Pulpotomy Technique Preserving Vitality of Traumatized Anterior Permanent Immature Teeth
Condition: Pulp Exposure, Dental
MeSH terms: Dental Pulp Exposure
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Aim of the study: To compare the clinical and radiographic outcomes of mineral trioxide
      aggregate (MTA) and Biodentine as vital pulp therapy materials (pulpotomy) preserving the
      vitality of traumatized immature anterior permanent teeth.

      Materials and Methods: fifty vital traumatized immature anterior permanent teeth exposed with
      symptomatic /asymptomatic pulpitis were included in the study according to inclusion criteria
      and were equally divided in two groups. Included teeth were randomly assigned to either a
      control group (MTA 25 teeth) or a test group (Biodentine 25 teeth). After conducting
      pulpotomy and covering pulp stumps with the MTA and Biodentine, treated teeth received
      permanent restorations. Blinded clinical and radiographic evaluations were performed at
      different time intervals (base line immediate postoperative, 6, 12 and 18 months) according
      to clinical and radiographic criteria of success. Data were recorded and analyzed.
    

Detailed description: 
      Informed consent was obtained from all patients prior to treatment, and patients were offered
      Root canal treatment in case of treatment failure.

      Thirty-three patients who were referred to the postgraduate pediatric dentistry department
      clinic for the management of their traumatized permanent incisors teeth were assessed. Only
      Patients who had a traumatic incisor tooth with a vital pulp (detected by clinical
      signs/symptoms) were included.

      Incisors were assigned randomly in the two groups. The MTA group was considered the control
      group while the biodentine was the test group.

      All patients who were clinically eligible for enrollment in the study went through screening
      pre-operative digital periapical radiographic examination to assess the degree of root
      development/ formation and any dental infections or anomalies that could interfere with the
      planned treatment.

      The main investigator performed all pulpotomies. Local anesthesia was administrated followed
      by rubber dam isolation, the coronal pulp tissue was excised to the level of the orifice
      using a diamond bur with water cooling. Hemostasis was achieved by gentle placement of a
      saline-moistened cotton pellet over amputated pulps for 5-10 min. Pulp stumps were covered
      with:

      In the first group (control group) white mineral trioxide aggregate (MTA) ProRoot® MTA
      (Dentsply/ Johnson City,TN,USA) was used as the reference material for comparison and was
      prepared according to the manufacturer's instructions. A 3-mm-thick layer of MTA was placed
      over the amputated pulps and was gently adapted to the dentinal walls using a wet cotton
      pellet deep onto the radicular pulp. A self-cure glass ionomer (GC; GC Corporation, Tokyo,
      Japan) was placed over the pulpotomy agent before final restoration of composite resin
      (ClearﬁlTM, Kuraray, New York, USA) was done.

      In the second group Calcium silicate-based BiodentineTM (Septodont Ltd., Saint Maur des
      Fausse´s, France) was mixed according to the manufacturer's instructions, pulpotomy was
      performed, radicular pulp was covered, and teeth received self-cure glass ionomer prior to
      final restoration with the same technique as in the first group.
    

Intervention name(s): Biodentine; mineral trioxide aggregate; cervical pulpotomy; Local Anesthetics Procaine
Intervention type(s): Biological; Biological; Procedure; Drug
Intervention description(s): Biodentine is considered a calcium silicate cement; calcium based silicate cement; coronal pulp tissue was removed till the orifice; 40 mg/0.01 mg/ml contains sodium metabisulfite and sodium and articaine as an active substance
Other intervention name(s): Calcium silicate-based; MTA; artinibsa
Intervention MeSH terms: Anesthetics; Procaine; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Access cavity in traumatized central incisors will be assigned into experimental or control group using simple randomization 1:1 by the help of the computer software(random.org).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: trauma; vital immature; MTA; Biodentine