Pulpotomy Technique Preserving Vitality of Traumatized Anterior Permanent Immature Teeth

Sponsor

Gihan M Abuelniel ,PhD (Other)

Overall Status

Completed

CT.gov ID

NCT03838068

Collaborator

Cairo University (Other)

Enrollment

Location

Arms

30.9

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulp Exposure, Dental	Biological: Biodentine Biological: mineral trioxide aggregate Procedure: cervical pulpotomy Drug: Local Anesthetics Procaine	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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).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).

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

Patients and their parents, the assessor and the statistician will be blinded.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 18, 2017

Actual Primary Completion Date :

Dec 30, 2018

Actual Study Completion Date :

Aug 15, 2019

Arms and Interventions

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.	Biological: Biodentine Biodentine is considered a calcium silicate cement Other Names: Calcium silicate-based 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

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.

Biological: Biodentine

Biodentine is considered a calcium silicate cement

Other Names:

Calcium silicate-based

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 9 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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