A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Bracket Failure Rate
研究概览
简要总结
This randomized, split-mouth clinical trial will evaluate a new orthodontic adhesive that eliminates the need for acid etching before bracket bonding. Conventional orthodontic bonding requires etching enamel with phosphoric acid, which can weaken the outer enamel layer and increase the risk of white spot lesions and enamel damage. The etch-free adhesive under investigation is designed to simplify the bonding procedure while preserving enamel integrity.
Twenty orthodontic patients starting treatment with braces will participate. For each patient, one side of the mouth (left or right) will be randomly assigned to receive the etch-free adhesive, while the opposite side will receive the conventional adhesive with acid etching. This intra-patient design allows a direct comparison under identical oral conditions.
Participants will be followed for 12 months. Bracket failures, bonding time, ease of adhesive removal, enamel surface condition after debonding, and the presence of white spot lesions will be recorded. If effective, the etch-free adhesive may reduce enamel damage without compromising bond strength, providing a safer and more efficient bonding option for orthodontic patients.
详细描述
This is a prospective, randomized, split-mouth clinical trial designed to compare the bond failure rate, bonding efficiency, and enamel outcomes of a novel etch-free orthodontic adhesive with a conventional acid-etch adhesive over a 12-month follow-up period.
Background and Rationale Conventional orthodontic bonding requires phosphoric acid etching to create surface roughness for adhesive retention. While effective, this process irreversibly demineralizes enamel and may increase susceptibility to white spot lesions (WSLs), decalcification, and enamel fractures during bracket removal.
A new generation of self-adhesive bonding materials eliminates the etching step by bonding directly to enamel. This simplified approach may preserve enamel integrity, reduce chair time, and improve the patient experience while maintaining adequate bond strength.
The split-mouth design allows direct intra-patient comparison of the two bonding methods under identical oral conditions (hygiene, diet, occlusal forces), reducing inter-patient variability.
Study Design Type: Prospective, randomized, split-mouth trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single-blinded (Outcome Assessor)
入排标准
- 年龄范围
- 14 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 14 to 35 years
- •Requiring comprehensive fixed orthodontic treatment with brackets on both arches
- •Good general health with no contraindications to orthodontic treatment
- •Presence of at least 10 permanent teeth per arch suitable for bracket bonding
- •Ability and willingness to comply with study visits and follow-up for at least 12 months
- •Parent/guardian consent and child assent obtained as appropriate
排除标准
- •Presence of systemic diseases or conditions that affect oral health or healing (e.g., uncontrolled diabetes, immunosuppression)
- •Teeth with significant enamel defects, restorations, or caries in bonding areas
- •Patients currently undergoing or who have undergone orthodontic treatment previously
- •History of allergy or sensitivity to dental adhesives or related materials
- •Patients with poor oral hygiene or active periodontal disease
- •Use of medications known to affect tooth enamel or oral tissues (e.g., long-term corticosteroids)
- •Inability to attend follow-up visits or anticipated lack of compliance
- •Participation in another clinical trial that could interfere with study outcomes
研究组 & 干预措施
Etch-Free Adhesive
Teeth on one randomized side of the mouth will be bonded with a novel self-adhesive orthodontic material that does not require prior acid etching or primer application.
干预措施: Etch-Free Adhesive (Device)
Conventional Etch-and-Bond Adhesive
Teeth on the contralateral side of the mouth will be bonded using the standard orthodontic bonding protocol with 35-37% phosphoric acid etching, primer, and conventional resin adhesive.
干预措施: Conventional Etch-and-Bond Adhesive (Device)
结局指标
主要结局
Bracket Failure Rate
时间窗: Through study completion, up to 12 months post-bonding (evaluated at each routine orthodontic visit).
The proportion of brackets bonded with each adhesive (etch-free vs. conventional) that experience bond failure over a 12-month follow-up period. A bond failure is defined as a clinically detached bracket requiring rebonding.
次要结局
- White Spot Lesion (WSL) Formation(At baseline (Day 1), 6 months, and 12 months post-bonding.)
- Bonding Time Per Quadrant(At the initial bonding appointment (Day 1).)
- Adhesive Remnant Index (ARI) at Debonding(At debonding (approximately 12 months post-bonding or at completion of treatment).)
- Enamel Surface Integrity(At debonding (approximately 12 months post-bonding).)
研究者
Flavio Copello
Dr Flavio Copello, DDS, Principal Investigator, Clinical Assistant Professor
University of Maryland, Baltimore