Pulpotomy Technique Preserving Vitality of Traumatized Anterior Permanent Immature Teeth
NCT ID: NCT03838068
Last Updated: 2019-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
33 participants
INTERVENTIONAL
2017-01-18
2019-08-15
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Mineral trioxide aggegate
white mineral trioxide aggregate (MTA) calcium silicate-based cement
mineral trioxide aggregate
calcium based silicate cement
cervical pulpotomy
coronal pulp tissue was removed till the orifice
Local Anesthetics Procaine
40 mg/0.01 mg/ml contains sodium metabisulfite and sodium and articaine as an active substance
Biodentine
calcium silicate-based cement that consists of tricalcium silicate, dicalcium silicate, calcium carbonate, calcium oxide, zirconium oxide, and CH.
Biodentine
Biodentine is considered a calcium silicate cement
cervical pulpotomy
coronal pulp tissue was removed till the orifice
Local Anesthetics Procaine
40 mg/0.01 mg/ml contains sodium metabisulfite and sodium and articaine as an active substance
Interventions
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Biodentine
Biodentine is considered a calcium silicate cement
mineral trioxide aggregate
calcium based silicate cement
cervical pulpotomy
coronal pulp tissue was removed till the orifice
Local Anesthetics Procaine
40 mg/0.01 mg/ml contains sodium metabisulfite and sodium and articaine as an active substance
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
7 Years
9 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Gihan M Abuelniel ,PhD
OTHER
Responsible Party
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Gihan M Abuelniel ,PhD
Associate Professor of Pediatric Dentistry
Principal Investigators
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Gihan M Abuelniel
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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Gihan Abuelniel
Giza, , Egypt
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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19118
Identifier Type: -
Identifier Source: org_study_id