Efficiency of Er:YAG Laser Therapy in Combination With Behaviour Management Technique in Reducing Anxiety Among Paediatric Dental Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- self-report dental anxiety on a modified version of the self-report Faces Scale by LeBaron
研究概览
简要总结
The aim of the study is to assess the efficacy of a modified version of the behaviour management technique Latent inhibition in combination with Er:YAG laser for achieving reduction of dental anxiety in paediatric dental patients. The main objectives are to compare dental anxiety felt during the laser and conventional dental treatment. The outcomes will be dental anxiety assessment by a self-reported anxiety during treatment in both group as well as measurement of heart rate dynamics during the procedures.
详细描述
When providing dental care to child patients with a high level of dental anxiety, the range of approaches are divided into two sections - use of behavior management techniques and application of alternative methods for caries removal. In attempt to reduce dental anxiety, they can be mixed and matched in accordance with the dentists' choice. Owing to the promoted advantages Er:YAG laser turns into an ideal alternative technique for hard dental tissue therapy in anxious pediatric patients.This is a protocol for a randomized controlled clinical trial. The participants will be children aged aged 6-12 years, requiring conservative treatment of occlusal carious lesions on a second primary molar. Patients will be randomly assigned to experimental or control group via computer-generated sequence. In both groups Latent inhibition will be used as an anxiety-management technique. In the experimental group caries treatment will be performed with Erbium:YAG laser, whereas in the control group with the conventional rotary instruments. Outcome measures will be dental anxiety felt before and after the treatment and the dynamics of heart rate, registered during the treatment session.
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
The randomisation will be independent and the patients and parents/guardians will remain blinded to group status.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants in the study are children aged 6-12 years, compliant with the cognitive development of the child and the requirement for complete root development;
- •Children, requiring conservative treatment of occlusal carious lesions on a second primary molar, without spontaneous unprovoked pain, percussion or palpation pain or other symptoms, indicating pulp involvement or periodontal pathology. Lesions are classified as distinct cavity with visible dentin without prior restoration or sealants by the International Caries Detection and Assessment System (ICDAS) with code
- •Included are caries lesions only on vital teeth.
- •Children with one or more permanent molars giving indications for pit and fissure sealing;
- •Patients without previous experience with laser treatment of carious lesions;
- •Children who are not considered medically compromised or medically complex patients;
- •Verbal assent from the child willing to comply with all study procedures and protocol;
- •Obtained written informed consent by the patient's parent/guardian for participation in the study
排除标准
- •Patients who were undergoing therapy with neurological, sedative, analgesic, and/or anti-inflammatory drugs 7 days prior to treatment that might affect heart rate;
- •Children, who were first-time dental patients;
- •Children with systemic diseases or physiological development delays;
- •Children with mental or cognitive problems;
- •Present infectious diseases such as influenza, scarlet fever, etc.
- •Excluded are molars which are affected by disturbances in the development of dental structures (hypoplasia, hypomineralization, fluorosis)
研究组 & 干预措施
Er:YAG laser therapy
Er:YAG laser will be used for enamel conditioning of the occlusal surfaces of the permanent molars before sealant application as well as the standardized caries treatment.
干预措施: Laser conditioning and Sealant application (Procedure)
Er:YAG laser therapy
Er:YAG laser will be used for enamel conditioning of the occlusal surfaces of the permanent molars before sealant application as well as the standardized caries treatment.
干预措施: Er:YAG laser therapy (Device)
Conventional therapy
Conventional rotary instruments will be used for caries treatment.
干预措施: Sealant application (Procedure)
Conventional therapy
Conventional rotary instruments will be used for caries treatment.
干预措施: Conventional therapy (Procedure)
结局指标
主要结局
self-report dental anxiety on a modified version of the self-report Faces Scale by LeBaron
时间窗: Immediately after the dental treatment
The scale comprises a row of five faces ranging from 'relaxed' to 'very worried' in combination with a visual analog scale of 0 - 10. Each child was asked to point to the face or choose the number which most closely depicted its state of anxiety.
次要结局
- Heart rate(start: in the waiting room, at least 5 minutes before the dental treatment. End: at least 5 minutes after the dental treatment.)