6-year Clinical Evaluation of Glass Ionomer Cements (GIS) With Resin Coating on Posterior Teeth
- Conditions
- Dental Caries
- Interventions
- Other: EquiaFil Fuji VarnishOther: EquiaFil G-coatOther: Riva SC G-coatOther: Riva SC Fuji Varnish
- Registration Number
- NCT02616198
- Lead Sponsor
- Ege University
- Brief Summary
The aim of this study was to evaluate the long-term clinical performance of two highly viscous encapsulated GICs (EquiaFil and Riva SC) covered with two different coatings (Equia Coat and Fuji Varnish) over 6-year using modified United State Public Health Service (USPHS) criteria.
A total of 256 restorations were made with EquiaFil and Riva SC. Equia Coat or Fuji Varnish was used randomly on the surface of the restorations. The restorations were evaluated at baseline, 6, 12, 18 months and 6 years after placement using modified USPHS criteria. The results were evaluated with Pearson Chi-Square and Mann Whitney U-test (p\< 0.05).
- Detailed Description
The aim of this study was to evaluate the long-term clinical performance of two highly viscous encapsulated GICs (EquiaFil and Riva SC) covered with two different coatings (Equia Coat and Fuji Varnish) over 6-year using modified United State Public Health Service (USPHS) criteria.
Fifty-four patients having Class I and II restorations/caries were included in the study. A total of 256 restorations were made with EquiaFil (GC Corp, Japan) and Riva SC (SDI, Australia). Equia Coat or Fuji Varnish was used randomly on the surface of the restorations. After cavity preparations, the teeth were randomly restored with one glass ionomer cement and coated with Equia Coat or Fuji Varnish. The restorations were evaluated at baseline, 6, 12, 18 months and 6 years after placement using modified USPHS criteria. Two evaluators checked color-match, marginal discoloration, marginal adaptation, caries formation, anatomical form, postoperative sensitivity and retention rate and photographs were taken at each recalls. The results were evaluated with Pearson Chi-Square and Mann Whitney U-test (p\< 0.05).
The 18-month results were presented at the CED IADR congress iheld in Barcelona in 2010 (Turkun LS, \& Kanic O ,Clinical evaluation of new glass ionomer coating combined systems for 18-months Journal of Dental Research 89 (Special Issue B) Abstract #402.) Gurgan S et al. also mentioned our 18-month results in their published manuscript ( Gurgan S,Kutuk ZB, Ergin E, Oztas ZZ \& Cakir FY (2015) Four-year randomized clinical trial to evaluate the clinical performance of a glass ionomer restorative system Operative Dentistry 40(2) 134-143).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- having good oral hygiene;
- need for at least two or more posterior restorations in contact with neighbouring tooth and in occlusion with antagonist teeth;
- teeth planned to be restore should be vital and symptomless;
- the cavity isthmus size should be more than 1/3 of the intercuspal distance.
- absence of adjacent and antagonist teeth;
- teeth with periodontal problems;
- teeth with preoperative pain or pulpal inflammations;
- teeth formerly subjected to direct pulp capping;
- patients having severe systemic diseases, allergies or adverse medical history.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description EquiaFil G-coat EquiaFil Fuji Varnish EquiaFil G-coat combination was applied on one randomly selected cavity to be restored EquiaFil G-coat Riva SC G-coat EquiaFil G-coat combination was applied on one randomly selected cavity to be restored Riva SC G-coat Riva SC Fuji Varnish River SC G-coat combination was applied on one randomly selected cavity to be restored Riva SC Fuji Varnish Riva SC G-coat River SC Fuji Varnish combination was applied on one randomly selected cavity to be restored EquiaFil Fuji Varnish Riva SC G-coat EquiaFil Fuji Varnish combination was applied on one randomly selected cavity to be restored EquiaFil G-coat Riva SC Fuji Varnish EquiaFil G-coat combination was applied on one randomly selected cavity to be restored EquiaFil Fuji Varnish Riva SC Fuji Varnish EquiaFil Fuji Varnish combination was applied on one randomly selected cavity to be restored Riva SC G-coat EquiaFil G-coat River SC G-coat combination was applied on one randomly selected cavity to be restored Riva SC G-coat EquiaFil Fuji Varnish River SC G-coat combination was applied on one randomly selected cavity to be restored Riva SC Fuji Varnish EquiaFil Fuji Varnish River SC Fuji Varnish combination was applied on one randomly selected cavity to be restored EquiaFil Fuji Varnish EquiaFil G-coat EquiaFil Fuji Varnish combination was applied on one randomly selected cavity to be restored Riva SC Fuji Varnish EquiaFil G-coat River SC Fuji Varnish combination was applied on one randomly selected cavity to be restored
- Primary Outcome Measures
Name Time Method Evaluating differently coated glass ionomer cements on posterior teeth with United State Public Health Service criteria regarding marginal adaptation by 2 independent evaluators 6 years 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
Evaluating differently coated glass ionomer cements on posterior teeth with United State Public Health Service criteria regarding marginal discolouration by 2 independent evaluators 6 years 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.Evaluating differently coated glass ionomer cements on posterior teeth with United State Public Health Service criteria regarding retention rate by 2 independent evaluators 6 years 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
Evaluating differently coated glass ionomer cements on posterior teeth with United State Public Health Service criteria regarding anatomic form by 2 independent evaluators 6 years 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
Evaluating differently coated glass ionomer cements on posterior teeth with United State Public Health Service criteria regarding colour changes by 2 independent evaluators 6 years 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.
- Secondary Outcome Measures
Name Time Method Effects of resin coating on the performance of glass ionomer cements according to the United State Public Health Service criteria regarding marginal adaptation, marginal discolouration, retention rate, and colour changes by 2 independent evaluators 6 years The effect of different coatings on the clinical performance of the different glass ionomers tested was evaluated with United State Public Health Service criteria at baseline, 6-12-18 months and 6-years. For the evaluation 2 independent evaluators using dental problem and mirrors evaluated the resin coatings according to their retention, marginal adaptation, marginal discolouration, and colour match. There were 4 evaluation scores. Alpha meaning a perfect resin coating, Bravo meaning a coating partially effective but still clinically acceptable and Charlie and Delta meaning that the coating was partially to totally missed.