<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03779698</url>
  </required_header>
  <id_info>
    <org_study_id>FacultyofDentistry</org_study_id>
    <nct_id>NCT03779698</nct_id>
  </id_info>
  <brief_title>BiodentineTM Versus Formocresol Pulpotomy Technique in Primary Molars</brief_title>
  <official_title>BiodentineTM Versus Formocresol Pulpotomy Technique in Primary Molars: A 12-Month Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Abdulaziz University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Abdulaziz University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this clinical study was to prospectively compare the clinical and&#xD;
      radiographic success rates of BiodentineTM pulpotomies versus formocresol pulpotomies in&#xD;
      children vital primary molars.&#xD;
&#xD;
      A randomized, split-mouth study design was used with a sample of 37 healthy children aged 4-&#xD;
      to 8-year-old. A total of 56 pairs (112 teeth) of carious primary teeth, 1 pair per child,&#xD;
      were selected for treatment. One tooth from each pair was randomly assigned to either the&#xD;
      BiodentineTM pulpotomy group or the formocresol pulpotomy group. Children were followed-up at&#xD;
      3, 6 and 12 months for clinical evaluation and at 6 and 12 months for radiographic&#xD;
      evaluation. Data were collected, tabulated and analyzed using Fisher exact and McNemar tests.&#xD;
      The level of significance was set at P &lt; 0.05.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods This study was written according to the Consolidated Standards of Reporting Trials&#xD;
      (CONSORT) statement.&#xD;
&#xD;
      Study design A double-blinded, split-mouth, randomized, controlled clinical study was done.&#xD;
      Patients This study was carried out on healthy children aged 4- to 8-year-old. The children&#xD;
      were selected from the Pediatric Dentistry Clinics, Faculty of Dentistry, King Abdulaziz&#xD;
      University (KAU), Jeddah. Each patient had at least 2 matched bilateral carious primary&#xD;
      molars requiring pulpotomy. Each parent signed an informed consent for the child's&#xD;
      participation in the study. No children were excluded based on gender, race, social or&#xD;
      economic status.&#xD;
&#xD;
      Teeth were selected based upon clinical and radiographic criteria. Teeth were unselected if&#xD;
      any of the inclusion criteria were not met.&#xD;
&#xD;
      Preoperative periapical radiographs of the molars considered for treatment were taken using&#xD;
      the XCP extension cone paralleling technique.&#xD;
&#xD;
      Sample size and power determination Sample size calculation for binary outcome equivalence&#xD;
      trials was calculated using sample size calculators of a sealed envelope, randomization and&#xD;
      online databases for clinical trials at&#xD;
      https://www.sealedenvelope.com/power/binary-equivalence/ Thus, if there is truly no&#xD;
      difference between the standard and experimental materials, then 102 teeth (51 for each study&#xD;
      material) are required to be 95% sure that the limits of a two-sided 90% confidence interval&#xD;
      will exclude a difference between the standard and experimental group of more than 10%. It is&#xD;
      usually prudent to plan to include more than the minimum number of teeth in a study to&#xD;
      compensate for loss during follow-up or other causes of attrition. The percentage of teeth&#xD;
      that could be lost to follow up at all stages was set at 10% thereby forcing an increase of 5&#xD;
      pairs to the calculated sample size. Thus, the final sample size for this study was&#xD;
      calculated to be 112 teeth.&#xD;
&#xD;
      Randomization Since the teeth indicated for pulpotomy must be treated as soon as possible,&#xD;
      the patients were included at the time of diagnosis (identification) and randomization for&#xD;
      the materials on the sides was done. In order to overcome the variable of the side preferred&#xD;
      by the operator, the investigators made sure that both materials equally treated each side.&#xD;
      This was performed by carrying out the block randomization technique with closed envelopes.&#xD;
      Before recruitment of the patients, 56 sealed envelopes containing the result of&#xD;
