Composite Resins Reconditioned, Behavior and Survival: Clinical Follow-up 10 Years (reacondcomp)
調査の概要
状態
条件
詳細な説明
A cohort of 26 patients aged 18-80 years old (mean: 28.35 years; 42% men, 58% women) with 78 composite restorations (Class I: 39; Class II: 39) were recruited at the Operative Dentistry Clinic at the Dental School of the University of Chile. All participants in the refurbishing groups showed clinical features for the anantomy, roughness and/or luster that deviated from the ideal and were rated Bravo according to the modified United States Public Health Service (USPHS) criteria. New Composites with Alpha values (Replacement group) and acceptable composites (No treatment group) were used as controls. The protocol was approved by the Institutional Research Ethics Committee of the Dental School at the University of Chile (Project PRI-ODO-0207). All patients signed informed-consent forms and completed registration forms
General Inclusion Criteria:
- Patients with more than 20 teeth.
- Restorations in functional occlusion, with an opposing natural tooth.
- Asymptomatic restored tooth.
- At least one proximal contact area with a neighboring tooth.
- Patients older than 18 years.
- Patients who agreed and signed a consent form for participating in the study.
- Area outside of the restoration failure is in good condition.
General Exclusion Criteria:
- Patients with contra-indications for regular dental treatment based on their medical history.
- Patients with xerostomia or individuals taking medication that significantly decreased salivary flow.
- Patients with a high risk of caries.
- Patients with psychiatric or physical diseases, which interfered with oral hygiene.
Treatment Group Criteria Two hundred four patients were initially evaluated and assigned in accordance with the modified USPHS criteria,26 patients were selected based on the inclusion criteria with at least 1 Composite restoration with anatomy, roughness and/or luster (Bravo) suitable for reburbishing, with another composite restorations that had excellent values (Alpha) and was made at this time (Replacement group).And finally another composite pre-existing with acceptable condition (Alpha or Bravo values) acted as control. The patient was considered the statistical unit in this study (n=20).
Restoration Assessment The quality of the restorations was scored in accordance with the modified USPHS criteria. The Cohen Kappa inter-examiner coefficient was 0.74 in the first year and 0.87 after 10 years for two examiners (JM and EF) who underwent calibration training exercises each year. In the first, second, third, fourth, fifth, and tenth years, the examiners independently assessed the restorations for anatomic form, roughness, color, marginal staining,luster, secondary caries, marginal and marginal adaptation, both directly via tactile and visual examinations with mouth mirror number five and explorer number 23 (Hu Friedy Mfg. Co. Inc.) and indirectly by radiographic examination (bite wing). A third clinician (GM), who also underwent the calibration training exercises, made the final decision if a difference was recorded between the two examiners and they could not reach an agreement.
Treatment Groups Refurbishing For this group, The dentists finished the occlusal, lingual or facial surfaces of defective RBC restorations with the medium series of aluminum oxide disks (Sof-Lex,3M ESPE) or carbide burs (12 and 30 blades,Brasseler USA, Dental Instrumentation,Savannah, Ga.) and then polished them with afine series of aluminum oxide disks (Sof-Lex, 3M ESPE) and diamond-impregnated composite polisher (ComposiPro Diacomp, Brasseler). For restorations in which proximal surface areas were affected, the clinicians smoothed them with interproximal aluminum oxide finishing strips (Sof-Lex Finishing Strips, 3M ESPE).
Replacement group Composite resins with Alpha values for the marginal adaptation criteria were used as the positive control and were made with resin composite (Filtek Supreme, 3M ESPE), eith rubber dam isolation and the adhesive system L-Pop Prompt (3M-ESPE) No treatment Composite resin restorations (Z100, 3M ESPE) in general clinically acceptable, did not receive treatment.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Santiago、チリ、7500505
- Eduardo Fernandez Godoy
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients with more than 20 teeth.
- Restorations in functional occlusion, with an opposing natural tooth.
- Asymptomatic restored tooth.
- At least one proximal contact area with a neighboring tooth.
- Patients older than 18 years.
- Patients who agreed and signed a consent form for participating in the study.
- Area outside of the restoration failure is in good condition.
Exclusion Criteria:
- Patients with contra-indications for regular dental treatment based on their medical history.
- Patients with xerostomia or individuals taking medication that significantly decreased salivary flow.
- Patients with a high risk of caries.
- Patients with psychiatric or physical diseases, which interfered with oral hygiene.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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Replacement
Composite resins with Alpha values for the marginal adaptation criteria were used as the positive control and were made with resin composite (Filtek Supreme, 3M ESPE), eith rubber dam isolation and the adhesive system L-Pop Prompt (3M-ESPE)
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No treatment
Composite resin restorations (Z100, 3M ESPE) in general clinically acceptable, did not receive treatment.
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Refurbishing
For this group, The dentists finished the occlusal, lingual or facial surfaces of defective RBC restorations with the medium series of aluminum oxide disks (Sof-Lex,3M ESPE) or carbide burs (12 and 30 blades,Brasseler USA, Dental Instrumentation,Savannah, Ga.) and then polished them with afine series of aluminum oxide disks (Sof-Lex, 3M ESPE) and diamond-impregnated composite polisher (ComposiPro Diacomp, Brasseler).
For restorations in which proximal surface areas were affected, the clinicians smoothed them with interproximal aluminum oxide finishing strips (Sof-Lex Finishing Strips, 3M ESPE).
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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修復物の品質の変化
時間枠:1年
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修復物の品質は、修正された USPHS 基準に従って採点されました。
毎年 2 人の試験官 (JM と EF) が校正演習を受けました。
治療直後 (ベースライン) と 10 年後、検査者はマウスミラー番号 5 とエクスプローラー番号 23 (Hu Friedy Mfg.
Co. Inc.、シカゴ、イリノイ州、米国)および間接的に X 線検査(咬合翼)によって行われます。
検査された 4 つのパラメータは、解剖学的形態、二次カリエス、辺縁染色および辺縁適応でした。
2 人の検査官の間で差異が記録され、合意に達しなかった場合は、同じくキャリブレーション演習を受けた 3 人目の臨床医 (GM) が最終決定を下しました。
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1年
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協力者と研究者
スポンサー
捜査官
- 主任研究者:eduardo fernandez、University of Chile
出版物と役立つリンク
一般刊行物
- Moncada G, Vildosola P, Fernandez E, Estay J, de Oliveira Junior OB, de Andrade MF, Martin J, Mjor IA, Gordan VV. Longitudinal results of a 10-year clinical trial of repair of amalgam restorations. Oper Dent. 2015 Jan-Feb;40(1):34-43. doi: 10.2341/14-045-C. Epub 2014 Aug 6.
- Fernandez E, Martin J, Vildosola P, Oliveira Junior OB, Gordan V, Mjor I, Bersezio C, Estay J, de Andrade MF, Moncada G. Can repair increase the longevity of composite resins? Results of a 10-year clinical trial. J Dent. 2015 Feb;43(2):279-86. doi: 10.1016/j.jdent.2014.05.015. Epub 2014 Jun 4.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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