Clinical Evaluation of Two Low-shrinkage Composites
1 other identifier
interventional
18
0 countries
N/A
Brief Summary
Patients with 4 occlusal lesions in molar teeth will be included. Occlusal cavities will be prepared either by Er,Cr:YSGG laser (LS) or conventional diamond bur (BR). Cavities will be restored with Filtek Silorane (3M-ESPE) (SR) and with Kalore (GC) (KR) according to the manufacturers' instructions. All restorative procedures will be performed by one operator and the restorations will be examined by two evaluators according to the FDI (World Dental Federation) criteria at baseline and at 6-month, 1-, 2-,3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-year. Patients' satisfaction about the preparation methods will be evaluated with a survey. Pearson Chi-Square test will be used for statistical analyze(p=0.05).
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 2011
Longer than P75 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
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 14, 2018
CompletedFirst Posted
Study publicly available on registry
October 17, 2018
CompletedApril 17, 2024
April 1, 2024
4 months
October 14, 2018
April 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical performance of different low-shrinkage composites and preparations
Evaluations according to FDI criteria
10 years
Study Arms (4)
Filtek Silorane-Er,Cr:YSGG Laser
EXPERIMENTALFiltek Silorane- Diamond Bur
EXPERIMENTALKalore- Er,Cr:YSGG Laser
EXPERIMENTALKalore- Diamond Bur
EXPERIMENTALInterventions
Filtek Silorane
Er,Cr:YSGG Laser
Eligibility Criteria
You may qualify if:
- age range will be 18 to 60
- patients should have at least 4 occlusal caries lesions require restoration
- healty periodontal status
- a good likelihood of recall availability
You may not qualify if:
- poor gingival health
- adverse medical history
- potential behavioral problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor, DDS, PhD
Study Record Dates
First Submitted
October 14, 2018
First Posted
October 17, 2018
Study Start
May 1, 2011
Primary Completion
September 1, 2011
Study Completion
September 1, 2018
Last Updated
April 17, 2024
Record last verified: 2024-04