Evaluation of MTA Versus Biodentine as Pulpotomy Agents in Immature First Permanent Molars
Condition: Carious Exposure of Pulp
Study type: Interventional
Phase: Phase 1/Phase 2

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) of cariously
      exposed vital immature mandibular first permanent molars.

      Materials and Methods: sixty immature first mandibular permanent molars cariously exposed
      with symptomatic /asymptomatic pulpitis were included in the study according to inclusion
      criteria and were equally divided in two groups. Following split-mouth design molars were
      randomly assigned to either a control group (MTA 30 molars) or a test group (Biodentine 30
      molars). After conducting pulpotomy and covering pulp stumps with the MTA and Biodentine,
      treated molars 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
      analysed.
    

Detailed description: 
      Diagnosis:

        1. Full history data will be collected, including personal, medical and previous dental
           data

        2. Clinical examination using mirror and probe to assess the inclusion criteria.

        3. Radiographic examination using preoperative digital periapical radiograph to assess the
           inclusion criteria.

        4. Preoperative photograph will be taken.

      Operative procedure:

      Experimental group:

        1. Injection of local anesthesia and rubber dam isolation.

        2. caries and roof of the pulp chamber will be removed by a fissure diamond bur (Diatech,
           Heerbrug, Switzerland) and high-speed handpiece with coolant.

        3. The pulps will be amputated to the orifice level using a long-shank diamond round bur.

        4. Haemostasis will be achieved by gentle placement of a saline-moistened cotton pellet
           over amputated pulps for 5-10 min.

        5. Calcium silicate-based BiodentineTM (Septodont Ltd., Saint Maur des Fausse´s, France)
           will be mixed according to the manufacturer's instructions, radicular pulp will be
           covered by the material using a wet cotton pellet.

        6. A self-cure glass ionomer (GC; GC Corporation, Tokyo, Japan) will be placed over the
           pulpotomy agent as a final restoration.

        7. Immediate post-operative radiograph and photograph will be taken.

      Control group:

      The same procedures will be carried out as the experimental group, but the pulp stumps will
      be covered with fast-setting mineral trioxide aggregate (MTA) ENDOCEM MTA (Maruchi, Wonju,
      Korea) and will be prepared according to the manufacturer's instructions. A 3-mm-thick layer
      of MTA will be placed over the amputated pulps and will be gently adapted to the dentinal
      walls using a wet cotton pellet. A self-cure glass ionomer (GC; GC Corporation, Tokyo, Japan)
      will be placed over the pulpotomy agent as a final restoration.

      Postoperative care:

      Instructions to avoid lip and cheek biting in addition to oral hygiene measures.

      Follow up:

      Assess the outcomes clinically and radiographically at (baseline, 6, 12 and 18 months).
    

Intervention name(s): Biodentine; MTA
Intervention type(s): Biological; Biological
Intervention description(s): it is a dentin substitute, a new biologically active material facilitates its penetration through opened dentinal tubules to crystallize interlocking with dentin and provide mechanical properties.; MTA is a powder that consists of fine hydrophilic particles that set in the presence of moisture. MTA consists of tricalcium silicate, tricalcium aluminate, tricalcium oxide and silicate oxide. MTA was considered a remarkable biocompatible material with various clinical applications that include surgical and non-surgical applications such as pulp capping
Other intervention name(s): Calcium silicate-based biomaterial; mineral trioxide aggregate
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pulp exposure; vital immature; MTA; Biodentine