Pulpotomy Technique Preserving Vitality of Traumatized Anterior Permanent Immature Teeth

Clinical and Radiographic Evaluation of Pulpotomy Technique for Preserving Vitality of Traumatized Anterior Permanent Immature Teeth: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Pulp Exposure, Dental
• Intervention / Treatment: Biological: mineral trioxide aggregate; Procedure: cervical pulpotomy; Drug: Local Anesthetics Procaine; Biological: Biodentine

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12566
    • Gihan Abuelniel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mineral trioxide aggegate; white mineral trioxide aggregate (MTA) calcium silicate-based cement	Biological: mineral trioxide aggregate; calcium based silicate cement; Other Names: MTA; Procedure: cervical pulpotomy; coronal pulp tissue was removed till the orifice; Drug: Local Anesthetics Procaine; 40 mg/0.01 mg/ml contains sodium metabisulfite and sodium and articaine as an active substance; Other Names: artinibsa
Experimental: Biodentine; calcium silicate-based cement that consists of tricalcium silicate, dicalcium silicate, calcium carbonate, calcium oxide, zirconium oxide, and CH.	Procedure: cervical pulpotomy; coronal pulp tissue was removed till the orifice; Drug: Local Anesthetics Procaine; 40 mg/0.01 mg/ml contains sodium metabisulfite and sodium and articaine as an active substance; Other Names: artinibsa; Biological: Biodentine; Biodentine is considered a calcium silicate cement; Other Names: Calcium silicate-based

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stage of root development	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.	18 months
Presence of radiolucency	by radiographic parallel technique (Binary measure) (Yes or No) where Yes indicates radiographic failure of the treatment.	18 months

Collaborators and Investigators

• Sponsor: Gihan M Abuelniel ,PhD
• Collaborators: Cairo University
• Investigators: Principal Investigator: Gihan M Abuelniel, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2017
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): August 15, 2019

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: February 8, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): December 27, 2019
• Last Update Submitted That Met QC Criteria: December 23, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: trauma; MTA; Biodentine; vital immature
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Dental Pulp Exposure; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Procaine
• Other Study ID Numbers: 19118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes