Effectiveness of a Hydroxyapatite-Containing Toothpaste Versus Mouthwash in Preventing White-Spot Lesions During Fixed-Appliance Orthodontic Treatment: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Severity of White Spot Lesions assessed by Gorelick Index
研究概览
简要总结
This study aims to evaluate the effect of hydroxyapatite-containing toothpaste and mouthwash in preventing white spot lesions in patients undergoing orthodontic treatment.
Participants: 75 patients will be divided into three groups:
- Group A: Participants will brush their teeth three times a day using hydroxyapatite toothpaste and rinse twice a day with a placebo mouthwash.
- Group B: Participants will brush their teeth three times a day using fluoride toothpaste and rinse twice a day with hydroxyapatite mouthwash.
- Group C (Control Group): Participants will brush their teeth three times a day using fluoride toothpaste and rinse twice a day with a placebo mouthwash.
Patients will be followed during their orthodontic treatment to assess the development of white spot lesions.
The study is safe and involves no surgical procedures or risky medications, and will be conducted under the supervision of Principal Investigator Heba Masri after obtaining ethical approval.
详细描述
This randomized, three-group study aims to evaluate the effectiveness of hydroxyapatite in preventing white spot lesions during orthodontic treatment in patients who initially do not have these lesions.
Study Design:
- Total Participants: 75 patients (25 per group)
- Duration: Throughout orthodontic treatment
- Groups:
- Group A: Brush teeth three times daily with hydroxyapatite toothpaste and rinse twice daily with placebo mouthwash.
- Group B: Brush teeth three times daily with fluoride toothpaste and rinse twice daily with hydroxyapatite mouthwash.
- Group C (Control): Brush teeth three times daily with fluoride toothpaste and rinse twice daily with placebo mouthwash.
Outcome Assessments:
All assessments of white-spot lesions will be performed using Diagnodent Pen, Gorlick index (GI), digital photographs, Gingival Bleeding Index (GBI), Plaque Index (PI), and salivary pH measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All included participants will be drawn from those who will receive comprehensive orthodontic treatment and fulfill the following inclusion criteria:
- •Complete permanent dentition up to the first premolar, with no intended extractions in orthodontic treatment plan.
- •Good overall health.
- •Good oral hygiene: full-mouth plaque score < 20%.
- •No bleeding upon probing after 30 seconds.
- •Discontinuous band of plaque at the gingival margin.
- •Normal stimulated salivary flow rate.
- •Normal buffer capacity (final pH between 6.0 and 7.0) -
排除标准
- •1. History of previous orthodontic treatment.
- •Bleaching or topical fluoridation within the last six months.
- •Severely rotated any of the study teeth (limiting the appearance of facial surfaces).
- •4. Visible signs of caries, fluorosis, hypocalcification, or other developmental defects.
- •Restoration on the labial surface of the study teeth.
- •Systemic or endocrine conditions (e.g., cardiac pacemakers, diabetes mellitus).
- •7. Craniofacial anomalies and clefts.
结局指标
主要结局
Severity of White Spot Lesions assessed by Gorelick Index
时间窗: Baseline, 1,3 months, and 6 months
Severity of white spot lesions on labial tooth surfaces assessed using the Gorelick index during orthodontic treatment. Time Frame: Baseline to 6 months Unit of Measure: Score
Enamel Demineralization assessed by DIAGNOdent
时间窗: Baseline, 1,3 months, and 6 months
Enamel demineralization level measured using DIAGNOdent laser fluorescence device during orthodontic treatment. Unit of Measure: DIAGNOdent score (laser fluorescence units)
次要结局
- Plaque Index(Baseline, 1, 3 months, 6 months)
- Gingival Bleeding Index(Baseline, 1,3to and 6 months)
- Salivary pH(Baseline, 1,3 and 6 months)
研究者
Heba Tahseen Almasri
Principal Investigator
University of Baghdad