      randomization were prepared, sealed, and blindly mixed in a box. An envelope was for each&#xD;
      block of two contralateral teeth (one pair). After that, the envelopes were numerated blindly&#xD;
      from 1 to 56. The envelopes were assigned to the 56 pairs according to the beginning of the&#xD;
      treatment (envelop number 1 was assigned to the earliest pair ready for treatment and so on).&#xD;
      Each envelope was unsealed after the signature of the informed consent and immediately before&#xD;
      the implementation of the first procedure on the right tooth.&#xD;
&#xD;
      One hundred and twelve molars were randomly divided into two treatment groups. Group I&#xD;
      comprised 56 molars treated with BiodentineTM (experimental). Group II comprised 56 molars&#xD;
      treated with formocresol (control). Each patient received 2 treatments, BiodentineTM on one&#xD;
      side of the oral cavity and formocresol on the other side.&#xD;
&#xD;
      Procedures An operator performed the pulpotomy procedures. After application of topical&#xD;
      anesthesia (Beutlich LP Pharmaceuticals, USA), local anesthesia was administrated using&#xD;
      27-gauge short needles and syringes loaded with carpules, each one contained 1.8 ml of&#xD;
      Lidocaine 2% with epinephrine concentration of 1:100000 (Octocaine® 100, Novocol Healthcare&#xD;
      Inc. Cambridge, Ontario, Canada). Complete isolation was performed using a rubber dam and&#xD;
      saliva ejector. Removal of caries and deroofing of the pulp chamber were performed using a&#xD;
      no. 330 high-speed carbide bur with copious water spray. A sharp sterile spoon excavator or a&#xD;
      slow-speed round carbide bur (no. 6 or no. 8) was used for coronal pulp amputation. Then the&#xD;
      pulp chamber was washed with normal saline and bleeding was controlled by placing a cotton&#xD;
      pellet moistened with water in the pulp chamber for 5 minutes.&#xD;
&#xD;
      In the experimental group (group I), BiodentineTM (Septodont Ltd., Saint Maur des Faussés,&#xD;
      France) was used following the manufacturer's recommendations. The whole pulp chamber was&#xD;
      entirely filled with BiodentineTM until the occlusal surface. In control (group II), a&#xD;
      sterile cotton pellet moistened with 1:5 concentration formocresol (Buckley's Formocresol,&#xD;
      Sultan Healthcare, Englewood, NJ, USA) then blotted to remove excess was placed for 5 minutes&#xD;
      on the pulp stumps and then the pulps were covered with zinc oxide-eugenol (IRM; Dentsply,&#xD;
      Milford, DE) dressing. In both groups, all teeth were finally restored using a stainless&#xD;
      steel crown (SSC) (3M/ESPE, St. Paul, Minn., USA).&#xD;
&#xD;
      Follow-up was done for all children clinically at 3, 6 and 12 months and radiographically at&#xD;
      6 and 12 months. Two full-time pediatric dentistry faculty members (other than the operator)&#xD;
      from KAU blindly evaluated all the teeth clinically and radiographically.&#xD;
&#xD;
      Outcome assessment criteria The pulpotomy procedure was decided a clinical success if the&#xD;
      tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to&#xD;
      percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility. The pulpotomized&#xD;
      tooth was judged to be radiographically successful if it demonstrated the following criteria:&#xD;
      (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No&#xD;
      internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not&#xD;
      considered as a treatment failure.&#xD;
&#xD;
      Statistical analysis Data were statistically analyzed using the Statistical Package for&#xD;
      Social Sciences (SPSS) version 20.0 (SPSS Inc., Chicago, IL). Inter- and intra-examiner&#xD;
      agreement was performed using the Kappa statistic. Fisher exact test was used to assess&#xD;
      differences in success rates between both groups at 3, 6 or 12 months. McNemar's test was&#xD;
      used to compare these rates in each group between pairs of follow up periods. The level of&#xD;
      significance was set at P &lt; 0.05.&#xD;
&#xD;
      Ethical Considerations Ethical approval was obtained from the Research Ethics Committee,&#xD;
