NCCL Direct Composite Restoration Performance With Self-Etch and Multimode Adhesives Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
研究概览
简要总结
The purpose is to evaluate/compare clinical effectiveness of dual cure (DC) all-in-one Self-Etch (Futurabond® DC (FBDC)) adhesive and multimode/universal (Futurabond® U (FU) and Adhese® Universal (AU)) adhesives, with or without selective enamel etching, in non-carious cervical lesions (NCCL), during 24th months, using Word Dental Federation (FDI) and United States Public Health Services (USPHS) criteria.
The null hypotheses are:
H0 - Bonding to NCCLs with DC-SE and SE-Universal adhesives with SE strategies will result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance in a period of 24th month evaluation; H0 - Bonding to NCCLs with DC-SE and SE-Universal adhesives with SE strategies will result in similar restorations (aesthetic, functional and biologic) success rates over 24th month evaluation; H0 - Bonding to NCCLs with DC-SE and SE-Universal adhesives with SE strategies will result in similar restoration retention rates in a period of 24th month evaluation; H0 - Bonding to NCCLs DC-SE with enamel pre-etching and Universal adhesives with ER adhesive strategy will result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance in a period of 24thmonth evaluation; H0 - Bonding to NCCLs DC-SE with enamel pre-etching and Universal adhesives with ER adhesive strategy will result in similar restorations (aesthetic, functional and biologic) success rates over 24th month evaluation; H0 - Bonding to NCCLs DC-SE with enamel pre-etching and Universal adhesives with ER adhesive strategy will result in similar restoration retention rates in a period of 24th month evaluation; H0 - Bonding to NCCLs with FBDC or FU (DC adhesives) and AU (Light-curing adhesive) with SE or ER adhesive strategies will result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance in a period of 24th month evaluation; H0 - Bonding to NCCLs with FBDC or FU (DC adhesives) and AU (Light-curing adhesive) with SE or ER adhesive strategies will result in similar restorations (aesthetic, functional and biologic) success rates over 24th month evaluation; H0 - Bonding to NCCLs with FBDC or FU (DC adhesives) and AU (Light-curing adhesive) with SE or ER adhesive strategies will result in similar restoration retention rates in a period of 24th month evaluation; H0 - FDI or USPHS criteria evaluation outcomes not differ for the same data.
详细描述
2.1- DESIGN The trial design will follow the Consolidated Standards of Reporting Trials (CONSORT) statement (1, 2).
Prospective, double blind clinical trial; randomized allocation of NCCL restorations by six adhesion treatment groups (6 arms: G1 to G6) for examination of restorations performance. Study will take place in University Fernando Pessoa - Faculty of Health Sciences (UFP-FHS), Dental Medicine School Clinic. Participants recruitment estimated between November 2015 and April 2016.
The study is scheduled to last 24th months. Baseline clinical observation will be done 30 days after placement of adhesion restoration (First data), second observation at 12 months and last evaluation at 24 months (Data for Statistical analysis). Clinical trial may continue for similar assessment intervals, after 24th months evaluation. This situation requires new analysis according to clinical and economics conditions, at that time.
2.2- POPULATION AND PARTICIPANT SELECTION
All participants will be informed (Written and verbal information) about the trial conditions and purposes, but will not be aware of what tooth will received the adhesion treatment. Written informed consent, according to World Medical Association Declaration of Helsinki (3), will be obtained from all participants prior to starting the treatment. University Fernando Pessoa Ethics Committee review and approved the present protocol. This clinical trial is done according to the National Law 21/2014, of 16 April, and was analysed, approved and authorized by the National Competent Authorities:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders
- •ages up to 18 years old and less than 65 years old
- •Patients with diagnosis and treatment required of dental structure loss in cervical vestibular surfaces with non-bacterial or chemical origin, which is non-carious cervical lesions (NCCL) in premolar/molar teeth (These lesions have to be non-carious, non-retentive, deeper than 1 mm, and involve both the enamel and dentin of vital teeth without mobility. The cavo-surface margin cannot involve more that 50% of enamel.)
排除标准
- •Patients with a number of teeth inferior than 20 in occlusion;
- •If the tooth is not vital;
- •Chronic periodontal disease;
- •Incapacity to return to follow-up;
- •To participate in another clinical evaluation in course at that time;
- •Medical, psychiatric history or pharmacotherapy to compromise the protocol
- •Pregnancy;
- •Allergies and idiosyncratic answers to the ingredients of the products;
- •Fixed orthodontic treatment;
- •Teeth support for fixed prosthodontic treatments;
- •Teeth or structures of support with pulpa injury in transition phase;
- •Periodontal surgery in the 3 previous months;
- •Severe bruxism;
- •Extremely poor oral hygiene;
- •Patient refuse to voluntary participate in the trial.
结局指标
主要结局
Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
时间窗: 24 months
Clinical Performance Acceptance was expressed as the number of NCCls restorations scored as "1-Clinically excellent/ very good", "2-Clinically good (after correction, very good)", "3-Clinically sufficient/ satisfactory (minor shortcomings with no adverse effects but not adjustable without damage to the tooth)", "4-Clinically unsatisfactory (repair for prophylactic reasons)". NCCls restorations with not acceptable performance were scored as "5-Clinically poor (replacement necessary)" for clinical properties. NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.
Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 4-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
时间窗: 24 months
Clinical Performance Acceptance was expressed as the number of NCCls restorations scored as "Alfa" and "Bravo". NCCls restorations with not acceptable performance were scored as "Charlie" for Esthetic properties, for Retention criteria and for Biological properties, and also scored "Delta" for Marginal Adaptation criteria. NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.
FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.
时间窗: 24 months
FDI or USPHS criteria evaluation outcomes for Esthetic, Functional and Biological parameters, at 24th month follow-up were expressed as the number os NCCLs With Clinical Acceptance for each parameter. NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.
次要结局
- Postoperative Hypersensibility, Tooth Vitality, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall(24 months)
- Retention, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall(24 months)
- Staining Margin, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall(24 months)
- Tooth Integrity (Enamel Cracks), Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall(24 months)
- Colour Stability and Translucency, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall(24 months)
- Fractures and Retention, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall(24 months)
- Marginal Adaptation, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall(24 months)
- Marginal Discoloration, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall(24 months)
- Secondary Caries, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall(24 months)
- Gingival Bleeding, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall(24 months)
- Surface Luster, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall(24 months)
- Recurrence of Caries, Erosion, Abfraction, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall(24 months)
- Surface Staining, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall(24 months)
- Color Match, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall(24 months)
- Marginal Integrity, Graded on a 4-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall(24 months)
- Postoperative Sensitivity, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall(24 months)
研究者
Patrícia Manarte Monteiro
Associate Professor
University Fernando Pessoa