Efficacy of Combination of Biodentine and Simvastatin as a Pulp Capping Materials in Vital Pulpotomy of Primary Molars
1 other identifier
interventional
20
1 country
1
Brief Summary
Objective: This study was conducted to evaluate the efficacy of combination of biodentine with simvastatin as a pulpotomy agent for vital primary molars clinically and radiographically. Study design: 60 primary molars in 20 children aged 4-7 years old were randomly allocated to three groups, Biodentine, Simvastatin and combination of Biodentine and simvastatin. Clinical and radiographic examinations were conducted at 1, 3, 6, 9 and 12 months after treatment. Key words: Pulpotomy, Primary teeth, Biodentine, Simvastatin.
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 May 2021
1 active site
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
May 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2022
CompletedFirst Submitted
Initial submission to the registry
September 12, 2022
CompletedFirst Posted
Study publicly available on registry
October 17, 2022
CompletedOctober 17, 2022
August 1, 2022
1 year
September 12, 2022
October 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical assessment
Pain, tenderness, Swelling No tender on percussion. No swelling/sinus. No pathological tooth mobility.
12 months
Secondary Outcomes (1)
Radiographically:
12 months
Study Arms (3)
Biodentine
ACTIVE COMPARATOR20 primary molars were treated by Biodentine
Simvastatin
ACTIVE COMPARATOR20 primary molars were treated by Biodentine
combination of Biodentine and Simvastatin
ACTIVE COMPARATOR20 primary molars were treated by Biodentine
Interventions
Tricalcium silicate, dicalcium silicate, calcium carbonate and oxide filler, iron oxide shade and zirconium oxide
3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor
Eligibility Criteria
You may qualify if:
- Apparently healthy children free from any known systemic diseases.
- Parent willing to participate in the study and signed an informed consent.
- Patient had at least three restorable primary molars with a caries- exposed vital pulp
You may not qualify if:
- history of spontaneous pain or provoked pain.
- clinical signs and ̸ or symptoms suggesting a non-vital tooth such as (fistula, sinus tract, soft tissue swelling, mobility or tenderness to percussion).
- non-Restorable tooth
- pathologic or physiologic mobility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of dentistry, Suez canal university
Ismailia, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2022
First Posted
October 17, 2022
Study Start
May 23, 2021
Primary Completion
May 24, 2022
Study Completion
July 25, 2022
Last Updated
October 17, 2022
Record last verified: 2022-08