      Faculty of Dentistry, KAU, Jeddah, Kingdom of Saudi Arabia (Approval no. 029-14).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Two full-time pediatric dentistry faculty members (other than the operator) from KAU blindly evaluated all the teeth clinically and radiographically.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical evaluation of BiodentineTM and formocresol pulpotomies 3 months after treatment</measure>
    <time_frame>After 3 months</time_frame>
    <description>Clinical evaluation of BiodentineTM and formocresol pulpotomies was performed 3 months after treatment using the preset clinical 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical evaluation of BiodentineTM and formocresol pulpotomies 6 months after treatment</measure>
    <time_frame>After 6 months</time_frame>
    <description>Clinical evaluation of BiodentineTM and formocresol pulpotomies was performed 6 months after treatment using the preset clinical 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical evaluation of BiodentineTM and formocresol pulpotomies 12 months after treatment</measure>
    <time_frame>After12 months</time_frame>
    <description>Clinical evaluation of BiodentineTM and formocresol pulpotomies was performed 12 months after treatment using the preset clinical 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiographic evaluation of BiodentineTM and formocresol pulpotomies 6 months after treatment</measure>
    <time_frame>After 6 months</time_frame>
    <description>Radiographic evaluation of BiodentineTM and formocresol pulpotomies was performed 6 months after treatment using periapical radiographs. 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiographic evaluation of BiodentineTM and formocresol pulpotomies 12 months after treatment</measure>
    <time_frame>After 12 months</time_frame>
    <description>Radiographic evaluation of BiodentineTM and formocresol pulpotomies was performed 12 months after treatment using periapical radiographs. 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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Dental Caries</condition>
  <condition>Pulpotomy</condition>
  <arm_group>
    <arm_group_label>BiodentineTM pulpotomy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A Bioactive Dentine Substitute (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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Formocresol pulpotomy group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>BiodentineTM</intervention_name>
    <description>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.</description>
    <arm_group_label>BiodentineTM pulpotomy group</arm_group_label>
    <arm_group_label>Formocresol pulpotomy group</arm_group_label>
    <other_name>Bioactive dentine substitute</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Formocresol</intervention_name>
    <description>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.</description>
    <arm_group_label>BiodentineTM pulpotomy group</arm_group_label>
    <arm_group_label>Formocresol pulpotomy group</arm_group_label>
    <other_name>Buckley's Formocresol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patient inclusion criteria:&#xD;
&#xD;
          -  Patients with at least two matched bilateral deep carious primary molars indicated for&#xD;
             pulpotomy.&#xD;
&#xD;
          -  Patients within the age group of four to eight years.&#xD;
&#xD;
          -  Healthy patients (both physically and mentally) without any known medical history of&#xD;
             systemic conditions contraindicating pulp treatment.&#xD;
&#xD;
          -  Cooperative patients who had behavioral ratings &quot;positive&quot; or &quot;definitely positive&quot;&#xD;
             according to the Frankl behavior classification scale.&#xD;
&#xD;
          -  Written consent was obtained from the parent/guardian after explaining the full&#xD;
             details of the treatment procedure and its possible outcomes, discomforts, risks, and&#xD;
             benefits.&#xD;
&#xD;
          -  No patients were excluded on the basis of gender, race, social or economic background.&#xD;
&#xD;
        Patients not satisfying any of the above-mentioned criteria were excluded from the study.&#xD;
&#xD;
