Pulpotomy Technique Preserving Vitality of Traumatized Anterior Permanent Immature Teeth

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.

• Biodentine (Biological), also known as Calcium silicate-based: Biodentine is considered a calcium silicate cement
• mineral trioxide aggregate (Biological), also known as MTA: calcium based silicate cement
• cervical pulpotomy (Procedure): coronal pulp tissue was removed till the orifice
• Local Anesthetics Procaine (Drug), also known as artinibsa: 40 mg/0.01 mg/ml contains sodium metabisulfite and sodium and articaine as an active substance

Primary outcomes

• presence of pain,sensitivity to percussion/ palpation [18 months]: by asking the patient( questionnaire) (Binary measure) ( Yes or No) where Yes indicates failure of the treatment
• Swelling or sinus tract [18 months]: by visual examination (binary measure)( Yes or No) where Yes indicates clinical failure of the treatment
• presence of mobility [18 months]: by the back of the mirror( Binary measure) (Yes or No) where Yes indicates clinical failure of the treatment.

Secondary outcomes

• Stage of root development [18 months]: by radiographic parallel technique ( four root development stages are assessed E, F,G and H) where E is the worse and H is the best stage.
• Presence of radiolucency [18 months]: by radiographic parallel technique (Binary measure) (Yes or No) where Yes indicates radiographic failure of the treatment.

Sex: All, ages: 7 Years to 9 Years, 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

• Study Protocol and Statistical Analysis Plan (PDF, 2017-01-18)

• Gihan M Abuelniel, Principal investigator, Cairo University