Effect of Mechanical Polishing and 35% Hydrogen Peroxide Application on DIAGNOdent Measurements in Stained Occlusal Fissures: A Randomized Split-Mouth Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in DIAGNOdent Score
研究概览
简要总结
This study compared two methods of cleaning stained pits and grooves (fissures) on the chewing surfaces of back teeth before measuring them with a laser fluorescence device (DIAGNOdent), which is used to help detect early tooth decay. In the same patients, one side of the mouth was treated with mechanical polishing using a prophylaxis paste, while the other side was treated with a 35% hydrogen peroxide gel. The study measured whether either cleaning method changed the device's readings, and if so, by how much. The results showed that the readings increased after both procedures, but the increase was larger after polishing than after hydrogen peroxide application. These findings may help clinicians better interpret DIAGNOdent readings after cleaning stained teeth.
详细描述
In this randomized, single-blind, split-mouth clinical study, 126 posterior teeth from 24 adult participants with clinically visible occlusal fissure staining were evaluated. For each participant, opposing jaws were randomly assigned to receive either mechanical polishing with a fluoride-free prophylaxis paste (30 seconds) or a 35% hydrogen peroxide gel (15 minutes). DIAGNOdent Pen laser fluorescence measurements were recorded at three time points: baseline, after air-water spray cleaning and drying, and after the assigned surface procedure. Digital bite-wing radiographs were obtained as a non-invasive clinical reference. Within-group comparisons were analyzed using the Wilcoxon signed-rank test, and between-protocol comparisons were analyzed using a linear mixed-effects model with patient as a random effect and surface procedure as a fixed effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
The radiograph assessor was blinded to the assigned surface procedure.
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
- 是
入选标准
- •Age between 18 and 65 years
- •Clinically visible staining in the fissures of at least two permanent posterior teeth
- •Absence of cavitation, restoration, or sensitivity in the involved teeth
排除标准
- •Presence of restorations on the involved teeth
- •Evident cusp loss, wear, fracture, or cracks on the occlusal surface
- •Enamel cracks
- •Hypocalcification lesions
研究组 & 干预措施
Mechanical Polishing
Fluoride-free prophylaxis paste (Cleanic, Kerr, Salerno, Italy) applied to the fissure area using a polishing brush attached to a micromotor at 10,000 rpm for 30 seconds with light pressure using circular movements, followed by water spray rinse and air drying.
干预措施: Mechanical Polishing with Fluoride-Free Prophylaxis Paste (Procedure)
35% Hydrogen Peroxide
In-office bleaching agent containing 35% hydrogen peroxide (Whiteness HP, FGM Dental, Brazil), prepared per manufacturer's instructions (3 drops peroxide, 1 drop thickener), applied to completely cover stained fissure areas for 15 minutes, then aspirated and rinsed with water and air dried.
干预措施: 35% Hydrogen Peroxide Application (Procedure)
结局指标
主要结局
Change in DIAGNOdent Score
时间窗: Measured at baseline and immediately after the assigned surface procedure (within a single clinical session)
Change in DIAGNOdent Pen laser fluorescence score, calculated as the post-surface-procedure value minus the baseline value, measured at the deepest point of the occlusal fissure. The DIAGNOdent Pen (KaVo, Biberach, Germany) scale ranges from 0 to 99, with higher scores indicating greater fluorescence and a higher likelihood of caries-related or stain-related tissue changes.
次要结局
- DIAGNOdent Score Change After Air-Water Spray Cleaning(Baseline and immediately after air-water spray cleaning (single clinical session, same-day))
- Between-Group Comparison of DIAGNOdent Score Change(Baseline and immediately post-procedure (single clinical session, same-day))
研究者
Özlem Erçin Sultanzade
Associate Professor
Istanbul Kent University