EVALUATION of PREVENTIVE EFFECT of SEALANTS and LASER THERAPY on DENTAL CARIES and POSTERUPTIVE BREAKDOWN on MOLARS AFFECTED with MOLAR INCISOR HYPOMINERALISATION (RANDOMIZED CLINICAL TRIAL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Post-eruptive breakdown / dental caries
研究概览
简要总结
Background: Molar Incisor Hypomineralisation (MIH) is a qualitative defect of enamel that shows asymmetrical involvement of one to four permanent first molars (PFM) with or without incisor teeth involvement. MIH molars are prone to post-eruptive breakdown (PEB) and to the development of atypical caries lesions.
Aim of the study: To evaluate and compare the preventive effect of glass ionomer sealant and laser therapy (LT) against dental caries and PEB on molars affected by molar incisor hypomineralisation (MIH) Materials and Method: This study is a two-arm, parallel group, randomized clinical trial. A sample of children (n=134) with an age range of 6-9 years old, having a first permanent molar erupted with MIH without PEB or carious lesion, will be selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. All selected 134 first permanent molars will be randomly and equally allocated into two groups. Group 1(n=67): LT and Group 2 (n=67): Glass ionomer sealant (Fuji triage). Dental caries, PEB, retention of sealant and child-self-reported discomfort will be clinically evaluated after 6, 12 and 18months. Associations between dental caries and PEB with independent variables will be evaluated using logistic regression analysis (p < 0.05).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6-9 years old children (29)
- •One tooth with MIH with no PEB according to evaluation criteria proposed by Ghanim (2017) (APPENDIX I) (30) and ICDAS scores 0, 1 and 2 (APPENDIX II) (31)
- •Good overall health (ASA I) (APPENDIX III) (32)
排除标准
- •First permanent molars with active carious lesions with ICDAS scores 5 and 6 (Appendix II) or defective restorations (31)
- •Sufficient dentin loss that requires restorative therapy
- •Any clinical signs of failure (abscess, fistula)
研究组 & 干预措施
Test group
This group will be subjected to laser therapy. Er,Cr:YSGG will be used (Waterlase®, Biolase, USA) of a wavelength of 2780 nm at a power of 0.75 W using a frequency of 20 Hz and pulse duration of 140 µs. Irradiation will be performed on the entire occlusal and at the hypomineralized areas. The laser tip will pass in a uniform scanning motion steadily for 20 sec with relative isolation with 11% air and no water-cooling system. During the laser treatment, all safety measures will be followed.
干预措施: Laser therapy (Procedure)
Control group
This group will receive glass ionomer sealant. Conditioning of the surface will be done using polyacrylic acid (10%) conditioner for 20 seconds, then rinsed and dried. Fuji triage will be applied after activating and mixing the capsule. Light cure for 20 seconds. Occlusion will be checked using articulating paper and necessary adjustments will be done using finishing burs.
干预措施: Glass ionomer sealant (Procedure)
结局指标
主要结局
Post-eruptive breakdown / dental caries
时间窗: 21 months
Initially, two examiners (MB and GW) will be pre-trained and calibrated to perform the MIH diagnosis based on the criteria described by Ghanim (2017). and ICDAS
次要结局
未报告次要终点
研究者
Marwa Baraka
Lecturer, Pediatric dentistry department
Alexandria University