the right tooth.

      One hundred and twelve molars were randomly divided into two treatment groups. Group I
      comprised 56 molars treated with BiodentineTM (experimental). Group II comprised 56 molars
      treated with formocresol (control). Each patient received 2 treatments, BiodentineTM on one
      side of the oral cavity and formocresol on the other side.

      Procedures An operator performed the pulpotomy procedures. After application of topical
      anesthesia (Beutlich LP Pharmaceuticals, USA), local anesthesia was administrated using
      27-gauge short needles and syringes loaded with carpules, each one contained 1.8 ml of
      Lidocaine 2% with epinephrine concentration of 1:100000 (Octocaine® 100, Novocol Healthcare
      Inc. Cambridge, Ontario, Canada). Complete isolation was performed using a rubber dam and
      saliva ejector. Removal of caries and deroofing of the pulp chamber were performed using a
      no. 330 high-speed carbide bur with copious water spray. A sharp sterile spoon excavator or a
      slow-speed round carbide bur (no. 6 or no. 8) was used for coronal pulp amputation. Then the
      pulp chamber was washed with normal saline and bleeding was controlled by placing a cotton
      pellet moistened with water in the pulp chamber for 5 minutes.

      In the experimental group (group I), BiodentineTM (Septodont Ltd., Saint Maur des Faussés,
      France) was used following the manufacturer's recommendations. The whole pulp chamber was
      entirely filled with BiodentineTM until the occlusal surface. In control (group II), a
      sterile cotton pellet moistened with 1:5 concentration formocresol (Buckley's Formocresol,
      Sultan Healthcare, Englewood, NJ, USA) then blotted to remove excess was placed for 5 minutes
      on the pulp stumps and then the pulps were covered with zinc oxide-eugenol (IRM; Dentsply,
      Milford, DE) dressing. In both groups, all teeth were finally restored using a stainless
      steel crown (SSC) (3M/ESPE, St. Paul, Minn., USA).

      Follow-up was done for all children clinically at 3, 6 and 12 months and radiographically at
      6 and 12 months. Two full-time pediatric dentistry faculty members (other than the operator)
      from KAU blindly evaluated all the teeth clinically and radiographically.

      Outcome assessment criteria The pulpotomy procedure was decided a clinical success if the
      tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to
      percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility. The pulpotomized
      tooth was judged to be radiographically successful if it demonstrated the following criteria:
      (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No
      internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not
      considered as a treatment failure.

      Statistical analysis Data were statistically analyzed using the Statistical Package for
      Social Sciences (SPSS) version 20.0 (SPSS Inc., Chicago, IL). Inter- and intra-examiner
      agreement was performed using the Kappa statistic. Fisher exact test was used to assess
      differences in success rates between both groups at 3, 6 or 12 months. McNemar's test was
      used to compare these rates in each group between pairs of follow up periods. The level of
      significance was set at P < 0.05.

      Ethical Considerations Ethical approval was obtained from the Research Ethics Committee,
      Faculty of Dentistry, KAU, Jeddah, Kingdom of Saudi Arabia (Approval no. 029-14).
    

Intervention name(s): BiodentineTM; Formocresol
Intervention type(s): Other; Drug
Intervention description(s): In the experimental group, BiodentineTM was used following the manufacturer's recommendations. The whole pulp chamber was entirely filled with BiodentineTM until the occlusal surface. Follow-up was done for all children clinically at 3, 6 and 12 months and radiographically at 6 and 12 months.; In control group, a sterile cotton pellet moistened with 1:5 concentration formocresol then blotted to remove excess was placed for 5 minutes on the pulp stumps and then the pulps were covered with zinc oxide-eugenol (IRM; Dentsply, Milford, DE) dressing. Follow-up was done for all children clinically at 3, 6 and 12 months and radiographically at 6 and 12 months.
Other intervention name(s): Bioactive dentine substitute; Buckley's Formocresol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A double-blinded, split-mouth, randomized, controlled clinical study design was used with a sample of 37 healthy children aged 4- to 8-year-old. A total of 56 pairs (112 teeth) of carious primary teeth, 1 pair per child, were selected for treatment. One tooth from each pair was randomly assigned to either the BiodentineTM pulpotomy group or the formocresol pulpotomy group.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: BiodentineTM; Formocresol; Primary molars; Pulpotomy