Pulpotomy Technique Preserving Vitality of Traumatized Anterior Permanent Immature Teeth

Gihan M Abuelniel ,PhD

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pulp Exposure, Dental

Treatments: Procedure: cervical pulpotomy; Biological: mineral trioxide aggregate; Biological: Biodentine; Drug: Local Anesthetics Procaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03838068

19118

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 7 to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The patient age range 7.5-9 years.
• Noncontributory medical history
• Unilateral/ and or bilateral central incisors tooth with complicated trauma (exposure size ≥ 1mm)
• The tooth should give positive response to cold testing
• Clinical diagnosis of reversible pulpitis without periapical rarefaction
• The tooth is restorable, mobility was within normal limits
• No signs of pulpal necrosis including sinus tract or swelling

Exclusion criteria

• Teeth with mature roots
• Signs and symptoms of irreversible pulpitis
• Non-restorable teeth
• Negative response to cold testing, the presence of sinus tract or swelling
• No pulp exposure
• Bleeding could not be controlled after full pulpotomy in 6 minutes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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33 participants in 2 patient groups

Mineral trioxide aggegate

Active Comparator group

Description:

white mineral trioxide aggregate (MTA) calcium silicate-based cement

Treatment:

Drug: Local Anesthetics Procaine

Procedure: cervical pulpotomy

Biological: mineral trioxide aggregate

Biodentine

Experimental group

Description:

calcium silicate-based cement that consists of tricalcium silicate, dicalcium silicate, calcium carbonate, calcium oxide, zirconium oxide, and CH.

Treatment:

Drug: Local Anesthetics Procaine

Procedure: cervical pulpotomy

Biological: Biodentine