Evaluation of the Effects of Retraction Cord Placed in the Gingival Sulcus on Periodontal Tissues in Restorative Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Split-Mouth Gingival Index Difference (ΔGI) Over Time
研究概览
简要总结
The goal of this clinical trial is to learn whether a retraction cord affects gum health when used during tooth restoration procedures. A retraction cord is a thin thread that dentists sometimes place between the tooth and the gum surrounding it, to gently push the gum aside so the restoration can be performed in a clean surface isolated from saliva.
The study includes adult teeth with tooth damage near the gumline that has not been caused by decay, yet needs a restoration. The main research question is: Does using a retraction cord make a difference for gum health as opposed to not using one? Participants will be assigned into four separate groups. Two groups will receive a restoration with one type of bonding material, either with or without a retraction cord. The other two groups will receive a restoration with a different kind of bonding material, either with or without a retraction cord.
Researchers will check gum health status before the restorations and again on days 1, 7, and 28. They will observe symptoms such as swelling in the gums, bleeding of the gums, and gum margin positions. A fluid sample from the area between the gum and tooth will be collected to test for molecules of inflammation.
详细描述
Study Rationale Retraction cord is commonly used during composite resin restoration of non-carious cervical lesions to control gingival crevicular fluid and improve visibility. Its effect on periodontal health in this specific application has not been well characterized. This study compares clinical periodontal parameters and gingival crevicular fluid (GCF) biomarker levels with and without cord placement.
Study Design This is a randomized, tooth-level (split-mouth), double-blind clinical trial following a 2×2 factorial design: adhesive system (G-Premio Bond vs. 3M Scotchbond Universal Plus) × retraction cord use (with vs. without). Eligible participants had multiple qualifying lesions, allowing individual teeth to be randomly allocated by coin-flip to different groups within the same participant. The participants and the examiner performing periodontal measurements were blinded to group allocation.
Procedures All restorations were placed by a single operator. In cord groups, an Ultrapak retraction cord was placed in the gingival sulcus before adhesive application and left in situ throughout the restorative procedure. Clinical periodontal parameters (Plaque Index, Gingival Index, Bleeding on Probing, Probing Pocket Depth, Keratinized Tissue Width, relative gingival margin position) and GCF samples were collected at baseline and on days 1, 7, and 28 after restoration. GCF biomarkers (TNF-α, IL-8, MMP-8, TIMP-1, PGE-2, LXA-4) were quantified using enzyme-linked immunosorbent assay (ELISA).
Enrollment Twelve participants (69 teeth) were initially enrolled; the study was completed with 10 participants (57 teeth) following two withdrawals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Systemically healthy
- •Non-smoker
- •Periodontally healthy (whole-mouth bleeding on probing <10%, mean probing pocket depth ≤3 mm, mean Plaque Index and Gingival Index ≤1.1)
- •At least 20 teeth in occlusion (full/near-full dentition)
- •At least 4 non-carious cervical lesions, each ≥1 mm in depth, involving both enamel and dentin, with vital pulp status
排除标准
- •Presence of systemic disease
- •Use of medication known to affect inflammatory response during the study period
- •Inability or unwillingness to comply with follow-up visits
- •Pregnancy or lactation
- •Current smoking
- •Presence of periodontal disease
研究组 & 干预措施
Group 2: G-Premio Bond + Retraction Cord
Composite resin restoration using 3M Filtek Easy Match Universal Restorative with 3M Scotchbond Universal Plus adhesive, without retraction cord placement.
干预措施: Composite Resin Restorative (Device)
Group 2: G-Premio Bond + Retraction Cord
Composite resin restoration using 3M Filtek Easy Match Universal Restorative with 3M Scotchbond Universal Plus adhesive, without retraction cord placement.
干预措施: Universal Adhesive - G-Premio Bond (Device)
Group 3: Scotchbond Universal Plus, No Cord
Composite resin restoration using 3M Filtek Easy Match Universal Restorative with 3M Scotchbond Universal Plus adhesive, without retraction cord placement.
