Clinical Effectiveness of a Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Bracket Bond Failure Rate
研究概览
简要总结
This randomized clinical trial aims to evaluate the clinical effectiveness of a remineralizing self-etch primer used for orthodontic bracket bonding. The study compares bonding performance, enamel surface effects, and clinical outcomes between the experimental primer and the conventional bonding protocol,verify the potential remineralization effect, and examine the amount of adhesive remnants left on enamel over a period of 6 months.
详细描述
To evaluate the clinical performance of a newly developed self-etch primer (M-SEP) versus P-SEP in bonding metallic orthodontic brackets to different teeth, verify the potential remineralization effect, and examine the amount of adhesive remnants left on enamel over a period of 6 months.
Objectives:
Primary; Evaluating the clinical effectiveness of enamel etching/priming with M-SEP versus P-SEP in achieving clinically adequate bond strengths throughout the assessment of bracket failure rate over a period of 6 months.
Secondary;
- Examining the potential enamel remineralization effect of both systems via the use of Fe-SEM and Raman spectroscopy.
- Assessing the amount of remnant adhesive left post bracket failure (for both systems) via the use of SEM and digital photography.
- Measuring the total time required for remnant adhesive removal post bracket failure/debonding.
- Evaluating patient perception during bracket failure/debonding and subsequent adhesive removal procedure.
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
- Single (Participant)
盲法说明
multi-center, parallel-group, single-blinded randomized clinical trial conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines for orthodontic research.
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full permanent dentition including incisors, canines, premolars, and molars (excepting 3rd molars;
- •Teeth with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide,
- •No previous orthodontic treatment with fixed appliances.
排除标准
- •Participants unable to give informed consent,
- •Had craniofacial anomalies,
- •Require orthognathic surgery as part of their treatment,
- •Had congenital enamel defects.
研究组 & 干预措施
Split-mouth bonding: SEP 1 right/LL vs SEP 2 left/LR
Patients receive fixed MBT stainless-steel brackets bonded with two self-etch primers in a split-mouth design. Maxillary right and mandibular left incisors, canines, and premolars are etched with SEP 1; maxillary left and mandibular right counterparts are etched with SEP 2. All teeth are polished with fluoride-free pumice, brackets bonded with Transbond XT, and standard NiTi-stainless-steel archwire sequence used in both arches.
干预措施: Remineralizing self-etch primer (M-SEP, SEP 1) (Device)
Split-mouth bonding: SEP 1 right/LL vs SEP 2 left/LR
Patients receive fixed MBT stainless-steel brackets bonded with two self-etch primers in a split-mouth design. Maxillary right and mandibular left incisors, canines, and premolars are etched with SEP 1; maxillary left and mandibular right counterparts are etched with SEP 2. All teeth are polished with fluoride-free pumice, brackets bonded with Transbond XT, and standard NiTi-stainless-steel archwire sequence used in both arches.
干预措施: Standard self-etch primer (P-SEP, SEP 2) (Device)
Split-mouth bonding: SEP 1 left/LR vs SEP 2 right/LL
Patients receive the same fixed MBT stainless-steel appliance and archwire sequence as Group A. In this arm, maxillary left and mandibular right incisors, canines, and premolars are etched with SEP 1, while maxillary right and mandibular left counterparts are etched with SEP 2. Bonding follows identical polishing, priming, Transbond XT application, and LED light-curing protocol as in Group A.
干预措施: Remineralizing self-etch primer (M-SEP, SEP 1) (Device)
Split-mouth bonding: SEP 1 left/LR vs SEP 2 right/LL
Patients receive the same fixed MBT stainless-steel appliance and archwire sequence as Group A. In this arm, maxillary left and mandibular right incisors, canines, and premolars are etched with SEP 1, while maxillary right and mandibular left counterparts are etched with SEP 2. Bonding follows identical polishing, priming, Transbond XT application, and LED light-curing protocol as in Group A.
干预措施: Standard self-etch primer (P-SEP, SEP 2) (Device)
结局指标
主要结局
Bracket Bond Failure Rate
时间窗: 6 MONTH
Documented as a percentage of brackets debonded during the 6-month observation period, categorized by location (incisor, canine, premolar) and cause (adhesive failure, cohesive failure, bracket fracture .
次要结局
- Adhesive Remnant Index(6 MONTH)
- Adhesive Remnant Index(6 MONTH)
研究者
Ali I Ibrahim
Professor
University of Baghdad