Evaluation of Hyaluronic Acid Pulpotomies in Primary Molars
Condition: Pulpitis
MeSH terms: Pulpitis
Study type: Interventional

Summary: 
      In this study, 120 primary molar teeth from healthy children aged between 5 and 9 and who
      apply to Marmara University Faculty of Dentistry, Department of Pediatric Dentistry will be
      subjected to pulpotomy treatments. After proper diagnosis of coronal pulpitis, the teeth will
      be assigned randomly to one of the 3 groups: 40 primary molars for formocresol (FC) pulpotomy
      treatments, 40 primary molars for ferric sulfate (FS) treatments and 40 primary molars for
      0.5% hyaluronic acid gel (HA) pulpotomy treatments. The tooth decay will be removed, the pulp
      will be amputated from the chamber of the pulp with a sharp excavator and one of the
      medicament will be applied to the orifice of the root canals. The cavity will be sealed tight
      with zinc oxide cement, and the primary molars will be restored with a composite filling
      material or with a stainless steel crown (SSC). A single investigator will perform the
      procedure. The teeth will be followed clinically and radiographically at 1st, 3rd, 6th, 12th
      months.
    

Detailed description: 
      The aim of this study is to compare the efficacy of the materials used in pulpotomies, and to
      evaluate the success of hyaluronic gel over the formocresol and/or ferric sulfate considered
      as the gold standard for this type of treatment.

      Pulpotomy is an endodontic treatment method aiming to maintain primary molar affected from
      deep caries and acute pulpitis by removing the effected pulpal tissue, leaving the remaining
      root canal pulp and maintaining its vitality and function until the tooth exfoliates
      physiologically. In order to remain canals intact and uninflamed various dental materials are
      used according to treatment purposes; categorized into three groups as devitalizing,
      preventive and regenerative treatment.

        1. Devitalization: Formocresol, Glutaraldehyde, Electro-surgery

        2. Protective: Ferric Sulfate, Calcium Hydroxide, Mineral Trioxide Aggregate, Lasers

        3. Regenerative: Bone Morphogenetic Protein, Enriched Collagen

      The ideal agent or method for pulpotomy treatment of the primary teeth has not been
      determined yet but the earliest method of diluted formocresol is considered by many the gold
      standard. Formocresol is a strong strain that fixes living tissues. It contains formaldehyde
      gas, organic structures, dentin channels and narrow side channels until the bacteria are also
      fixed. 10% formalin solution (14% formaldehyde) is used as a tissue fixative.

      Ferric Sulfate an other material for pulpotomy is used in dentistry mainly as a hemostatic
      agent. It has several advantages over formocresol such as non-mutagenic property and keeping
      root canal pulp vital.

      Hyaluronic acid gel, which is a new product as a pulpotomy material, has been used in
      dentistry as well as medicine for many years. It is distributed widely in epithelial and
      connective tissues. Medical uses include joint treatments, skin lotions for atopic
      dermatitis, cosmetic surgery etc. In dentistry, gingivitis, teething, dental surgery
      including implants and sinus lifting procedures and oral ulcers are main target for
      hyaluronic acid treatment. This study extends the use of hyaluronic acid to primary tooth
      endodontics.

      In this study, 120 primary molar teeth from healthy children aged between 5 and 9 and who
      apply to Marmara University Faculty of Dentistry Department of Pediatric Dentistry will be
      subjected to pulpotomy treatments. Sample size calculation showed that at first 40 teeth in
      each group will be required to detect a significant difference (80% power, two-sided 5%
      significance level).

      Ethical approval of the study was taken from the Clinical Research Ethics Committee, Faculty
      of Dentistry at Marmara University (No: 2019/288) in accordance with the Declaration of
      Helsinki. The patients' family will be given information about the pros and cons of the study
      on the relevant teeth and then a written consent will be obtained.

      Patients will be selected for this study according to the following criteria:

        1. Children who have good cooperation, do not require general anesthesia or sedation, and
           who do not have any systemic disease, allergic reactions, or any use of medications.

        2. No spontaneous, continuous pain in the tooth, no pathological or physiological mobility,
           no abscess and/or fistula, no tenderness to palpation or percussion.

        3. The tooth can be restored with a stainless steel crown (SSC) or a composite filling
           material after treatment.

        4. The physiological resorption in the tooth root not exceeding 1/3.

        5. No pathological resorption in the tooth root canals internally and/or externally, no
           radiolucency in the periapical or furcation regions, no enlargement of periodontal
           ligaments.

      Exclusion criteria:

        1. Children who have any disorders, spontaneous pain, no restorable primary molars, may
           exfoliate soon and teeth with apical periodontitis, pulp necrosis, abscess, fistula,
           swelling or mobility.

        2. Families who are not willing to join the study.

      After proper diagnosis of coronal pulpitis, local anesthesia is administrated, the teeth will
      be assigned randomly to one of the 3 groups: 40 primary molars for formocresol pulpotomy
      treatments, 40 primary molars for ferric sulfate treatments and 40 primary molars for 0.5%
      hyaluronic acid gel pulpotomy treatments. The tooth decay is removed, the roof of the pulp
      chamber is removed by joining the pulp horns with a bur cut. The coronal pulp is amputated
      from the chamber of the pulp with a sharp excavator and one or more cotton pellets is placed
      over the site and pressure is applied. When the hemostasis is insured, one of the medicament
      is applied to the orifice of the root canals. The cavity will be sealed tight with zinc oxide
      eugenol cement. The primary molars were restored either with a stainless-steel crown in case
      of proximal cavities or with a composite filling material in case of occlusal cavities. A
      single pediatric dentist will perform whole pulpotomy treatments and restorations of all
      selected teeth. The teeth will be followed clinically and radiographically at 1, 3, 6, 12
      months.

      The teeth will be evaluated clinically and radiographically according to the following
      criteria:

        1. Clinical criteria: Spontaneous pain, tenderness to percussion and/or palpation,
           pathological mobility and abscess or fistula.

        2. Radiographic criteria: Periapical or furcal radiolucency, internal or external root
           resorption, loss of lamina dura.

      All evaluations will be performed by two calibrated pediatric dentists. The performing
      dentist will not be blinded to the treatment materials but the patient and two examiners who
      evaluated clinical and radiographic findings will be blinded to the treatment.
    

Intervention name(s): Hyaluronic acid: Gengigel teething; Formocresol Buckley formula: Formacresol; Ferric sulfate: ViscoStat
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns and composite filling material.; Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns and composite filling material.; Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns and composite filling material.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulpotomy