Comparison of the Brackets Bonded With Bulk Fill Composite and Conventional Composite in Patients Undergoing Fixed Orthodontic Treatment - A Split-mouth Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Survival Time of Orthodontic Bracket Bond
研究概览
简要总结
The primary objective of this study is to compare the survival rate (days) of orthodontic bracket bond to the tooth, and the secondary objective is to compare the dental plaque accumulation and gingival health using plaque index and gingival index respectively between brackets bonded with bulk fill composite and light cure conventional composite in patients undergoing fixed orthodontic treatment over a period of three months.
详细描述
After obtaining approval from the Ethical Review Committee and taking informed assent and informed consent from the child and parents respectively, patients fulfilling the study selection criteria will be recruited in the study as participants. Patients visiting the orthodontic clinic at the Aga Khan University Hospital Karachi will be included in this study. Detailed information regarding the study will be provided to the participants and they will be given the choice to either accept or refuse their inclusion in the study. Bulk fill composite and light cure conventional composite will be used to bond the brackets in the study participants undergoing orthodontic treatment. Bulk fill composite and light cure conventional composite will be randomly allocated to the right and left quadrants of maxillary and mandibular arches. Bracket bond failure and clinical measurements (plaque accumulation and gingival health) will be recorded at four intervals. First, at the time of brackets bonding (T0), after one month (T1), two months (T2) and three months follwow-up (T3). Data will be collected on an organized study proforma.
Interim analysis will be run to ensure that there are no unexpected safety concerns associated with the intervention. The analysis may help determine whether the intervention is effective in achieving its desired outcomes or if there are indications of potential success. If the interim analysis will reveal overwhelming evidence of effectiveness or futility, the trial will be terminated early, saving time, money, and potential exposure to participants.
Intention to treat analysis will be applied to maintain the benefits of randomization and avoid introducing bias due to non-adherence or dropouts. By analyzing participants as part of their original assigned group, the ITT analysis provides a more conservative estimate of treatment effects, reflecting real-world scenarios where not everyone perfectly adheres to the assigned treatment.
Randomization:
Block randomization will be used to determine which side of teeth (right or left side quadrants) the bulk-fill composite will be used to bond the brackets in each participant. This will be controlled by a research faculty member of the Section of Dentistry assigned to the research by the Clinical Trials Unit AKUH.
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
- None
入排标准
- 年龄范围
- 13 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Patients aged between 13 - 40 years
- •Patients undergoing fixed orthodontic treatment
- •Patients with good oral hygiene, with grade 1 or below on plaque and gingival indices
- •All patients who will sign the informed consent/assent form
排除标准
- •• Patients with enamel surface defects
- •Patients with any periodontal disease i.e. gingivitis or periodontitis
- •Patients with any systemic diseases i.e. diabetes and hypertension
- •Pregnant or nursing females
- •Patients with craniofacial syndromes
- •Subjects with a previous history of orthodontic or orthopedic treatment
结局指标
主要结局
Survival Time of Orthodontic Bracket Bond
时间窗: First, at the time of brackets bonding (T0), after one month (T1), two months (T2) and three months follwow-up (T3).
The number of days the bonded orthodontic brackets remain adhered to the tooth surface without failure. Bracket bond failure will be recorded at each follow-up visit, and survival time will be calculated for each bracket in both intervention groups (bulk fill composite vs conventional composite). The aim is to compare the average survival duration between the two materials over the study period.
次要结局
- Plaque Accumulation and Gingival Health(First, at the time of brackets bonding (T0), after one month (T1), two months (T2) and three months follwow-up (T3).)
研究者
Rizwan Khalil
Resident Orthodontic
Aga Khan University Hospital, Pakistan