Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03306576 |
Other study ID # |
10840098-604.01.01-E.21426 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 10, 2017 |
Est. completion date |
December 30, 2020 |
Study information
Verified date |
February 2023 |
Source |
Istanbul Medipol University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Adhesive restorative materials are routinely used in operative dentistry to improve tooth
tissues with minimal preparation, achieve more esthetic and long term restorations. Despite
these efficacy to dentistry these materials still present some drawbacks like polymerization
shrinkage. Postoperative sensitivity, marginal discoloration and possibly secondary caries
are often associated with loss of marginal integrity in composite restorations occurred as a
result of polymerization shrinkage. To achieve optimal long term performance, the
requirements will be first to manage polymerization stress buildup following
restoration.Low-shrinking composites with new formulas have been successful in brilliantly
further developing the leader product els extra low shrinkage.
The objective of this controlled clinical trial is to evaluate the clinical performance of
restorative material ELS versus ELS Extra resin composite for Class I and Class II cavities
that needs to be restored in permanent teeth.
Description:
The detrimental impact of resin composite polymerization shrinkage on restoration interface
quality and stability has been recognized since the early use of this material is still one
of the major drawbacks in adhesive dentistry, as it frequently leads to loss of marginal
integrity or enamel fracture. According to clinical studies, drawbacks such as postoperative
sensitivity, marginal discoloration and possibly secondary caries are often associated with
loss of marginal integrity in composite restorations occurred as a result of polymerization
shrinkage. Various technological solutions were investigated, including improved filler
technology; improved, novel matrix structure with reduced shrinkage; use of stress-decreasing
compounds within the resin matrix; changes in light-initiation technology to increase curing
depth; and use of sonic vibrations and energy to favor flow and adaptation of highly filled
resin composite. To achieve optimal long term performance, the requirements will be first to
manage polymerization stress buildup following restoration. Low-shrinking composites should
help to avoid clinical problems that are commonly associated with composite restorations,
such as post-operative sensitivity, enamel cracks, rapid discoloration and deterioration of
restoration margins, early development of caries recurrence, with a new formula and improved
sculptability SAREMCO has been successful in brilliantly further developing the leader
product els extra low shrinkage. When using new simplified restorative systems featuring
distinctive physicochemical characteristics, the potential impact of different parameters
such as fatigue behavior and/or elastic modulus on restoration quality and behavior is
unknown and justifies additional investigations. Instead of in vitro evaluations,
consideration of a rather well-established clinical trials suggesting medium to long term
observation periods to discriminately appraise the clinical performance of various operative
protocols.
The project includes 30 patients. Most of the patients have been recruited from the Istanbul
Medipol University Dental Clinics in Istanbul. After giving their consent to take part in the
study Class I & II restorations of both upper and lower molars and premolars are
performed.The treatment procedure is: The patients are offered local anesthetic before
treatment start. The cavity is excavated and filled according to the guidelines for composite
restorations.
The control procedure is:
The restoration is evaluated according to marginal adaptation, cavo surface marginal
discoloration, approximal contact, fractures, caries associated with restorations and
postoperative hypersensitivity. The controls will take place after two weeks, one year, two
years and three years.