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

Ege University

Status: Completed

Conditions: Dental Caries

Treatments: Other: EquiaFil G-coat; Other: EquiaFil Fuji Varnish; Other: Riva SC Fuji Varnish; Other: Riva SC G-coat

Study type: Interventional

Funder types: Other

Identifiers

NCT02616198

08-10.1/6

Details and patient eligibility

About

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).

Full 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).

Enrollment: 54 patients

Sex: All

Ages: 17 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. having good oral hygiene;
2. need for at least two or more posterior restorations in contact with neighbouring tooth and in occlusion with antagonist teeth;
3. teeth planned to be restore should be vital and symptomless;
4. the cavity isthmus size should be more than 1/3 of the intercuspal distance.

Exclusion criteria

1. absence of adjacent and antagonist teeth;
2. teeth with periodontal problems;
3. teeth with preoperative pain or pulpal inflammations;
4. teeth formerly subjected to direct pulp capping;
5. patients having severe systemic diseases, allergies or adverse medical history.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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54 participants in 4 patient groups

EquiaFil G-coat

Active Comparator group

Description:

EquiaFil G-coat combination was applied on one randomly selected cavity to be restored

Treatment:

Other: EquiaFil Fuji Varnish

Other: Riva SC Fuji Varnish

Other: Riva SC G-coat

EquiaFil Fuji Varnish

Active Comparator group

Description:

EquiaFil Fuji Varnish combination was applied on one randomly selected cavity to be restored

Treatment:

Other: Riva SC Fuji Varnish

Other: Riva SC G-coat

Other: EquiaFil G-coat

Riva SC G-coat

Active Comparator group

Description:

River SC G-coat combination was applied on one randomly selected cavity to be restored

Treatment:

Other: EquiaFil Fuji Varnish

Other: Riva SC Fuji Varnish

Other: EquiaFil G-coat

Riva SC Fuji Varnish

Active Comparator group

Description:

River SC Fuji Varnish combination was applied on one randomly selected cavity to be restored

Treatment:

Other: EquiaFil Fuji Varnish

Other: Riva SC G-coat

Other: EquiaFil G-coat