Safety and Effectiveness of Er:YAG Laser in Cavity Preparation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain Intensity During Cavity Preparation
研究概览
简要总结
The goal of this clinical trial is to compare Er:YAG laser cavity preparation with conventional rotary instruments in adults who have permanent premolars planned for extraction as part of orthodontic treatment.
The main questions the study aims to answer are:
How do Er:YAG laser and conventional rotary instruments compare in the time needed for cavity preparation? Do participants experience different levels of pain with the two methods? Which cavity preparation method do participants prefer after experiencing both methods? Are there differences in cavity surface and interface characteristics and microleakage between teeth prepared with the two methods?
Researchers will compare Er:YAG laser cavity preparation with conventional rotary cavity preparation using a split-mouth design. Each participant will receive both treatment methods on two different eligible permanent premolars.
Participants will:
Have one eligible premolar prepared with an Er:YAG laser and another eligible premolar prepared with conventional rotary instruments.
Have the two procedures performed at separate visits on different days. Rate their pain after each procedure and indicate which treatment method they would prefer for future dental treatment.
Have the study teeth extracted approximately 1 month later, as already planned for their orthodontic treatment.
After extraction, the teeth will be examined in the laboratory to compare cavity surface and interface characteristics and microleakage between the two preparation methods.
详细描述
This is an interventional, split-mouth study designed to evaluate the safety and effectiveness of Er:YAG laser cavity preparation compared with conventional rotary instrumentation.
Adult participants undergoing orthodontic treatment who have permanent premolars scheduled for extraction will be enrolled. Two eligible permanent premolars from each participant will be included. A Class I cavity will be prepared using an Er:YAG laser in one tooth and conventional rotary instruments in the other tooth. Both procedures will be performed by the same dentist at separate visits on different days.
Clinical assessments will include the time required for cavity preparation, pain experienced immediately after each procedure, changes in pulse rate during treatment, and the participant's preferred treatment method after experiencing both techniques.
Following cavity preparation, the teeth will be restored with composite resin. Approximately one month later, the study teeth will be extracted according to the participant's pre-existing orthodontic treatment plan. The extracted teeth will then undergo ex vivo laboratory evaluation.
Selected specimens will be examined using scanning electron microscopy to assess cavity and tooth-restoration interface characteristics. Laboratory evaluation will also assess microleakage between the two cavity preparation methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and the treating clinician will not be masked because of the obvious procedural differences between Er:YAG laser and conventional rotary instrumentation. For the ex vivo microleakage assessment, two examiners blinded to the cavity preparation method will independently evaluate dye penetration.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult participants with permanent maxillary or mandibular premolars scheduled for extraction for orthodontic reasons.
- •Eligible premolars are intact or have carious lesions limited to the enamel and are free of pain symptoms.
- •Where carious lesions are present, teeth meet the study eligibility criteria based on ICDAS II 2009, as specified in the study protocol.
- •Participants voluntarily agree to participate and provide informed consent.
- •No spontaneous or continuous dental pain.
- •Clinical examination, thermal pulp testing, and electric pulp testing are consistent with normal pulp status.
- •Radiographic examination shows no periapical radiolucency and complete root apex formation.
- •Participants have no systemic health condition that could adversely affect healing.
排除标准
- •Participants with psychological or behavioral conditions that prevent adequate cooperation with the study procedures.
- •Teeth showing radiographic evidence of internal root resorption or pulp canal calcification.
研究组 & 干预措施
Er:YAG Laser Cavity Preparation
One eligible permanent premolar from each participant will undergo Class I cavity preparation using an Er:YAG laser. Each participant will also receive conventional rotary cavity preparation on another eligible permanent premolar as part of the split-mouth design.
干预措施: Er:YAG Laser (Procedure)
Conventional Rotary Cavity Preparation
Another eligible permanent premolar from each participant will undergo Class I cavity preparation using conventional rotary instrumentation. Each participant will also receive Er:YAG laser cavity preparation on another eligible permanent premolar as part of the split-mouth design.
干预措施: Conventional Rotary Cavity Preparation (Procedure)
结局指标
主要结局
Pain Intensity During Cavity Preparation
时间窗: Immediately after each cavity preparation procedure at each of the two treatment visits
Participant-reported pain intensity will be assessed immediately after each cavity preparation procedure using the Wong-Baker pain scale, ranging from 0 to 10, with higher scores indicating greater pain. Pain scores after Er:YAG laser cavity preparation and conventional rotary cavity preparation will be compared within participants.
次要结局
- Treatment Procedure Time(Periprocedural, from the start to the completion of cavity preparation at each of the two treatment visits.)
- Heart Rate During Cavity Preparation(Immediately before and during each cavity preparation procedure)
- Participant Treatment Preference(Immediately after the second treatment visit, approximately 1 week after the first treatment visit.)
- Presence of Cavity Surface Burning on SEM(Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction)
- Presence of Cavity Surface Carbonization on SEM(Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction)
- Presence of Cavity Margin Cracks on SEM(Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction)
- Hybrid Layer Thickness(Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction)
- Adhesive Layer Thickness(Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction)
- Partially Demineralized Dentin Zone Thickness(Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction)
- Microleakage Dye Penetration(Approximately 1 month after cavity preparation, following orthodontically indicated tooth extraction)