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Background <p>The objective of this randomized clinical trial was to evaluate the clinical performance of restorative material extra low shrinkage (ELS) versus advanced polymer technology (APT) based resin composite for Class I and Class II preparations in permanent teeth.</p> Methods <p>Between 12.12.2017–26.10.2018, 30 patients aged between 18 and 44 years old (22 females, 8 males, mean age: 25,2) received randomly 30 pairs of restorations restored using either ELS (Saremco, Switzerland) or APT composite (Saremco, Switzerland) in Class I and Class II cavities. Two operators performed all restorations using ELS and APT resin composites according to manufacturer’s instructions. Two independent calibrated operators evaluated the restorations 2 weeks after placement (baseline), at 6 months, 1 year, 2 and 3 years using FDI criteria (Scores 1–5) for surface staining, marginal staining, marginal gap, marginal fracture, marginal irregularities, secondary caries, marginal tooth integrity, surface luster, color match and translucency, fracture of material and retention, occlusal wear, approximal contact point, patient view, tooth integrity and post operative sensitivity.</p> Results <p>Sixty restorations were placed of which 37 (ELS: 18, APT:19) were in the maxilla and 23 (ELS: 12, APT:11) in the mandible. From the occluso-cervical (OC) perspective, the dimension of the preparations ranged between 5&#xa0;mm and 2.7&#xa0;mm and from buccolingual (BL) dimension between 4&#xa0;mm and 2&#xa0;mm. 32 (53.3%) restorations completed their 2-year follow up, 50 restorations (83.3%) completed their 3 years. In the 2-year follow ups 1 endodontic complication was recorded in the APT group. With the 3 year results a total of 4 failures (2 restorations at 1 year, 2 restorations at 2 year) were recorded up to now. Both resin composite restorations were clinically acceptable.</p> Conclusions <p>This study provided promising evidence for application of ELS and APT materials applied in Class I and II cavities.</p> Trial registration <p>The study was registered at clinicaltrials.gov with registration No. NCT03306576 at 2017-10-11 and approved by İstanbul Medipol University Ethics Committee with protocol No:10840098-604.01.01-E.21,426 in accordance with the Decleration of Helsinki.</p>

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Clinical evaluation of restorations made of ELS extra low shrinkage versus APT advanced polymer technology resin composite: a prospective randomized controlled clinical trial up to 3 years

  • 期刊论文

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  • 发表日期：

    2025年12月29日

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  • Alev Özsoy-Kaner,
  • Mahmut Kuşdemir,
  • Funda Öztürk-Bozkurt,
  • Tugba Toz-Akalin,
  • Mutlu Özcan

摘要

Background

The objective of this randomized clinical trial was to evaluate the clinical performance of restorative material extra low shrinkage (ELS) versus advanced polymer technology (APT) based resin composite for Class I and Class II preparations in permanent teeth.

Methods

Between 12.12.2017–26.10.2018, 30 patients aged between 18 and 44 years old (22 females, 8 males, mean age: 25,2) received randomly 30 pairs of restorations restored using either ELS (Saremco, Switzerland) or APT composite (Saremco, Switzerland) in Class I and Class II cavities. Two operators performed all restorations using ELS and APT resin composites according to manufacturer’s instructions. Two independent calibrated operators evaluated the restorations 2 weeks after placement (baseline), at 6 months, 1 year, 2 and 3 years using FDI criteria (Scores 1–5) for surface staining, marginal staining, marginal gap, marginal fracture, marginal irregularities, secondary caries, marginal tooth integrity, surface luster, color match and translucency, fracture of material and retention, occlusal wear, approximal contact point, patient view, tooth integrity and post operative sensitivity.

Results

Sixty restorations were placed of which 37 (ELS: 18, APT:19) were in the maxilla and 23 (ELS: 12, APT:11) in the mandible. From the occluso-cervical (OC) perspective, the dimension of the preparations ranged between 5 mm and 2.7 mm and from buccolingual (BL) dimension between 4 mm and 2 mm. 32 (53.3%) restorations completed their 2-year follow up, 50 restorations (83.3%) completed their 3 years. In the 2-year follow ups 1 endodontic complication was recorded in the APT group. With the 3 year results a total of 4 failures (2 restorations at 1 year, 2 restorations at 2 year) were recorded up to now. Both resin composite restorations were clinically acceptable.

Conclusions

This study provided promising evidence for application of ELS and APT materials applied in Class I and II cavities.

Trial registration

The study was registered at clinicaltrials.gov with registration No. NCT03306576 at 2017-10-11 and approved by İstanbul Medipol University Ethics Committee with protocol No:10840098-604.01.01-E.21,426 in accordance with the Decleration of Helsinki.