6-year Clinical Evaluation of Glass Ionomer Cements (GIS) With Resin Coating on Posterior Teeth (GIS)
2015년 11월 24일 업데이트: Sebnem Turkun, Ege University
A Prospective 6-year Clinical Study Evaluating Reinforced Glass Ionomer Cements With Resin Coating on Posterior Teeth
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).
연구 개요
상태
완전한
정황
상세 설명
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).
연구 유형
중재적
등록 (실제)
54
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
17년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
공부 계획
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디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: EquiaFil G-coat
EquiaFil G-coat combination was applied on one randomly selected cavity to be restored
|
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.
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.
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.
|
|
활성 비교기: EquiaFil Fuji Varnish
EquiaFil Fuji Varnish combination was applied on one randomly selected cavity to be restored
|
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.
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.
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.
|
|
활성 비교기: Riva SC G-coat
River SC G-coat combination was applied on one randomly selected cavity to be restored
|
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.
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.
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.
|
|
활성 비교기: Riva SC Fuji Varnish
River SC Fuji Varnish combination was applied on one randomly selected cavity to be restored
|
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.
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.
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Evaluating differently coated glass ionomer cements on posterior teeth with United State Public Health Service criteria regarding marginal adaptation by 2 independent evaluators
기간: 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
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6 years
|
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Evaluating differently coated glass ionomer cements on posterior teeth with United State Public Health Service criteria regarding marginal discolouration by 2 independent evaluators
기간: 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. |
6 years
|
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Evaluating differently coated glass ionomer cements on posterior teeth with United State Public Health Service criteria regarding retention rate by 2 independent evaluators
기간: 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
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6 years
|
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Evaluating differently coated glass ionomer cements on posterior teeth with United State Public Health Service criteria regarding anatomic form by 2 independent evaluators
기간: 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
|
6 years
|
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Evaluating differently coated glass ionomer cements on posterior teeth with United State Public Health Service criteria regarding colour changes by 2 independent evaluators
기간: 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. |
6 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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
기간: 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.
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6 years
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Ersin NK, Candan U, Aykut A, Oncag O, Eronat C, Kose T. A clinical evaluation of resin-based composite and glass ionomer cement restorations placed in primary teeth using the ART approach: results at 24 months. J Am Dent Assoc. 2006 Nov;137(11):1529-36. doi: 10.14219/jada.archive.2006.0087.
- 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.
- Sidhu SK. Glass-ionomer cement restorative materials: a sticky subject? Aust Dent J. 2011 Jun;56 Suppl 1:23-30. doi: 10.1111/j.1834-7819.2010.01293.x.
- Lohbauer U (2010) Dental glass ionomer cements as permanent filling materials? Properties, limitations and future trends. Materials 3(1) 76-96.
- Diem VT, Tyas MJ, Ngo HC, Phuong LH, Khanh ND. The effect of a nano-filled resin coating on the 3-year clinical performance of a conventional high-viscosity glass-ionomer cement. Clin Oral Investig. 2014 Apr;18(3):753-9. doi: 10.1007/s00784-013-1026-z. Epub 2013 Jul 7.
- Tyas MJ. Clinical evaluation of glass-ionomer cement restorations. J Appl Oral Sci. 2006;14 Suppl:10-3. doi: 10.1590/s1678-77572006000700003.
- Frankenberger R, Garcia-Godoy F, Kramer N. Clinical Performance of Viscous Glass Ionomer Cement in Posterior Cavities over Two Years. Int J Dent. 2009;2009:781462. doi: 10.1155/2009/781462. Epub 2010 Feb 22.
- Burke FJ, Siddons C, Cripps S, Bardha J, Crisp RJ, Dopheide B. Clinical performance of reinforced glass ionomer restorations placed in UK dental practices. Br Dent J. 2007 Jul 14;203(1):E2; discussion 40-1. doi: 10.1038/bdj.2007.529. Epub 2007 Jun 1. Erratum In: Br Dent J. 2007 Sep 22;203(6):369. Phipps, S [corrected to Cripps, S].
- Bonifacio CC, Werner A, Kleverlaan CJ. Coating glass-ionomer cements with a nanofilled resin. Acta Odontol Scand. 2012 Dec;70(6):471-7. doi: 10.3109/00016357.2011.639307. Epub 2011 Dec 12.
- Friedl K, Hiller KA, Friedl KH. Clinical performance of a new glass ionomer based restoration system: a retrospective cohort study. Dent Mater. 2011 Oct;27(10):1031-7. doi: 10.1016/j.dental.2011.07.004. Epub 2011 Aug 15.
- Basso M, Brambilla E, Benites MG, Giovannardi M & Ionescu AC (2015) Glass ionomer cement for permanent dental restorations: a 48-months, multi-center, prospective clinical trial Stomatology Education Journal 2(1) 25-35.
- Miletic I, Baraba A, Juic IB & Anic I (2013) Evaluation of a glass-ionomer based restoration system- a one year pilot study Journal of Minimum Intervention in Dentistry 6 87-95.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2009년 1월 1일
기본 완료 (실제)
2009년 9월 1일
연구 완료 (실제)
2015년 9월 1일
연구 등록 날짜
최초 제출
2015년 11월 20일
QC 기준을 충족하는 최초 제출
2015년 11월 24일
처음 게시됨 (추정)
2015년 11월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 11월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 11월 24일
마지막으로 확인됨
2015년 11월 1일
추가 정보
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