A Phase 2/3 interventional study of Biodentine and mineral trioxide aggregate in Pulp Exposure, Dental, sponsored by Gihan M Abuelniel ,PhD. Completed at 1 site in Egypt. Open to participants aged 7 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-27.
Sponsored by Gihan M Abuelniel ,PhD · Phase 2/3, Interventional, and Treatment
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.
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.
29 studies on the registry are indexed under Dental Pulp Exposure; 5 are open to participants now.
This study's enrollment of 33 is below the median of 53 across 27 interventional studies indexed under Dental Pulp Exposure.
Browse Dental Pulp Exposure studies →Gihan M Abuelniel ,PhD is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
white mineral trioxide aggregate (MTA) calcium silicate-based cement
Biological: mineral trioxide aggregate · Procedure: cervical pulpotomy · Drug: Local Anesthetics Procaine
calcium silicate-based cement that consists of tricalcium silicate, dicalcium silicate, calcium carbonate, calcium oxide, zirconium oxide, and CH.
Biological: Biodentine · Procedure: cervical pulpotomy · Drug: Local Anesthetics Procaine
Biodentine is considered a calcium silicate cement
Also known as: Calcium silicate-based
calcium based silicate cement
Also known as: MTA
coronal pulp tissue was removed till the orifice
40 mg/0.01 mg/ml contains sodium metabisulfite and sodium and articaine as an active substance
Also known as: artinibsa
presence of pain,sensitivity to percussion/ palpation
by asking the patient( questionnaire) (Binary measure) ( Yes or No) where Yes indicates failure of the treatment
Time frame: 18 months
Swelling or sinus tract
by visual examination (binary measure)( Yes or No) where Yes indicates clinical failure of the treatment
Time frame: 18 months
presence of mobility
by the back of the mirror( Binary measure) (Yes or No) where Yes indicates clinical failure of the treatment.
Time frame: 18 months
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.
Time frame: 18 months
Presence of radiolucency
by radiographic parallel technique (Binary measure) (Yes or No) where Yes indicates radiographic failure of the treatment.
Time frame: 18 months
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Plan to share: No
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Gihan M Abuelniel ,PhD