The Effectiveness of Gold Fixed Retainers Compared to Conventional Stainless Steel Retainers: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in mandibular incisor alignment (Little's Irregularity Index, ΔLII)
研究概览
简要总结
This randomized clinical trial will compare the effectiveness of a gold-plated multistranded mandibular fixed retainer versus a conventional multistranded stainless-steel fixed retainer in maintaining lower anterior tooth alignment after completion of orthodontic treatment. Eligible participants (post-orthodontic patients requiring mandibular fixed retention) will be allocated in a 1:1 ratio to receive either a gold-plated 0.0195-inch multistranded retainer or an identical-gauge 0.0195-inch stainless-steel multistranded retainer. Participants will be followed for 6 months.
The primary outcome is post-treatment stability of mandibular anterior alignment, assessed by changes in Little's Irregularity Index over time, along with retainer failure outcomes (e.g., time to first failure and tooth-level failure events). Secondary outcomes include periodontal health indices and related clinical measures collected at baseline and follow-up visits.
For the microbiological assessment, plaque/biofilm will be collected from the retainer using sterile swabs at 1 month, 3 months, and 6 months to evaluate bacterial levels associated with each retainer material.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Masking is used for participants, outcome assessors, and the data analyst. The treating orthodontist (care provider) who places the fixed retainer cannot be blinded due to visible differences between the retainer wire types. Participants are not informed of group assignment. Outcome assessments are performed on coded study records/models by a blinded examiner, and the dataset is coded prior to statistical analysis, which is conducted by a blinded data analyst.
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
- •Age: 15-30 years.
- •Patients who have completed comprehensive orthodontic treatment ,with well-aligned mandibular anterior teeth (Little's Irregularity Index ≤ 0.5 mm) at debond; both extraction and non-extraction cases are eligible.
- •Patients with good oral hygiene and healthy periodontium at baseline; no previous bonded retainer.
- •All mandibular anterior teeth present (canine-canine), with sound lingual enamel suitable for bonding.
排除标准
- •Patients with a history of rapid maxillary expansion (RME) or surgically assisted RME (SARME).
- •Patients with a cleft lip / and or palate (craniofacial anomalies).
- •Patients with marked deep overbite and/or parafunctional habits (e.g., bruxism, clenching).
- •Patients with conditions precluding reliable bonding in the mandibular anterior segment (active caries, extensive restorations, enamel fractures) or missing teeth from canine to canine.
- •Patients with medical/periodontal conditions likely to affect gingival health (e.g., active periodontitis, uncontrolled systemic disease).
结局指标
主要结局
Change in mandibular incisor alignment (Little's Irregularity Index, ΔLII)
时间窗: Baseline (T0) to 6 months after retainer placement (assessed at 1, 3, and 6 months)
Little's Irregularity Index (LII) is a quantitative scale of mandibular anterior alignment, calculated as the sum of the linear displacements (in mm) of the contact points of the six mandibular anterior teeth. Scores range from 0 mm (perfect alignment, no irregularity) to ≥10 mm (very severe irregularity); higher scores indicate greater crowding and therefore a worse outcome. LII will be measured for the mandibular anterior teeth (canine-to-canine) at baseline (T0, before fixed-retainer placement) and at follow-up visits (T1 = 1 month, T2 = 3 months, T3 = 6 months). The primary endpoint is the change in LII (follow-up LII minus baseline LII), comparing gold-plated versus stainless-steel fixed-retainer groups.
Time to first fixed-retainer failure (survival)
时间窗: From retainer placement to 6 months after placement.
Time (days) from fixed retainer bonding to the first failure event requiring repair/rebonding/replacement. Failures will be recorded and classified (e.g., adhesive-enamel debond, wire-composite debond, wire fracture, partial/complete loosening) and compared between groups.
次要结局
- Plaque accumulation at mandibular anterior teeth (Silness-Löe Plaque Index)(Baseline and 1, 3, and 6 months.)
- Microbiological plaque outcome(Follow-up visits at 1 month (T1), 3 months (T2), and 6 months (T3) after retainer placement.)
- Change in mandibular inter-canine width(Baseline (T0, before retainer placement) and follow-up visits at 1 month (T1), 3 months (T2), and 6 months (T3).)
- Gingival inflammation at mandibular anterior teeth (Löe-Silness Gingival Index)(Baseline and 1, 3, and 6 months after retainer placement.)
- Probing pocket depth at mandibular anterior teeth(Baseline and 1, 3, and 6 months after retainer placement.)
- Change in mandibular arch length(Baseline (T0, before retainer placement) and 1, 3, and 6 months (T1, T2, T3) after retainer placement.)
- Change in overjet(Baseline (T0, before retainer placement) and 1, 3, and 6 months (T1, T2, T3) after retainer placement.)
- Change in overbite(Baseline (T0, before retainer placement) and 1, 3, and 6 months (T1, T2, T3) after retainer placement.)
研究者
Noor Sattar Raheem
Postgraduate Researcher (Principal Investigator)
University of Baghdad