干预措施: Composite Resin Restorative (Device)
Group 1: G-Premio Bond, No Cord
Composite resin restoration of non-carious cervical lesions using 3M Filtek Easy Match Universal Restorative with G-Premio Bond adhesive, without retraction cord placement.
干预措施: Universal Adhesive - G-Premio Bond (Device)
Group 2: G-Premio Bond + Retraction Cord
Composite resin restoration using 3M Filtek Easy Match Universal Restorative with 3M Scotchbond Universal Plus adhesive, without retraction cord placement.
干预措施: Gingival Retraction Cord (Device)
Group 3: Scotchbond Universal Plus, No Cord
Composite resin restoration using 3M Filtek Easy Match Universal Restorative with 3M Scotchbond Universal Plus adhesive, without retraction cord placement.
干预措施: Universal Adhesive - Scotchbond Universal Plus (Device)
Group 4: Scotchbond Universal Plus + Retraction Cord
Composite resin restoration using 3M Filtek Easy Match Universal Restorative with 3M Scotchbond Universal Plus adhesive, with Ultrapak retraction cord placed in the gingival sulcus before restoration.
干预措施: Gingival Retraction Cord (Device)
Group 4: Scotchbond Universal Plus + Retraction Cord
Composite resin restoration using 3M Filtek Easy Match Universal Restorative with 3M Scotchbond Universal Plus adhesive, with Ultrapak retraction cord placed in the gingival sulcus before restoration.
干预措施: Composite Resin Restorative (Device)
Group 4: Scotchbond Universal Plus + Retraction Cord
Composite resin restoration using 3M Filtek Easy Match Universal Restorative with 3M Scotchbond Universal Plus adhesive, with Ultrapak retraction cord placed in the gingival sulcus before restoration.
干预措施: Universal Adhesive - Scotchbond Universal Plus (Device)
Group 1: G-Premio Bond, No Cord
Composite resin restoration of non-carious cervical lesions using 3M Filtek Easy Match Universal Restorative with G-Premio Bond adhesive, without retraction cord placement.
干预措施: Composite Resin Restorative (Device)
结局指标
主要结局
Change in Split-Mouth Gingival Index Difference (ΔGI) Over Time
时间窗: Baseline, and Days 1, 7, and 28 after restoration
Difference in Gingival Index (Löe \& Silness) between cord-treated and no-cord teeth within the same participant (split-mouth design), assessed at each time point. The Gingival Index (Löe \& Silness) ranges from 0 to 3, where 0 indicates healthy gingiva and 3 indicates severe inflammation; higher scores indicate a worse outcome.
次要结局
- Change in Bleeding on Probing (BOP)(Baseline, and Days 1, 7, and 28 after restoration)
- Change in Probing Pocket Depth (PPD)(Baseline, and Days 1, 7, and 28 after restoration)
- Change in Keratinized Tissue Width (KTW)(Baseline, and Days 1, 7, and 28 after restoration)
- Change in Relative Gingival Margin Position(Baseline, and Days 1, 7, and 28 after restoration)
- Change in Gingival Crevicular Fluid Tumor Necrosis Factor-alpha (TNF-α) Concentration(Baseline (before restoration), and Days 1, 7, and 28 after restoration)
- Change in Gingival Crevicular Fluid Interleukin-8 (IL-8) Concentration(Baseline, and Days 1, 7, and 28 after restoration)
- Change in Gingival Crevicular Fluid Matrix Metalloproteinase-8 (MMP-8) Concentration(Baseline, and Days 1, 7, and 28 after restoration)
- Change in Gingival Crevicular Fluid Tissue Inhibitor of Metalloproteinase-1 (TIMP-1) Concentration(Baseline, and Days 1, 7, and 28 after restoration)
- Change in Gingival Crevicular Fluid Prostaglandin E2 (PGE-2) Concentration(Baseline, and Days 1, 7, and 28 after restoration)
- Change in Gingival Crevicular Fluid Lipoxin A4 (LXA-4) Concentration(Baseline, and Days 1, 7, and 28 after restoration)
- Change in Plaque Index (PI)(Baseline, and Days 1, 7, and 28 after restoration)
研究者
Ali Çekici
Professor
Istanbul University