Accuracy and Periodontal Outcomes of Three Interproximal Enamel Reduction Techniques During Clear Aligner Therapy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Accuracy of interproximal enamel reduction (IPR) (planned vs performed, mm)
研究概览
简要总结
This randomized controlled clinical trial will compare three commonly used interproximal enamel reduction (IPR) techniques during clear aligner therapy in adult patients. IPR is a routine orthodontic procedure in which a small amount of enamel is removed between teeth to create space and help achieve the planned alignment.
Seventy-five adults (18 years and older) indicated for receiving clear aligner treatment with IPR prescribed in their digital treatment plan will be enrolled at the orthodontic clinics of Riyadh Elm University (Riyadh, Saudi Arabia) and randomized in a 1:1:1 ratio to one of three IPR techniques: manual abrasive strips (manual arm), motor-driven oscillating strips (motor-driven arm), or abrasive discs (abrasive arm). IPR will be performed by the same trained operator according to the assigned technique.
The primary outcome is IPR accuracy, defined as the difference between the amount of IPR planned digitally and the amount performed clinically, measured using intraoral scans taken before and immediately after IPR. Secondary outcomes are short-term periodontal outcomes, assessed on IPR teeth only using plaque and gingival bleeding indices at baseline and at a 6-week follow-up visit. The data analyst will be blinded to group allocation
详细描述
2.1. Aim This study aims to compare, in patients undergoing clear aligner therapy, the accuracy of interproximal enamel reduction (IPR) and the short term periodontal effects among three techniques: manual hand strips, motor driven oscillating strips, and abrasive discs.
2.2 Objectives
- To Quantify and compare the accuracy of interproximal enamel reduction among manual hand strips, motor driven oscillating strips, and abrasive discs during clear aligner therapy.
- To Evaluate and compare the short term periodontal effects of IPR among manual hand strips, motor driven oscillating strips, and abrasive discs
- Hypothesis and/ or Research Question:
There is no difference between manual hand strips, motor driven oscillating strips, and abrasive discs in the accuracy of interproximal enamel reduction and in the short term changes in plaque index and bleeding on probing. 4. Materials and Methods:
4.1. Study Design This study will be a single-blinded randomized controlled clinical trial with three parallel arms and equal allocation of 1:1:1 conducted at the orthodontic clinics of Riyadh Elm University, Riyadh, Saudi Arabia. The trial will be registered at ClinicalTrials.gov and approval will be obtained from the Saudi Food and Drug Authority with ethical approval from Riyadh Elm University Institutional Review Board (IRB).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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 with full permanent dentition.
- •Undergoing clear aligner therapy (Invisalign) with a ClinCheck treatment plan that includes interproximal enamel reduction (IPR).
- •Periodontally healthy at baseline (per clinic screening).
排除标准
- •Orthodontic treatment plan including extractions.
- •Proximal restorations or caries on any tooth surface targeted for IPR.
- •Current smoking.
- •Diabetes mellitus or other systemic diseases known to affect periodontal status.
研究组 & 干预措施
Manual arm
Interproximal enamel reduction will be performed at the prescribed contacts using manual abrasive strips (6 mm separating abrasive strips, coarse; Ortho Organizers, Inc., Carlsbad, USA). (n = 25)
干预措施: Manual Arm (Procedure)
Motor-driven arm
Interproximal enamel reduction will be performed at the prescribed contacts using motor-driven oscillating strips (OK Strips Kit with JAINTEK EVA handpiece operated at < 15,000 rpm; JAINTEK Co., Ltd., Guri-si, Republic of Korea). (n = 25).
干预措施: Motor Driven Arm (Procedure)
Abrasive arm
Interproximal enamel reduction will be performed at the prescribed contacts using abrasive discs (OK DIA DISC, double-sided, thickness 0.15 mm; JAINTEK Co., Ltd., Guri-si, Republic of Korea). (n = 25).
干预措施: Abrasive Arm (Procedure)
结局指标
主要结局
Accuracy of interproximal enamel reduction (IPR) (planned vs performed, mm)
时间窗: Baseline (pre-IPR intraoral scan) to immediately after IPR (post-IPR intraoral scan), same visit
Planned IPR (mm) will be extracted from the participant's initial digital treatment plan (ClinCheck) for the contacts scheduled for IPR at the study visit. Performed IPR (mm) will be quantified using intraoral scans obtained immediately before and immediately after IPR. STL files will be analyzed in OrthoCAD to measure the mesiodistal tooth widths of incisors, canines, and premolars receiving IPR. The amount of performed IPR will be calculated as the difference in the summed mesiodistal widths of the included teeth before vs after IPR (pre-IPR minus post-IPR). IPR accuracy will be calculated per participant as the discrepancy between planned and performed IPR (mm) and compared across the three groups.
次要结局
- Changes in plaque Index(Baseline (pre-IPR) to 6 weeks after IPR.)
- Changes in gingival bleeding index(Baseline (pre-IPR) to 6 weeks after IPR.)
研究者
Omar Alkadhi
Associate Professor of Orthodontics
Riyadh Elm University