Comparison of Periodontal Health Parameters Using Conventional Versus Digital Vacuum Formed Retainer (VFR).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 主要终点
- Plaque Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Digital Vacuum-Formed Retainer (Device)
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.
干预措施: Conventional Vacuum-Formed Retainer (Device)
结局指标
主要结局
Plaque Index
时间窗: 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
Gingival Index
时间窗: 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
Periodontal Pocket Depth
时间窗: 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
次要结局
未报告次要终点
研究者
Syed Riaz Hashim
Postgraduate Student, FCPS Orthodontics
Ziauddin University