Partial Versus Complete Pulpotomy Using Three Different Materials in Primary Molars: a Clinical Study
Condition: Decayed Primary Molars
Study type: Interventional
Phase: Phase 4

Summary: 
      The purposes of the study to compare partial pulpotomy versus complete pulpotomy in primary
      molars using three different materials (Formocresol, MTA, Theracal LC) . After 6, 9, 12 and
      15 months follow up each case will be evaluated radiographically and clinically. the
      radiographic criteria to be evaluated are (radiolucency, resorption, widening in periodontal
      ligament space, Crypt involvement) and clinical criteria are ( pain, tenderness, fistula,
      abnormal mobility) upon these criteria some recommendations will be made on success and
      failure rate of each material and each technique.
    

Detailed description: 
      In children, deep carious lesions represent the most common disease of primary teeth; 42% of
      children aged 2 to 11 have dental carious lesions in their primary teeth, with an average of
      1.6 decayed teeth per child. The most important objective of pediatric dentistry treatment is
      the preservation of functional primary teeth until natural exfoliation. In the era of
      conservative dentistry we are now focusing on repair rather than replacement.

      Challenges regarding the best treatment modality in primary molars with deep carious lesions
      that are free of signs or symptoms have continued over the years. Based on a recent
      systematic review and a new American Academy of Pediatric Dentistry (AAPD) Guideline for
      vital pulp therapy in primary teeth, indirect pulp therapy (IPT), direct pulp cap (DPC), and
      pulpotomy are all viable options for treating the pulp in primary teeth with deep carious
      lesions.

      Partial pulpotomy (PP) was originally a means of preserving the remaining coronal and
      radicular pulp tissues in permanent teeth after a traumatic pulp exposure. In 1982, Cvek
      introduced this technique for permanent traumatized teeth with complicated crown fracture,
      which involved removing two mm of pulp and then dressing the non-inflamed pulp with calcium
      hydroxide. However, according to the new AAPD best practices recommendation, PP is also
      indicated in young permanent teeth with a carious pulp exposure in which pulpal bleeding can
      be controlled within several minutes.

      Calcium Hydroxide PP of primary molar teeth with deep carious lesions is used in studies
      conducted by Schroder and Trairatvorakul. Schroder. showed that the clinical-radiographic
      success rate of primary molar teeth one year after PP was 83 percent; they concluded that PP
      has the same favorable outcome as cervical formocresol pulpotomy (FP).

      If the pulp is diagnosed as normal or as having reversible pulpitis, a new regenerative
      material is recommended as the dressing material. In comparison with complete pulpotomy
      (i.e., removal of the entire pulp chamber), PP has several advantages; it causes limited
      injury to the pulp and limited loss of tooth substances, and this is important for pulpal
      healing and easier restoration.

      Pulpotomy is the pulp treatment most commonly used for primary teeth with a deep carious
      lesion approaching the pulp. With pulpotomy, a portion of the pulp is removed: the coronal
      pulp is removed and the radicular pulp is preserved. After treatment, the cavity is filled
      with a medicament followed by a final restoration.

      Formocresol pulpotomy (FCP) was developed in 1932 by Charles A. Sweet.". The original FCP was
      a three-appointment procedure which has been reduced to a one-appointment procedure; it is
      still the most common treatment for primary teeth with caries approaching the pulp.

      Studies have shown formocresol therapy to have a success rate between 70% and 90%.Histologic
      results have been variable in contrast to the high clinical success rate. Formocresol is
      still considered a gold standard by which all new modalities are compared.

      MTA is used in pulp capping whether indirect or directly it has the advantage of
      biocompatibility to the pulp tissues and stimulates the odontoblast for thicker secondary
      dentine formation without tunnel defects and formation of hydroxyapatite like material to
      seal the pulp tissues. Although it has slow setting time, discolor the tooth, relatively high
      cost compared to the gold stander calcium hydroxide.

      TheraCal light Cured (LC) is a single paste calcium silicate-based material promoted by the
      manufacturer for use as a pulp capping agent and as a protective liner for use with
      restorative materials, cement, or other base materials. The material might be very likable
      for clinicians because of its ease of handling. According to Alberto Danga in 2009 the
      cytotoxic effect of resin-based light-cured (Theracal) on human pulp tissue was least when
      compared to other materials.

      There is a lack of evidence in partial pulpotomy treating primary teeth. In this study a
      Randomized control trial will be performed to have an evidence based answer for treating
      primary teeth with partial pulpotomy.
    

Intervention name(s): Formocresol; MTA; TheraCal; pulpotomy; partial pulpotomy
Intervention type(s): Drug; Drug; Drug; Procedure; Procedure
Intervention description(s): mixture of formalin, cresol and glycerine used for fixation of pulp tissues; material used for pulp regeneration, direct and indirect pulp capping; light cured resin modified calcium silicate filled liner designed for use in direct and indirect pulp capping; removal of the carious tooth structure and unroofing of the pulp chamber with a round carbide bur with high speed and water spray. The coronal pulp tissue will be then removed using a #4 carbide bur with slow speed and sharp spoon excavator.; complete removal of caries till exposure occurs. The exposed surface of the pulp will be gently removed using a sterile round diamond bur and a high-speed, water-cooled handpiece with light hand pressure. The removal of the pulp did not exceed approximately two mm.
Other intervention name(s): Mineral trioxide aggregate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Partial Pulpotomy; pulpotomy; MTA; Theracal; Formocresol