        Teeth inclusion criteria:&#xD;
&#xD;
        Teeth were selected based upon the following clinical and radiographic criteria:&#xD;
        Clinically, the study included teeth with restorable crowns, teeth with pathologic carious&#xD;
        or mechanical exposure of vital pulps and teeth with no clinical symptoms or evidence of&#xD;
        pulp degeneration, such as spontaneous or nocturnal pain, pain on percussion, history of&#xD;
        swelling, or sinus tracts and teeth with no tenderness to percussion, physiologic or&#xD;
        pathologic mobility. Radiographically, the recruited teeth should have a normal&#xD;
        radiographic appearance with healthy supporting tissues, no signs of internal resorption,&#xD;
        or pathologic external root resorption and no periapical or inter-radicular pathosis, with&#xD;
        at least two-thirds of the root remaining (not more than one-third of the root is&#xD;
        physiologically resorbed).&#xD;
&#xD;
        Teeth exclusion criteria:&#xD;
&#xD;
        Teeth were excluded if (1) any of the above-mentioned clinical or radiographic inclusion&#xD;
        criteria were not satisfied, (2) hemostasis could not be achieved within 5 minutes by&#xD;
        direct contact with a wet cotton pellet, prior to material placement, or (3) the remaining&#xD;
        radicular tissue was non-vital (with suppuration or purulence necrosis).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Najlaa M Alamoudi, BDS,MSc,DSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>King Abdulaziz University, Faculty of Dentistry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>King Abdulaziz University, Faculty of Dentistry</name>
      <address>
        <city>Jeddah</city>
        <state>Makkah</state>
        <zip>21589</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <reference>
    <citation>Erdem AP, Guven Y, Balli B, Ilhan B, Sepet E, Ulukapi I, Aktoren O. Success rates of mineral trioxide aggregate, ferric sulfate, and formocresol pulpotomies: a 24-month study. Pediatr Dent. 2011 Mar-Apr;33(2):165-70.</citation>
    <PMID>21703067</PMID>
  </reference>
  <reference>
    <citation>Agamy HA, Bakry NS, Mounir MM, Avery DR. Comparison of mineral trioxide aggregate and formocresol as pulp-capping agents in pulpotomized primary teeth. Pediatr Dent. 2004 Jul-Aug;26(4):302-9.</citation>
    <PMID>15344622</PMID>
  </reference>
  <reference>
    <citation>Farsi N, Alamoudi N, Balto K, Mushayt A. Success of mineral trioxide aggregate in pulpotomized primary molars. J Clin Pediatr Dent. 2005 Summer;29(4):307-11. doi: 10.17796/jcpd.29.4.n80t77w625118k73.</citation>
    <PMID>16161395</PMID>
  </reference>
  <reference>
    <citation>Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-7. doi: 10.1016/j.ijsu.2011.09.004. Epub 2011 Oct 13. No abstract available.</citation>
    <PMID>22019563</PMID>
  </reference>
  <reference>
    <citation>Sonmez D, Sari S, Cetinbas T. A Comparison of four pulpotomy techniques in primary molars: a long-term follow-up. J Endod. 2008 Aug;34(8):950-5. doi: 10.1016/j.joen.2008.05.009.</citation>
    <PMID>18634926</PMID>
  </reference>
  <reference>
    <citation>Fuks AB, Bimstein E, Guelmann M, Klein H. Assessment of a 2 percent buffered glutaraldehyde solution in pulpotomized primary teeth of schoolchildren. ASDC J Dent Child. 1990 Sep-Oct;57(5):371-5.</citation>
    <PMID>2120303</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Abdulaziz University</investigator_affiliation>
    <investigator_full_name>Najlaa Alamoudi</investigator_full_name>
    <investigator_title>Professor in Pediatric Dentistry Department, Medical Director, KAU-DH Program Director, Post Grad Studies for Master and PhD programs Program Director,of Saudi Commission for Health Specialities, Faculty of Dentistry- King Abdulaziz University</investigator_title>
  </responsible_party>
  <keyword>BiodentineTM</keyword>
  <keyword>Formocresol</keyword>
  <keyword>Primary molars</keyword>
  <keyword>Pulpotomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03779698
org study id: FacultyofDentistry
nct id: NCT03779698
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
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.
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).
