- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03822403
Clinical Performance Evaluation of a Glass-ionomer Restorative System Evaluation
Randomized, Controlled Clinical Evaluation of Glass Ionomer System vs Composite Posterior Restorations
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ankara, Turkey, 06100
- Hacettepe University School of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- a need for at least two but not more than four posterior toothcolored restorations;
- the presence of teeth to be restored in occlusion;
- teeth that were symptomless and vital;
- a normal periodontal status;
- a good likelihood of recall availability.
Exclusion Criteria:
- partly erupted teeth;
- absence of adjacent and antagonist teeth
- poor periodontal status;
- adverse medical history;
- potential behavioral problems.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: EQUIA
EQUIA Placing glass ionomer restorations, the dentin and enamel of cavities were conditioned with 20% polyacrylic acid for 20 seconds, washed, and briefly dried.
Equia Fil was injected into the cavity.
Isolation was maintained using cotton rolls and a saliva ejector.
After the setting time of 2.5 minutes, the restoration was polished wet using high-speed fine diamonds.
When the restoration was briefly dried, Equia Coat was applied and photocured for 20 seconds using a photo-curing light.
|
Placing glass ionomer restorations, the dentin and enamel of cavities were conditioned with 20% polyacrylic acid for 20 seconds, washed, and briefly dried.
Equia Fil was injected into the cavity.
Isolation was maintained using cotton rolls and a saliva ejector.
After the setting time of 2.5 minutes, the restoration was polished wet using high-speed fine diamonds.
When the restoration was briefly dried, Equia Coat was applied and photocured for 20 seconds using a photo-curing light.
Other Names:
|
ACTIVE_COMPARATOR: Gradia Direct Posterior
Gradia Direct Posterior The enamel and dentin were conditioned with G-Bond adhesive using a microtip applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, Gradia Direct Posterior resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds.
Finally, the restoration was shaped with finishing diamonds and silicon instruments.
|
The enamel and dentin were conditioned with G-Bond adhesive using a microtip applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, Gradia Direct Posterior resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds.
Finally, the restoration was shaped with finishing diamonds and silicon instruments.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria Observers evaluated the restorations was performed using the modified United State Public Health Service criteria Marginal adaptation
Time Frame: From baseline to 9 year the change of restorations was evaluated
|
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation.
Marginal adaptation was evaluated by 2 independent clinicians.
Visual inspection with a mirror at 18 inches was performed .
A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced.
Alpha 1: Harmonious outline Alpha 2: Marginal gap (max 100μ) with discoloration (removable)
|
From baseline to 9 year the change of restorations was evaluated
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marginal discoloration
Time Frame: From baseline to 9 year the change of restorations was evaluated
|
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal discoloration.
Marginal discolouration was evaluated by 2 independent clinicians.
Visual inspection with a mirror at 18 inches was performed .
A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced.
Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth.
Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.
Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction
|
From baseline to 9 year the change of restorations was evaluated
|
retention rate
Time Frame: From baseline to 9 year the change of restorations was evaluated
|
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1:Clinically excellent Alpha 2: Clinically good with slight deviations from ideal performance, correction possible without damage of tooth or restoration Bravo: Clinically sufficient with few defects, corrections or repair of the restoration possible Charlie: Restoration is partially missed Delta: Restoration is totally missed |
From baseline to 9 year the change of restorations was evaluated
|
anatomic form
Time Frame: From baseline to 9 year the change of restorations was evaluated
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Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding anatomic form. Anatomic form was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha 1: Continuous with existing anatomical form Alpha 2: Slightly discontinuous due to some chipping on the proximal ridge Bravo: Discontinuous with existing anatomical form due to material loss but proximal contact still present Charlie: Proximal contact is lost with ridge fracture. |
From baseline to 9 year the change of restorations was evaluated
|
color change
Time Frame: From baseline to 9 year the change of restorations was evaluated
|
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding color change. Colour changes was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: The restoration matches the adjacent tooth structure in color and translucency. Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency |
From baseline to 9 year the change of restorations was evaluated
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Gurgan S, Kutuk ZB, Ergin E, Oztas SS, Cakir FY. Four-year randomized clinical trial to evaluate the clinical performance of a glass ionomer restorative system. Oper Dent. 2015 Mar-Apr;40(2):134-43. doi: 10.2341/13-239-C. Epub 2014 Oct 9.
- Gurgan S, Kutuk ZB, Ergin E, Oztas SS, Cakir FY. Clinical performance of a glass ionomer restorative system: a 6-year evaluation. Clin Oral Investig. 2017 Sep;21(7):2335-2343. doi: 10.1007/s00784-016-2028-4. Epub 2016 Dec 20.
- Turkun LS, Kanik O. A Prospective Six-Year Clinical Study Evaluating Reinforced Glass Ionomer Cements with Resin Coating on Posterior Teeth: Quo Vadis? Oper Dent. 2016 Nov/Dec;41(6):587-598. doi: 10.2341/15-331-C. Epub 2016 Aug 29.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEK 09/112-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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