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Digital vs Conventional VFR in Post-Orthodontic Retention

2026年8月13日 更新者:Syed Riaz Hashim、Ziauddin University

Comparison of Periodontal Health Parameters Using Conventional Versus Digital Vacuum Formed Retainer (VFR).

This study is comparing two ways of making a retainer, the clear, removable kind worn after braces to see whether the way it's made affects gum health. One type is made using a digital scan of the teeth, and the other is made the traditional way, using a plaster mold. The study will look at how each type affects plaque buildup, gum swelling, and the depth of the space between the tooth and gum over a six-month period.

About 52 people who have just finished braces on both their upper and lower teeth will take part. Participants will be assigned to one of two groups: one group will receive a digitally made retainer, and the other will receive a traditionally made retainer.

Retainer Fitting Before the study begins, each participant's retainer is custom-made for their teeth, either from a digital scan or a plaster mold, depending on which group they're in. Participants will wear their retainer for 22 hours a day, taking it out only to eat and brush their teeth.

Daily Care Throughout the study, participants will follow the same tooth-brushing and gum-care routine, so that any differences seen between the two groups can be linked to the retainer itself rather than to differences in oral hygiene. Participants will be asked to avoid using mouthwash while wearing the retainer.

Check-Up Visits

Participants will attend four check-ups over six months:

Before the retainer is placed (baseline) One month after placement Three months after placement Six months after placement

At each visit, a dentist will check the teeth and gums for plaque buildup, gum swelling or bleeding, and pocket depth (the space between the tooth and gum) using a small measuring tool called a probe.

Follow-Up The final check-up at six months marks the end of the study for each participant. Participants can leave the study at any time if they choose.

研究概览

详细说明

Orthodontic retention is essential to prevent relapse following active orthodontic treatment, and vacuum-formed retainers (VFRs) are widely used due to their aesthetics and ease of fabrication.

Conventional VFRs are fabricated over a plaster model derived from alginate impressions, while digital VFRs are fabricated over a 3D-printed model generated from an intraoral scan.

This randomized clinical trial compares periodontal health outcomes; Plaque Index, Gingival Index, and Periodontal Pocket Depth, between the two fabrication methods.

Fifty-two participants (26 per arm) aged 15-30 years who have completed non-extraction fixed orthodontic treatment on both arches within the last month will be enrolled via non-probability consecutive sampling. Group A will receive digitally fabricated VFRs; Group B will receive conventionally fabricated VFRs, both made of 1.5 mm PETG material. Participants will wear retainers 22 hours daily and follow standardized oral hygiene instructions.

Periodontal parameters will be assessed on index teeth 16, 21, 31, and 46 at baseline (T0) and at 1, 3, and 6 months (T1-T3) post-placement. Gingival Index will follow the Loe and Silness method; Plaque Index will follow the Silness and Loe method; pocket depth will be measured with a UNC-15 probe at six sites per tooth.

Data will be analyzed in SPSS v27 using independent-sample t-tests/Mann-Whitney U tests for between-group comparisons and paired t-tests for within-group change from baseline, with stratification for age and gender as effect modifiers.

研究类型

介入性

注册 (估计的)

52

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Dr Syed Riaz Hashim Principal Investigator
  • 电话号码:+92 3312763463
  • 邮箱:syed.hashim@zu.edu.pk

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

描述

INCLUSION CRITERIA

  • Patients aged 15-30 years
  • Patients with good oral and general health
  • Patients in which both the arches were treated with fixed orthodontic treatment on a non-extraction basis completed within the last 1 month
  • Patients with minimum 24 permanent teeth present

EXCLUSION CRITERIA

  • Patients that are medically compromised due to a systemic disease
  • Patients having periodontal disease before debonding
  • Patients with severe and uncontrolled caries
  • Patients having cleft palate or any other severe facial deformity
  • Patients using drugs that have direct or indirect effect on the periodontal health such as phenytoin, cyclosporine etc.
  • Patients that have a habit of chronic smoking
  • Pregnant patients

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Group A - Digital VFR
Participants receive a vacuum-formed retainer thermoformed over a 3D-printed model generated from intraoral scanning, worn 22 hours/day for 6 months.
PETG, 1.5 mm, fabricated via intraoral scan and 3D-printed model
有源比较器:Group B - Conventional VFR
Participants receive a vacuum-formed retainer thermoformed over a plaster model generated from alginate impressions, worn 22 hours/day for 6 months.
PETG, 1.5 mm, fabricated via alginate impression and plaster model

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Plaque Index
大体时间:Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3).
(Silness and Loe method) 4-point scale (0-3) scored on four surfaces (facial, lingual, mesial, distal) of index teeth 16, 21, 31, 46
Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3).
Gingival Index
大体时间:Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3).
(Loe and Silness method) 4-point scale (0-3) assessing inflammation and bleeding on four surfaces of index teeth 16, 21, 31, 46
Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3).
Periodontal Pocket Depth
大体时间:Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)
measured in mm with a UNC-15 probe at six sites per index tooth (mesiofacial, midfacial, distofacial, mesiolingual, midlingual, distolingual); deepest site recorded
Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年8月7日

首先提交符合 QC 标准的

2026年8月7日

首次发布 (实际的)

2026年8月12日

研究记录更新

最后更新发布 (实际的)

2026年8月14日

上次提交的符合 QC 标准的更新

2026年8月13日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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