Dental Caries Class II Clinical Trial
Official title:
Randomized, Controlled Trial of Glass Ionomer System vs Composite Posterior Restorations in Extended Sized Class 2 Cavities
Verified date | December 2016 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ethics Committee |
Study type | Interventional |
The aim of this clinical trial was to compare the clinical performances of a glass ionomer restorative system with a micro hybrid resin based composite in extended sized class II cavities. A total of 100 class 2 lesions were restored with a glass ionomer restorative system (Equia Forte) or a micro hybrid composite (G-aenial Posterior). Restorations were evaluated at baseline and yearly during 6 years according to the modified-USPHS criteria. Data were analyzed with Cohcran's Q and McNemar's tests (p<0.05).
Status | Enrolling by invitation |
Enrollment | 50 |
Est. completion date | December 2021 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 20 Years to 50 Years |
Eligibility |
Inclusion Criteria: 1. a need for at least two but not more than four posterior toothcolored restorations; 2. the presence of teeth to be restored in occlusion; 3. teeth that were symptomless and vital; 4. a normal periodontal status; 5. a good likelihood of recall availability. Exclusion Criteria: 1. partly erupted teeth; 2. absence of adjacent and antagonist teeth 3. poor periodontal status; 4. adverse medical history; 5. potential behavioral problems. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Turkey | Hacettepe University School of Dentistry | Ankara |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) Bravo: Marginal gap (> 100µ) with discoloration (unremovable) Charlie: The restoration is fractured or missed. | From baseline to 6 year the change of restorations was evaluated | Yes |
Primary | 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 6 year the change of restorations was evaluated | Yes |
Primary | 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 6 year the change of restorations was evaluated | Yes |
Primary | 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 6 year the change of restorations was evaluated | Yes |
Primary | 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 failedand 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 6 year the change of restorations was evaluated | Yes |
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