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.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Two full-time pediatric dentistry faculty members (other than the operator) from KAU blindly evaluated all the teeth clinically and radiographically.
measure: Clinical evaluation of BiodentineTM and formocresol pulpotomies 3 months after treatment
time frame: After 3 months
description: Clinical evaluation of BiodentineTM and formocresol pulpotomies was performed 3 months after treatment using the preset clinical 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.
measure: Clinical evaluation of BiodentineTM and formocresol pulpotomies 6 months after treatment
time frame: After 6 months
description: Clinical evaluation of BiodentineTM and formocresol pulpotomies was performed 6 months after treatment using the preset clinical 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.
measure: Clinical evaluation of BiodentineTM and formocresol pulpotomies 12 months after treatment
time frame: After12 months
description: Clinical evaluation of BiodentineTM and formocresol pulpotomies was performed 12 months after treatment using the preset clinical 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.
measure: Radiographic evaluation of BiodentineTM and formocresol pulpotomies 6 months after treatment
time frame: After 6 months
description: Radiographic evaluation of BiodentineTM and formocresol pulpotomies was performed 6 months after treatment using periapical radiographs. 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.
measure: Radiographic evaluation of BiodentineTM and formocresol pulpotomies 12 months after treatment
time frame: After 12 months
description: Radiographic evaluation of BiodentineTM and formocresol pulpotomies was performed 12 months after treatment using periapical radiographs. 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.
arm group label: BiodentineTM pulpotomy group
arm group type: Experimental
description: A Bioactive Dentine Substitute (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.
arm group label: Formocresol pulpotomy group
arm group type: Active Comparator
description: 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.
intervention type: Other
intervention name: BiodentineTM
description: 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.
arm group label: BiodentineTM pulpotomy group
arm group label: Formocresol pulpotomy group
other name: Bioactive dentine substitute
intervention type: Drug
intervention name: Formocresol
description: 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.
arm group label: BiodentineTM pulpotomy group
arm group label: Formocresol pulpotomy group
other name: Buckley's Formocresol
criteria: 
gender: All
minimum age: 4 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Najlaa M Alamoudi, BDS,MSc,DSc
role: Principal Investigator
affiliation: King Abdulaziz University, Faculty of Dentistry
facility: 
country: Saudi Arabia
citation: Erdem AP, Guven Y, Balli B, Ilhan B, Sepet E, Ulukapi I, Aktoren O. Success rates of mineral trioxide aggregate, ferric sulfate, and formocresol pulpotomies: a 24-month study. Pediatr Dent. 2011 Mar-Apr;33(2):165-70.
PMID: 21703067
citation: Agamy HA, Bakry NS, Mounir MM, Avery DR. Comparison of mineral trioxide aggregate and formocresol as pulp-capping agents in pulpotomized primary teeth. Pediatr Dent. 2004 Jul-Aug;26(4):302-9.
PMID: 15344622
citation: Farsi N, Alamoudi N, Balto K, Mushayt A. Success of mineral trioxide aggregate in pulpotomized primary molars. J Clin Pediatr Dent. 2005 Summer;29(4):307-11. doi: 10.17796/jcpd.29.4.n80t77w625118k73.
PMID: 16161395
citation: Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-7. doi: 10.1016/j.ijsu.2011.09.004. Epub 2011 Oct 13. No abstract available.
PMID: 22019563
citation: Sonmez D, Sari S, Cetinbas T. A Comparison of four pulpotomy techniques in primary molars: a long-term follow-up. J Endod. 2008 Aug;34(8):950-5. doi: 10.1016/j.joen.2008.05.009.
PMID: 18634926
citation: Fuks AB, Bimstein E, Guelmann M, Klein H. Assessment of a 2 percent buffered glutaraldehyde solution in pulpotomized primary teeth of schoolchildren. ASDC J Dent Child. 1990 Sep-Oct;57(5):371-5.
PMID: 2120303
responsible party type: Principal Investigator
investigator affiliation: King Abdulaziz University
investigator full name: Najlaa Alamoudi
investigator title: Professor in Pediatric Dentistry Department, Medical Director, KAU-DH Program Director, Post Grad Studies for Master and PhD programs Program Director,of Saudi Commission for Health Specialities, Faculty of Dentistry- King Abdulaziz University
mesh term: Dental Caries
sharing ipd: Undecided