Evaluation of Silver-Hydroxyapatite Nano-coated Versus Uncoated Orthodontic Miniscrews for en Masse Retraction of the Upper Anterior Segment: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Assessment of the clinical and radiographically success rate of nanocoated versus uncoated orthodontic miniscrews after en masse retraction
研究概览
简要总结
study will be directed to evaluate silver-hydroxyapatite nano-coated versus uncoated orthodontic miniscrews for en masse retraction of the upper anterior segment.
详细描述
Silver-hydroxyapatite nanoparticles (Ag-HA NPs) have lately gained popularity in dentistry due to their unique combination of silver antibacterial activity and hydroxyapatite's osteoconductive, remineralizing characteristics. Ag-HA has shown potential in resolving two important clinical issues: infection control and anchoring stability. Coating orthodontic miniscrews with Ag-HA NPs has been demonstrated to reduce peri-implant biofilm growth by their antimicrobial effect, minimizing inflammation, and increasing osseointegration, thus increasing the long-term success of temporary anchoring devices (TADs).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Class I orthodontic cases with bimaxillary protrusion of the anterior segment of the upper jaw that need at least extraction for orthodontic treatment.
- •Age 14-20 years.
- •Good oral hygiene with healthy periodontium.
- •Need for an absolute skeletal anchorage.
- •Systemically healthy patients.
排除标准
- •Patient with craniofacial anomalies (e.g, cleft lip and palate)
- •Presence of systemic diseases or syndromes affecting bone metabolism (e.g, osteoporosis, rickets)
- •Poor oral hygiene or uncooperative patients.
- •Extensive dental caries or untreated periodontal disease.
- •History of trauma or surgery affecting the maxilla or mandible.
研究组 & 干预措施
uncoated titanium miniscrews
Patients will receive conventional uncoated titanium miniscrews of the same dimensions and design as Arm 1, but without nano-coating.
干预措施: uncoated titanium miniscrews (Device)
silver-hydroxyapatite nanocoated titanium miniscrews
Patients will receive silver-hydroxyapatite nanocoated titanium miniscrews. These miniscrews will be placed in the maxillary bone for en masse retraction of the upper anterior teeth.
干预措施: Silver nanoparticles (Device)
结局指标
主要结局
Assessment of the clinical and radiographically success rate of nanocoated versus uncoated orthodontic miniscrews after en masse retraction
时间窗: about 6 months
Assessment of the clinical and radiographically success rate of nanocoated versus uncoated orthodontic miniscrews after en masse retraction
次要结局
- Assessment of the rate of en masse retraction of the anterior segment of the upper arch(6 months)
研究者
Hashem Khalil Saleh Mohammed
Principle Investigator, MSc Candidate in Orthodontics
Al-Azhar University