Is Biodentine, as Successful as, Mineral Trioxide Aggregate
1 other identifier
interventional
21
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 25, 2018
CompletedFirst Posted
Study publicly available on registry
September 27, 2018
CompletedSeptember 27, 2018
September 1, 2018
2.3 years
September 25, 2018
September 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
radiographic success
syptom free
1 year
Study Arms (2)
Biodentine pulpotomy
EXPERIMENTALBiodentine (Septodont, France) Pulpotomy for primary molars Clinical and radiographic evaluation Follow up at 1,3,6 and 12 months
MTA pulpotomy
ACTIVE COMPARATORMTA (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
Interventions
pulpotomy for primary molars , clinical and radiographic evaluation at 1,3,6 and 12month
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr Randa Abd El Gawad
Cairo University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- blinding
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 25, 2018
First Posted
September 27, 2018
Study Start
March 1, 2015
Primary Completion
July 1, 2017
Study Completion
September 1, 2017
Last Updated
September 27, 2018
Record last verified: 2018-09