NCT02616198

6-year Clinical Evaluation of Glass Ionomer Cements (GIS) With Resin Coating on Posterior Teeth

A Prospective 6-year Clinical Study Evaluating Reinforced Glass Ionomer Cements With Resin Coating on Posterior Teeth

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Ege University · Academic / Other
• Sex: All
• Age: 17 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Dental Caries

Interventions

Type	Name	Description
OTHER	EquiaFil G-coat	The old restorations or new caries were removed with anaesthetic solutions when necessary, a matrix was applied for two surface cavities and the restoration was performed with EquiaFil in bulk after mixing 10 sec. in the mixing machine. After 2min 30 sec, the restoration was contoured and the occlusion adjusted.Then the surface was coated with G-coat and light cured for 10 sec. The restorations were controlled by 2 independent examiners at baseline, 6-12-18 months and 6 years according to the United State Public Health Service criteria.
OTHER	EquiaFil Fuji Varnish	The old restorations or carious lesions were removed with anaesthetic solutions when necessary, a matrix was applied for two surface cavities and the restoration was performed with EquiaFil in bulk after mixing in the mixing machine. After 2min 30 sec, the restoration was contoured and the occlusion adjusted.Then the surface was coated in 2 layers of Fuji Varnish. The restorations were controlled by 2 independent examiners at baseline, 6-12-18 months and 6 years according to the United State Public Health Service criteria.
OTHER	Riva SC G-coat	The old restorations or carious lesions were removed and a sectional matrix was applied for two surface cavities and the restoration was performed with Riva SC in bulk after mixing 10 sec. in the mixing machine. The glass ionomer was packed with hand instruments in the cavities and 2min after the first setting the restoration was contoured and the occlusion adjusted.Then the surface was coated with G-coat resin and light cured for 10 sec. The restorations were controlled by 2 independent examiners at baseline, 6-12-18 months and 6 years according to the United State Public Health Service criteria.
OTHER	Riva SC Fuji Varnish	The caries lesions were removed with diamond and stainless steel burs, a sectional matrix was applied for restoring two surface cavities and the restoration was performed with Riva SC in bulk after mixing 10 sec. in the mixing machine. After the first setting of 2min, the restoration was contoured and the occlusion adjusted.Then the surface was coated in 2 layers with Fuji Varnish. The restorations were controlled by 2 independent examiners at baseline, 6-12-18 months and 6 years according to the United State Public Health Service criteria.

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-09-01
• Completion: 2015-09-01
• First posted: 2015-11-26
• Last updated: 2015-11-26