Is Biodentine, as Successful as, Mineral Trioxide Aggregate
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Biodentine
MTA pulpotomy
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring Pulpotomy, Primary molars, Biodentine, MTA.
Eligibility Criteria
Inclusion Criteria:
No history of spontaneous pain
- Absence of tenderness to percussion.
- Absence of physiologic or pathologic tooth mobility.
- No clinical evidence of pulpal inflammation or degeneration, such as history of swelling or presence of sinus tract.
- Restorable teeth.
- Absence of radiographic evidence of internal or external root resorption, pulpal calcification, or osseous disease (periapical or furcation infection).
Exclusion Criteria:
- Evidence of necrosis after access cavity preparation.
- Hemostasis could not be achieved within three min after direct contact with a wet cotton pellet, prior to material placement.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Biodentine pulpotomy
MTA pulpotomy
Arm Description
Biodentine (Septodont, France) Pulpotomy for primary molars Clinical and radiographic evaluation Follow up at 1,3,6 and 12 months
MTA (Angelus- Londrina, Brazil) Pulpotomy for primary molars . it is fine hydrophilic powder consisting of tricalcium silicate, tricalicum aluminate, tricalcium oxide, silicate oxide and bismuth oxide11. It is currently being used in pulpotomy of primary molars with a high rate of success. Clinical and radiographic evaluation. Follow up at 1,3,6 and 12 months
Outcomes
Primary Outcome Measures
radiographic success
syptom free
Secondary Outcome Measures
Full Information
NCT ID
NCT03686475
First Posted
September 25, 2018
Last Updated
September 25, 2018
Sponsor
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT03686475
Brief Title
Is Biodentine, as Successful as, Mineral Trioxide Aggregate
Official Title
Is Biodentine, as Successful as, Mineral Trioxide Aggregate for Pulpotomy of Primary Molars? A Split Mouth Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
: A split-mouth controlled clinical trial was carried out on 21 healthy, three to seven years old children, with 42 pairs (84 molars) of contralateral mandibular primary molars indicated for pulpotomy. One paired tooth in one side was designated to Biodentine (Group 1) and the other side for MTA (Group 2) as a pulp medicament. All pulpotomized teeth were finally restored with stainless steel crowns. Subjects were monitored clinically and radiographically at one, three, six and 12 months.
Detailed Description
Study design:
The present study was a split-mouth controlled clinical trial.
Sample size:
A sample size of 21 patients with 42 pairs of molars (84 molars) was determined using online sample size calculator (Sealed envelope.com).
Subjects:
The study population included three to seven years old healthy and cooperative patients who presented at the Pediatric Dental Clinic, Faculty of Dentistry, Cairo University and had two matched bilateral deep carious mandibular primary molars indicated for pulpotomy, that met specific inclusion criteria. Written consent was obtained from the parent/guardian after explaining the full details of the treatment procedure.
The criteria for inclusion in this study were:
No history of spontaneous pain
Absence of tenderness to percussion.
Absence of physiologic or pathologic tooth mobility.
No clinical evidence of pulpal inflammation or degeneration, such as history of swelling or presence of sinus tract.
Restorable teeth.
Absence of radiographic evidence of internal or external root resorption, pulpal calcification, or osseous disease (periapical or furcation infection).
On the other hand, teeth were excluded if:
Evidence of necrosis after access cavity preparation.
Hemostasis could not be achieved within three min after direct contact with a wet cotton pellet, prior to material placement.
Matched molars in each pair were randomly designated using computer software (Random.org) to Group 1: which received Biodentine (Septodont, France), or Group 2: which received MTA (Angelus- Londrina, Brazil), as pulp medicament.
Procedures:
Preoperative periapical radiograph using periapical film size two (Speed D Film, Kodak, US) was taken for the molars considered for treatment. Radiographs should be of proper film density and contrast for proper radiographic diagnosis.
The pulpotomy procedure was performed by the same operator. Local anesthesia was induced and rubber dam isolation was performed, followed by caries removal and deroofing of the pulp chamber using a #330 high-speed carbide bur mounted in a water-cooled high speed turbine. The coronal pulp tissue was amputated using a sterile sharp spoon excavator. The pulp chamber was irrigated with normal saline. Pulp hemostasis was achieved using a sterile wet cotton pellet applied for two to three min.
In Group 1: Biodentine was used according to the manufacturer's instructions. A capsule was gently tapped on a hard surface (to diffuse powder); five drops of liquid from the single dose dispenser were poured into the capsule which was placed in a triturator for 30 sec. The mixture was then introduced into the pulp chamber using amalgam carrier until the entire pulp chamber was completely filled.
In Group 2: MTA was used according to the manufacturer's instructions; the powder was mixed with sterile water in a 3:1 powder/water ratio to obtain a thick creamy paste, then placed on the floor of the pulp chamber using a messing gun and compacted against the pulp orifices with a condenser over a moist cotton pellet.
Molars of both groups were finally restored with stainless steel crowns (3M, ESPE, Unitek, US) cemented with GI cement. An immediate postoperative radiograph using periapical film size two was taken.
Clinical and radiographic evaluation:
All treated patients were followed up at one, three, six and 12 months after the pulpotomy for clinical and radiographic evaluation as recommended by the American Academy of Pediatric Dentistry . Independently, two examiners evaluated the teeth clinically and radiographically.
The pulpotomized teeth were judged as clinically successful if they met the following criteria: Absence of sensitivity, pain, tenderness to percussion, abscess, fistula or tooth mobility. Radiographic success was defined if there were normal periodontal ligament space, absence of furcation or periapical radiolucency, absence of internal or external root resorption. Widening of the periodontal ligament was not considered failure in absence of other concurrent pathologies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Pulpotomy, Primary molars, Biodentine, MTA.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
blinding
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biodentine pulpotomy
Arm Type
Experimental
Arm Description
Biodentine (Septodont, France) Pulpotomy for primary molars Clinical and radiographic evaluation Follow up at 1,3,6 and 12 months
Arm Title
MTA pulpotomy
Arm Type
Active Comparator
Arm Description
MTA (Angelus- Londrina, Brazil) Pulpotomy for primary molars . it is fine hydrophilic powder consisting of tricalcium silicate, tricalicum aluminate, tricalcium oxide, silicate oxide and bismuth oxide11.
It is currently being used in pulpotomy of primary molars with a high rate of success.
Clinical and radiographic evaluation. Follow up at 1,3,6 and 12 months
Intervention Type
Other
Intervention Name(s)
Biodentine
Other Intervention Name(s)
tricalcium silicate cements
Intervention Description
pulpotomy for primary molars , clinical and radiographic evaluation at 1,3,6 and 12month
Intervention Type
Other
Intervention Name(s)
MTA pulpotomy
Intervention Description
MTA pulpotomy
Primary Outcome Measure Information:
Title
radiographic success
Description
syptom free
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No history of spontaneous pain
Absence of tenderness to percussion.
Absence of physiologic or pathologic tooth mobility.
No clinical evidence of pulpal inflammation or degeneration, such as history of swelling or presence of sinus tract.
Restorable teeth.
Absence of radiographic evidence of internal or external root resorption, pulpal calcification, or osseous disease (periapical or furcation infection).
Exclusion Criteria:
Evidence of necrosis after access cavity preparation.
Hemostasis could not be achieved within three min after direct contact with a wet cotton pellet, prior to material placement.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Randa Abd El Gawad
Organizational Affiliation
Cairo University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://scholar.cu.edu.eg
Description
cairo university scholar
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Is Biodentine, as Successful as, Mineral Trioxide Aggregate
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