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临床试验/NCT07304310
NCT07304310已完成不适用

Clinical Evaluation of Two Minimally Invasive Protocols for Orthodontic Clean-Up: A Case-Control Study

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2025年4月8日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
142
试验地点
1
主要终点
Plaque Control Record (PCR)

研究概览

简要总结

Orthodontic clean-up following debonding remains a technically demanding procedure, with documented risks of enamel roughening, microdefects, discoloration, and increased plaque retention. Minimally invasive technologies have recently been introduced to improve adhesive removal while limiting damage to the outer enamel layer, but comparative clinical evidence remains limited. This aim of this case-control study was to compare the effectiveness and the safety of two different minimally invasive clean-up systems: two-step ultrasonic inserts (Combi Touch, Mectron) and a one-step polishing bur (One Gloss®, Shofu).

A total of 142 patients presenting residual orthodontic adhesive after debonding were included. They were randomly allocated to: (1) Case group (n = 71): two-step ultrasonic system (Combi Touch, Mectron) equipped with 30-µm diamond-coated and PEEK-coated inserts; (2) Control group (n= 71): one-step tungsten carbide/abrasive polisher (One Gloss®, Shofu). For each patient the following clinical indices were recorded at baseline (T0) and 30-day follow-up (T1): Plaque Control Record (PCR), Bleeding on Probing (BoP), Adhesive Remnant Index (ARI), International Caries Detection and Assessment System (ICDAS-II), and dentinal sensitivity (Schiff Air Index). Orthodontic treatment modality (clear aligners vs fixed appliances) was documented as a covariate and tested for potential interactions with clinical outcomes.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients undergone either fixed vestibular orthodontic treatment or clear aligner therapy
  • Debonding procedure must not have occurred more than 24 months prior to evaluation
  • ICDAS-II index ≤ 2

排除标准

  • Patients treated with removable orthodontic appliances
  • Patients whose debonding exceeded 24 months
  • ICDAS-II score > 2

结局指标

主要结局

Plaque Control Record (PCR)

时间窗: Baseline, after 30 days

The PCR is scored as the percentage of tooth surfaces with visible plaque (0-100%). Higher scores indicate worse oral hygiene.

Schiff Air Index

时间窗: Baseline, after 30 days

The Schiff Air Index scored from 0 to 3, where 0 = no response to air stimulus and 3 = strong painful response. Higher scores indicate greater dentinal hypersensitivity.

Bleeding on Probing (BoP)

时间窗: Baseline, after 30 days

BoP is expressed as the percentage of bleeding sites (0-100%). Higher scores indicate worse gingival health.

Adhesive Remnant Index (ARI)

时间窗: Baseline, after 30 days

The ARI is scored 0-3, where 0 = no adhesive left on tooth surface and 3 = all adhesive remaining. Higher scores indicate more adhesive remaining on the enamel.

International Caries Detection and Assessment System (ICDAS-II)

时间窗: Baseline, after 30 days

The ICDAS-II is scored from 0 to 6, where 0 = sound tooth surface and 6 = extensive cavitated lesion. Higher scores indicate worse caries status.

次要结局

  • Orthodontic treatment modality(Baseline)

研究者

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

Simona Tecco

Associate Professor

IRCCS San Raffaele

研究点 (1)

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