Bioactive Materials in Pulp Therapy of Primary Teeth
Condition: Pulpitis; Pulp Disease, Dental
MeSH terms: Pulpitis; Dental Pulp Diseases; Stomatognathic Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the clinical and radiographic success of a new
      injectable, fast setting bioceramic root repair material (BC RRM) putty with mineral trioxide
      aggregate (MTA) in pulpotomy procedures of primary teeth. The null hypothesis (H0) is that
      there is no difference in the clinical and radiographic success between the TotalFill® BC
      RRM™ Fast Set Putty and Produits Dentaires™ (PD™) MTA WHITE when used as a pulp dressing in
      pulpotomies of primary molars.
    

Detailed description: 
      Dental Caries is the most common chronic disease worldwide and the most common disease of
      childhood, with increasing prevalence in many countries, including Egypt. About 70% of
      Egyptian children have some untreated caries experience. This percentage was also reported by
      an unpublished nationwide survey funded by the World Health Organization (WHO).

      Dental decay is the primary cause for oral pain and tooth loss. Toothache as a result of
      untreated caries is persistent and often severe. In children, the prevalence of dental pain
      ranges from 5% to 33% and increases with caries severity, child age and decreasing economic
      status. Untreated caries in children can lead to pain, sepsis and affect the quality of life
      of children and their families, such as lost school days, family disruption, and the need for
      costly dental treatment.

      Tooth decay has a multifactorial nature of occurrence. The carious process is a result of an
      imbalance between pathogenic factors, namely the high frequency of fermentable sugar intake
      and the increase in acid-producing bacteria, which outweigh host protective factors in the
      oral cavity favoring demineralization of the tooth structure. This on-going process
      progresses more rapidly in primary compared to permanent teeth which may be attributed to the
      different anatomical characteristics between them. Thinner enamel and dentin as well as
      larger pulp and higher pulp horns make deciduous teeth more vulnerable to degradation of hard
      tissues and pulpal affection. Approximately 75% of deep carious lesions were found clinically
      with pulp exposure.

      The deciduous teeth are important for mastication, speech, esthetics as well as for the
      preservation of arch integrity and space for the permanent successors. Hence, pulp therapy is
      the appropriate alternative to extraction for pulpally affected primary teeth in most
      clinical situations. Depending on the extension of the carious process, different pulp
      treatment modalities are available, pulpotomy being the most common among them with a high
      success rate of 82.6%. Complete pulpotomy involves the complete removal of the inflamed
      and/or infected coronal pulp tissue and the application of a medicament to the pulp chamber
      or radicular pulp remnants allowing healing of the radicular pulp tissue.

      For decades, formocresol had been the gold standard material for pulpotomy procedures in
      primary teeth until mineral trioxide aggregate (MTA) was introduced. According to several
      systematic reviews and meta-analysis, MTA presents superior performance and higher success
      rates compared to other materials in pulpotomy of primary teeth. MTA pulpotomy has become a
      safe and biocompatible treatment alternative with success rates comparable to formocresol
      pulpotomy.

      Although MTA has been recently considered the gold standard material for pulpotomy
      procedures, some drawbacks such as poor handling and long setting time are challenging when
      used as pulpotomy dressing in primary teeth of children. Thus, the evaluation of the clinical
      and radiographic performance of other materials such as a bioceramic root repair material in
      a convenient injectable form with faster setting time is of paramount importance for the
      management of dental caries in the pediatric patient.

      Evidence is lacking as to the effectiveness of bioceramic materials as pulp dressing in the
      primary dentition and to their clinical or radiographic success compared to other materials.
      Different bioceramic root repair materials (BC RRM) have been used in the adult population.
      To our knowledge, there are no studies evaluating the use of BC RRM in pulp therapy of
      deciduous molars. Since MTA has been recently advocated to be the gold standard in pulp
      therapy, it is chosen as the comparator in the control group.

      A two arm, parallel group, randomized controlled trial, with 1:1 allocation ratio to either
      study group or control group, is the study of choice to test the null hypothesis and answer
      the research question.

      The study will be conducted at the outpatient clinic of the department of Pediatric Dentistry
      and Dental Public Health, Faculty of Dentistry, Ain Shams University. This research will be
      reviewed by the Research Ethics Committee and Institutional Review Board, Faculty of
      Dentistry, Ain Shams University. A verbal as well as a written consent will be obtained from
      the caregivers of the participants after explaining the objectives of the study and assuring
      complete confidentiality of data. All caregivers and participants will be informed that they
      have the right to withdraw from the study at any time. Moreover, participants 6 years and
      older will be requested to sign an assent form after an age appropriate explanation of the
      trial procedures and their objectives. All consent and assent forms are translated into
      Arabic.

