Clinical trial NCT03838068: Pulpotomy Technique Preserving Vitality of Traumatized Anterior Permanent Immature Teeth
Official title: Clinical and Radiographic Evaluation of Pulpotomy Technique for Preserving Vitality of Traumatized Anterior Permanent Immature Teeth: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pulp Exposure, Dental
Keywords: trauma
vital immature
MTA
Biodentine
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2019-02-12
Enrollment: 33
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: presence of pain,sensitivity to percussion/ palpation
timeFrame: 18 months
measure: Swelling or sinus tract
timeFrame: 18 months
measure: presence of mobility
timeFrame: 18 months
Secondary outcomes:
measure: Stage of root development
timeFrame: 18 months
measure: Presence of radiolucency
timeFrame: 18 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Gihan Abuelniel
Study officials:
affiliation: Cairo University
name: Gihan M Abuelniel
role: PRINCIPAL_INVESTIGATOR
References: