跳至主要内容
临床试验/NCT07229105
NCT07229105已完成不适用

Comparative Effectiveness of Remineralization Agents on Attachment-Associated Demineralization in Clear Aligner Patients: A 6-Month DIAGNOdent-Based Observational Study

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Change in Enamel Demineralization (DIAGNOdent values).

研究概览

简要总结

Background/ Objectives: Clear aligner attachments increase the risk of white spot lesions (WSL), with a 35.5% incidence in adolescents. The number of anterior attachments is an independent risk factor (OR=2.192). Despite 17 million patients treated worldwide, no study has quantitatively assessed demineralization around attachment margins. To compare the effectiveness of CPP-ACP, nano-hydroxyapatite (nHAp), and fluoride varnish versus a control for attachment-associated demineralization using DIAGNOdent monitoring.

Methods: This prospective observational study evaluated 52 patients; 45 were enrolled, and 40 completed after five pre-baseline withdrawals. Participants were allocated to four groups (n=10 each): Group A (control, fluoride toothpaste), Group B (CPP-ACP daily), Group C (nHAp professional + home gel), and Group D (fluoride varnish quarterly). DIAGNOdent measurements were taken around attachments at baseline, 1, 3, and 6 months. Linear mixed-effects models analyzed group differences (p<0.05).

详细描述

DIAGNOdent Measurement Protocol Calibration and Standardization The DIAGNOdent pen (KaVo, Biberach, Germany) was calibrated before each measurement session according to the manufacturer's instructions using a ceramic standard[18]. A single calibrated examiner performed all measurements to ensure consistency. Intra-examiner reliability was assessed using intraclass correlation coefficient (ICC) with two-way mixed model, absolute agreement, calculated from 30 repeated measurements at 10 randomly selected attachment sites (ICC = 0.85, 95% CI: 0.79-0.91).

Measurement Technique A standardized measurement protocol was employed for all DIAGNOdent assessments. Teeth were air-dried for 5 seconds prior to measurement, and the probe tip was positioned perpendicular to the enamel surface to ensure consistent readings. Four measurements were obtained per attachment site at the mesial, distal, gingival, and occlusal margins. Three measurement passes were performed at each site, with the maximum value recorded to represent the most advanced demineralization present. Measurements were conducted at four timepoints: baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
16 Years 至 45 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 16-45 years
  • Active clear aligner treatment with minimum 6 months remaining
  • Presence of ≥10 attachments on anterior teeth and premolars
  • Good general health
  • Commitment to prescribed aligner wear (20-22 hours/day)

排除标准

  • Active carious lesions
  • Periodontal disease
  • Fluorosis or enamel hypoplasia
  • Current fluoride supplement use beyond standard toothpaste
  • Pregnancy or lactation
  • Systemic conditions affecting salivary flow

研究组 & 干预措施

Group B: Casein Phosphopeptide-Amorphous Calcium Phosphate

Experimental

In addition to standard fluoride toothpaste, participants applied GC Tooth Mousse (CPP-ACP) to their clear aligners once daily for 15 minutes before bedtime.

干预措施: GC Tooth Mousse (Device)

Group C: Nano-Hydroxyapatite

Experimental

Professional in-office application of 5% nHAp gel at baseline, 1, and 3 months, combined with daily home application of 1% nHAp gel into aligners.

干预措施: Nano-Hydroxyapatite Gel (Device)

Group D: Professional Fluoride Varnish

Experimental

Professional application of 5% sodium fluoride varnish (ProShield) applied to attachment margins at baseline and 3 months.

干预措施: Sodium Fluoride varnish (Drug)

结局指标

主要结局

Change in Enamel Demineralization (DIAGNOdent values).

时间窗: Baseline (T0) to 6 months (T3).

Measurements taken using DIAGNOdent pen around attachment margins. Validated cut-off values: 0-12 sound, 13-24 initial, \>25 advanced.

次要结局

  • Temporal Changes in Enamel Mineralization(1 month (T1) and 3 months (T2))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Banu Kılıç

Assistant Professor

Bezmialem Vakif University

研究点 (1)

Loading locations...

相似试验