Clinical Evaluation of Two Minimally Invasive Protocols for Orthodontic Clean-Up: A Case-Control Study
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
- 否
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
Simona Tecco
Associate Professor
IRCCS San Raffaele
