COMPARATIVE ASSESSMENT OF FAILURE RATE AND PERIODONTAL STATUS BETWEEN CAD/CAM GENERATED METAL FIXED LINGUAL BONDED RETAINER AND CONVENTIONAL FIXED LINGUAL BONDED RETAINER: A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. Assessing the failure rate
研究概览
简要总结
Title of the Study: Comparative Assessment of Failure Rate and Periodontal Status Between CAD/CAM Generated Metal Fixed Lingual Bonded Retainer and Conventional Fixed Lingual Bonded Retainer: A Prospective Randomized Controlled Trial
Brief Summary: This is a prospective randomized controlled trial conducted at the Department of Orthodontics and Dentofacial Orthopedics, Indira Gandhi Institute of Dental Sciences (IGIDS), Puducherry. The study aims to compare the clinical performance and periodontal outcomes of CAD/CAM-generated metal fixed lingual bonded retainers versus conventional fixed lingual bonded retainers in post-orthodontic patients.
A total of 50 participants, aged above 16 years and having completed fixed appliance orthodontic treatment, will be randomly assigned into two groups:
- Group 1: CAD/CAM generated stainless steel fixed bonded retainers
- Group 2: Conventional multi-stranded stainless steel fixed bonded retainers
The CAD/CAM retainers will be fabricated using 3D scanning and laser sintering technology, while conventional retainers will be manually formed using stainless steel wires. Both will be bonded using the indirect technique.
Double blinding (patient and assessor) is maintained. The study excludes patients with periodontal disease, anterior extractions, craniofacial anomalies, or nickel allergies.
The study protocol includes all ethical considerations, informed consent/assent in both English and Tamil, and necessary quality control measures.
Primary outcomes include the failure rate of the retainers and the relapse rate assessed through inter-canine width and Little’s irregularity index. Secondary outcomes include evaluation of periodontal status using gingival index, calculus index, periodontal index, and bleeding on probing at baseline and during follow-up visits at 1, 3, and 6 months.
The study utilizes double blinding (participant and assessor) and block randomization. Ethical clearance has been obtained from the Institutional Ethics Committee, and informed consent will be acquired from all participants. The total study duration is one year, and the trial is self-funded.
The findings are expected to inform clinical protocols and enhance long-term orthodontic retention strategies while maintaining periodontal health.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 16.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group above 16 years Completion of treatment with full fixed appliance with optimal overjet and overbite and Occlusions According to the six keys of Andrews Good general and oral health Patients treated by both extraction and non extraction protocols.
排除标准
- •Treatment involving extraction of anterior teeth Conditions contraindicating fixed retainers Craniofacial or severe asymmetry syndromes Periodontally compromised patients Dental restorations or missing teeth on the anterior area Nickel allergy Smoking.
结局指标
主要结局
1. Assessing the failure rate
时间窗: 6 months
2. Assessing the relapse rate
时间窗: 6 months
次要结局
- Assessment of Periodontal status
研究者
DR SHARANJI S V
Indira Gandhi Institute of Dental Sciences