Comparison of the Clinical Effects of Er:YAG Laser-Assisted and Conventional Cavity Preparation on Pain, Dental Anxiety, Sensory Responses, and Patient Comfort in Children With Molar-Incisor Hypomineralization
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Pain-Related Behavior Assessed Using the FLACC Scale
研究概览
简要总结
This randomized clinical trial compares Er:YAG laser-assisted and conventional rotary cavity preparation in children aged 6-12 years with molar-incisor hypomineralization. A total of 52 children are randomly assigned to one of the two preparation methods. The study evaluates pain, dental anxiety, sensory experiences, physiological responses, patient comfort, need for local anesthesia, and procedure duration. Postoperative discomfort and the clinical performance of restorations are also assessed during follow-up visits at 1, 3, and 6 months.
详细描述
This prospective, parallel-group, randomized clinical trial was conducted to compare the clinical effects of Er:YAG laser-assisted and conventional rotary cavity preparation in children with molar-incisor hypomineralization. Fifty-two children aged 6-12 years requiring restorative treatment of a mandibular first permanent molar were allocated in a 1:1 ratio to either the Er:YAG laser group or the conventional rotary instrument group.
In the laser group, cavity preparation was performed using an Er:YAG laser. In the conventional group, rotary instruments were used. Local anesthesia was not routinely administered but was provided when clinically required. Following cavity preparation, the teeth were restored using the same adhesive system and resin composite material in both groups.
Pain and behavioral responses were assessed using the Wong-Baker FACES Pain Rating Scale and the Face, Legs, Activity, Cry, Consolability scale. Dental anxiety was evaluated before and after treatment using the Modified Child Dental Anxiety Scale-Faces version. Heart rate and peripheral oxygen saturation were recorded as physiological indicators. Sensory experiences, overall discomfort, willingness to undergo the same procedure again, need for local anesthesia, cavity preparation time, and total procedure time were also recorded. Postoperative discomfort and the clinical performance of the restorations were evaluated at 1-, 3-, and 6-month follow-up visits.
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
盲法说明
Masking was not feasible because the laser-assisted and conventional preparation methods produced distinguishable visual, auditory, and sensory experiences for the participants and clinical investigators.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 to 12 years.
- •Diagnosis of molar-incisor hypomineralization according to the European Academy of Paediatric Dentistry diagnostic criteria.
- •Presence of mild or moderate molar-incisor hypomineralization.
- •Presence of an erupted mandibular first permanent molar (tooth 36 or 46) requiring restorative treatment.
- •Presence of a single-surface occlusal carious lesion classified as ICDAS code 4 or
- •Vital target tooth without clinical or radiographic signs of pulpal or periapical pathology.
- •No previous restorative treatment of the target tooth.
- •Cooperative behavior corresponding to Frankl behavior rating scores 3 or 4 and Venham scores 0 to
- •Written informed consent provided by a parent or legal guardian.
- •Child assent to participate in the study.
排除标准
- •Presence of a systemic or neurodevelopmental condition that could affect pain perception, anxiety, communication, or cooperation.
- •Use of analgesic, anxiolytic, sedative, or other medication that could influence pain or anxiety assessment before treatment.
- •Presence of spontaneous dental pain, irreversible pulpitis, pulp necrosis, or periapical pathology in the target tooth.
- •Requirement for multisurface cavity preparation or extensive restorative treatment.
- •Previous restorative treatment of the target tooth.
- •Inability of the child or parent/legal guardian to understand or complete the study assessments.
- •Refusal of the child or parent/legal guardian to participate.
研究组 & 干预措施
Er:YAG Laser-Assisted Cavity Preparation
Cavity preparation was performed using an Er:YAG laser, followed by restoration with an adhesive system and resin composite.
干预措施: Er:YAG Laser-Assisted Cavity Preparation (Device)
Conventional Rotary Cavity Preparation
Cavity preparation was performed using conventional rotary instruments, followed by restoration with the same adhesive system and resin composite.
干预措施: Conventional Rotary Cavity Preparation (Procedure)
结局指标
主要结局
Pain-Related Behavior Assessed Using the FLACC Scale
时间窗: During cavity preparation
Pain-related behavior during cavity preparation was assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale. The total score ranges from 0 to 10, with higher scores indicating greater pain-related behavioral responses.
Self-Reported Pain Assessed Using the Wong-Baker FACES Pain Rating Scale
时间窗: Immediately after cavity preparation
Pain experienced during cavity preparation was self-reported using the Wong-Baker FACES Pain Rating Scale. Scores range from 0 to 10, with higher scores indicating greater pain.
次要结局
- Dental Anxiety Assessed Using the Modified Child Dental Anxiety Scale-Faces Version(Immediately before and immediately after the restorative procedure)
- Change in Heart Rate(From immediately before to immediately after the restorative procedure)
- Change in Peripheral Oxygen Saturation(From immediately before to immediately after the restorative procedure)
- Sensory experience and patient comfort(Immediately after the restorative procedure)
- Requirement for Local Anesthesia(During cavity preparation)
- Cavity Preparation Duration(During the restorative procedure)
- Total Restorative Procedure Duration(During the restorative procedure)
- Patient-Reported Discomfort Assessed Using a Visual Analog Scale(Immediately before treatment, immediately after treatment, and at 1-, 3-, and 6-month follow-up visits)
- Clinical Performance of Restorations Assessed Using FDI Criteria(At 1-, 3-, and 6-month follow-up visits)
研究者
Buse KORKUT IŞIK
Research Assistant, Principal Investigator
Ege University