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Pulpotomy Technique Preserving Vitality of Traumatized Anterior Permanent Immature Teeth

Primary Purpose

Pulp Exposure, Dental

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Biodentine
mineral trioxide aggregate
cervical pulpotomy
Local Anesthetics Procaine
Sponsored by
Gihan M Abuelniel ,PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp Exposure, Dental focused on measuring trauma, vital immature, MTA, Biodentine

Eligibility Criteria

7 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Gihan Abuelniel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Mineral trioxide aggegate

Biodentine

Arm Description

white mineral trioxide aggregate (MTA) calcium silicate-based cement

calcium silicate-based cement that consists of tricalcium silicate, dicalcium silicate, calcium carbonate, calcium oxide, zirconium oxide, and CH.

Outcomes

Primary Outcome Measures

presence of pain,sensitivity to percussion/ palpation
by asking the patient( questionnaire) (Binary measure) ( Yes or No) where Yes indicates failure of the treatment
Swelling or sinus tract
by visual examination (binary measure)( Yes or No) where Yes indicates clinical failure of the treatment
presence of mobility
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
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
by radiographic parallel technique (Binary measure) (Yes or No) where Yes indicates radiographic failure of the treatment.

Full Information

First Posted
February 6, 2019
Last Updated
December 23, 2019
Sponsor
Gihan M Abuelniel ,PhD
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03838068
Brief Title
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 18, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
August 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gihan M Abuelniel ,PhD
Collaborators
Cairo University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Exposure, Dental
Keywords
trauma, vital immature, MTA, Biodentine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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).
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Patients and their parents, the assessor and the statistician will be blinded.
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mineral trioxide aggegate
Arm Type
Active Comparator
Arm Description
white mineral trioxide aggregate (MTA) calcium silicate-based cement
Arm Title
Biodentine
Arm Type
Experimental
Arm Description
calcium silicate-based cement that consists of tricalcium silicate, dicalcium silicate, calcium carbonate, calcium oxide, zirconium oxide, and CH.
Intervention Type
Biological
Intervention Name(s)
Biodentine
Other Intervention Name(s)
Calcium silicate-based
Intervention Description
Biodentine is considered a calcium silicate cement
Intervention Type
Biological
Intervention Name(s)
mineral trioxide aggregate
Other Intervention Name(s)
MTA
Intervention Description
calcium based silicate cement
Intervention Type
Procedure
Intervention Name(s)
cervical pulpotomy
Intervention Description
coronal pulp tissue was removed till the orifice
Intervention Type
Drug
Intervention Name(s)
Local Anesthetics Procaine
Other Intervention Name(s)
artinibsa
Intervention Description
40 mg/0.01 mg/ml contains sodium metabisulfite and sodium and articaine as an active substance
Primary Outcome Measure Information:
Title
presence of pain,sensitivity to percussion/ palpation
Description
by asking the patient( questionnaire) (Binary measure) ( Yes or No) where Yes indicates failure of the treatment
Time Frame
18 months
Title
Swelling or sinus tract
Description
by visual examination (binary measure)( Yes or No) where Yes indicates clinical failure of the treatment
Time Frame
18 months
Title
presence of mobility
Description
by the back of the mirror( Binary measure) (Yes or No) where Yes indicates clinical failure of the treatment.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Stage of root development
Description
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
Title
Presence of radiolucency
Description
by radiographic parallel technique (Binary measure) (Yes or No) where Yes indicates radiographic failure of the treatment.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gihan M Abuelniel
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gihan Abuelniel
City
Giza
ZIP/Postal Code
12566
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Pulpotomy Technique Preserving Vitality of Traumatized Anterior Permanent Immature Teeth

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