      A power analysis was designed to have adequate power to apply a statistical test of the
      research hypothesis (null hypothesis) that there was no difference between the clinical and
      radiographic success between the bioceramic root repair material and Mineral Trioxide
      Aggregate when used as a pulp dressing in pulpotomies of primary molars. By adopting an alpha
      (α) level of 0.05 (5%), a beta (β) level of 0.20 (20%) i.e. power=80%, and using an effect
      size (w=0.430); the predicted sample size (n) was found to be a total of (52) teeth; i.e.
      (26) for each group and (13) for each subgroup. Sample size calculation was performed using
      G*Power version 3.1.9.2.44 The sample size was increased by 15% to (30) primary molars per
      group, i.e. (15) molars per subgroup and (60) in total to compensate for drop-outs.

      The study interventions are expected to be conducted from 2020 until 2022. After informed
      consent, baseline clinical and radiographic assessment will be obtained and recorded in the
      patient's examination sheet. Enrolled participant's tooth will be then randomly allocated to
      the experiment or control intervention group. Participant will be recalled for follow up
      assessments at 1, 3, 6 and 12 months. A 14 day window, defined as 7 days before and 7 days
      after the due date, will be available to complete the 1 and 3 month follow-up evaluations and
      a 28 day window, defined as 7 days before and 21 days after the due date, will be available
      to complete the 6 and 12 month follow up evaluations.

      Participants' data will be recorded in an examination sheet and stored as hard copy files.
      Patients' information will be regarded as confidential and will never be revealed at all
      times. This will be ensured by assigning codes to participants' teeth undergoing
      intervention.

      Several attempts will be made calling participants on the phone for clinical and radiographic
      follow up appointments at 1, 3, 6 and 12 months. Patients who fail to show up at the follow
      up examinations, within the defined follow up windows, will be automatically excluded from
      the study. Patients who are no longer willing to continue in the study have the right to quit
      at any time and will be offered to continue dental treatment at the department's outpatient
      clinic.

      All data will be collected, tabulated, summarized and statistically analyzed using the
      Statistical Packages for Social Sciences (SPSS) software.

      Regular unannounced audits by the Research Ethics Committee, Faculty of Dentistry, Ain Shams
      University are expected as to ascertain that protocol guidelines are followed throughout the
      study. In addition to the study supervisors, independent staff members and clinic supervisors
      of the Department of Pediatric Dentistry and Dental Public Health, Ain Shams University
      monitor clinical performance to ensure adherence to best practice.

      MTA and BC RRM have been shown to have no adverse effects on healthy patients. On the
      contrary, they have been shown to be biomimetic and biocompatible when used for endodontic
      procedures in adults. Failure of pulp therapy and abscess formation might occur as with all
      materials used in pulpotomies to this date. Short term follow up will avoid the occurrence of
      any serious condition and will allow its instant treatment. Any adverse event will be
      recorded and managed promptly. Furthermore, in case of consistent failures, the use of the
      experimental material will be stopped and patients will be treated with another modality.
    

Intervention name(s): Bioceramic root repair material as pulp dressing in pulpotomy in primary molars; Mineral Trioxide Aggregate as pulp dressing in primary molars (MTA)
Intervention type(s): Combination Product; Combination Product
Intervention description(s): BC RRM-F, a novel premixed bioceramic-based putty, can be used as a pulp dressing to promote pulp healing and repair with an added convenience for the pediatric patient. The aim of the present study is to evaluate the efficacy of a bioceramic root repair material as pulp dressing in pulpotomy in primary molars. The success of this material as pulpotomy dressing in primary molars will be evaluated clinically and radiographically in comparison to mineral trioxide aggregate pulpotomy. Both materials will be compared in terms of ease of handling, time to perform procedure and convenience of application. Each material's success will be evaluated by comparing its performance with or without the added peripheral seal of a stainless steel crown.; MTA's sealing ability, biocompatibility, ability to stimulate hard tissue formation and its regenerative ability when used in contact with pulp tissues has made MTA pulpotomy the new gold standard as opposed to formocresol pulpotomy in treating the amputated pulp stumps of primary molars.
Other intervention name(s): Bioceramic Root Repair Material Fast Set Putty (BC RRM-F); TotalFill® BC RRM™ Fast Set Putty, FKG Dentaire SA, Switzerland; PD™ MTA WHITE, Produits Dentaires SA, Switzerland
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After informed consent, baseline clinical and radiographic assessment will be obtained and recorded in the patient's examination sheet. Enrolled participant's tooth will be then randomly allocated to the experiment or control intervention group. Participant will be recalled for follow up assessments at 1, 3, 6 and 12 months. A 14 day window, defined as 7 days before and 7 days after the due date, will be available to complete the 1 and 3 month follow-up evaluations and a 28 day window, defined as 7 days before and 21 days after the due date, will be available to complete the 6 and 12 month follow up evaluations.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulpitis; Pulp Inflammation; Primary dentition; bioceramic; root repair material; deciduous dentition; pulpotomy; MTA; bioactive