A prospective RCT for the comparison between Self etching primer and conventional acid etching technique with the effectiveness of the pumice prophylaxis in orthodontic bonding.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- NUMBER OF BOND FAILURE
研究概览
简要总结
This study aims to contribute more evidence-based research to the existing orthodontic literature. The following conclusions can be drawn based on the findings of this clinical investigation:
1. Conventional acid etching with pumice prophylaxis (Group A1) exhibited the lowest bond failure rate (5.0%) over the 9-month observation period and showed statistically significant superiority (p = 0.015) in long-term bracket retention compared to other groups, reaffirming its reliability as the gold standard for bonding.
2. Self-etching primers (SEP) significantly reduced chairside bonding time due to a simplified application process. The shortest mean bonding time was observed in Group B2 (115.6 sec), while Group A1 took the longest (156.55 sec). These differences were highly statistically significant (p < 0.001).
3. Pumice prophylaxis significantly enhanced bond strength and reduced bond failure rates in both conventional and SEP systems. The bond failure rate in Group B2 (SEP without pumice) was 18.0%, which was significantly higher than in Group B1 (SEP with pumice) at 8.0%, confirming that pumice use significantly improves enamel preparation (p = 0.035 for B1 vs. B2).
4. Most bracket failures occurred in the first 6 months, particularly in Group B2 (15.0%), and the chi-square analysis showed statistical significance at this stage (p = 0.040). This highlights the critical role of precise bonding technique and patient compliance in the early treatment phase.
5. While SEP systems offer time efficiency, they may compromise bond reliability—particularly without pumice. For consistent clinical success, clinicians should strive for a balance between procedural efficiency and long-term bond stability, using pumice prophylaxis with SEP when necessary, and maintaining traditional CAE with pumice as the most dependable bonding protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with good oral hygiene.
- •Patients required fixed mechanotherapy therapy.
排除标准
- •Enamel hypoplasia and demineralization.
- •Fluorosis of teeth.
- •Teeth with restoration on labial/buccal surface.
- •Teeth with prosthesis.
结局指标
主要结局
NUMBER OF BOND FAILURE
时间窗: 6 months | 9 months
次要结局
- Chairside time required(After bonding)
研究者
Harshkumar Gandhi
Faculty of dental science, Dharmsinh Desai University