The Effectiveness of Low-level Laser Therapy as an Adjunct Strategy in Orthodontic Retention for Periodontal-compromised Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Changes in probing pocket depth (PPD)
研究概览
简要总结
The aim of the study is to evaluate the effects of low-level laser therapy (LLLT) on patients with chronic periodontitis during a post-orthodontic period for 12 months. Following aspects will be assessed: 1. Effects on tooth stability maintenance and bone remodeling. 2. Effects on periodontal inflammation status. 3. Effects on cervical dentin sensitivity and quality of life. The study design is a randomised controlled trail. To eliminate any bias, the investigator will initially hypothesis there is no significant difference in the aforementioned aspects between teeth retained with an adjunctive LLLT strategy and those retained in a conventional regimen.
详细描述
The study design is a randomised split-mouth design based on the result of investigator's pilot study. Thirty-five non-smoking Ethnic Chinese patients (male and female, age: 25-65 years) with chronic periodontitis will be recruited. The teeth in experimental group will receive LLLT during orthodontic retention period for 12 months, while the teeth in the control (placebo) group will not receive laser therapy. Orthodontic occlusal indices will be measured to explore LLLT's role in maintaining tooth stability. The effects of LLLT on periodontal inflammation status will be evaluated by assessing clinical periodontal parameters and the levels of supra-gingival and sub-gingival bacteria. The effects of LLLT on bone remodelling will be explored by testing the biochemical biomarkers in gingival crevicular fluid (GCF). Cone-beam computed tomography will also be used to provide clinical evidence of periodontal status and bone remodelling. Possible effects of LLLT on patient's quality of life will be investigated via validated questionnaires, subjective assessment of tooth sensitivity, and objective measurement of bite force.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thirty-five non-smoking Ethnic Chinese patients (male or female; age: 25-65 years) will be recruited from the Prince Philip Dental Hospital, Faculty of Dentistry, the University of Hong Kong into the following selection criteria:
- •Systemically health (with special regard to disease affecting tissue repair);
- •No medications required for periodontal therapy and no use of any antibiotic and/or anti-inflammatory medication in the preceding month;
- •Chronic periodontitis with at least two pairs (clinically matched) displaced single-rooted teeth (each pair of teeth is in the same arch but in two contralateral hemi-arches respectively belonging to the same tooth typology) having at least one site probing depth of 5 mm or more, interproximal attachment loss of 3 mm or more, and radiographic signs of alveolar bone loss before periodontal and orthodontic treatment.
- •Recent completion of orthodontic treatment and readiness for debonding and retainer delivery.
排除标准
- •under orthodontic treatment.
结局指标
主要结局
Changes in probing pocket depth (PPD)
时间窗: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
Record the changes of probing pocket depth in millimeters from baseline to 3 months, 6 months and 12 months through probing.
Changes in bleeding on probing (BOP)
时间窗: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
Record the bleeding on probing changes from baseline to 3 months, 6 months and 12 months through probing.
Changes in clinical attachment loss (CAL)
时间窗: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
Record the clinical attachment loss (CAL) changes from baseline to to 3 months, 6 months and 12 months.
Changes in plaque index (PI)
时间窗: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
Record the plaque index (PI) changes from baseline to to 3 months, 6 months and 12 months.
次要结局
- Supragingival and subgingival plaque(debond, 1 month follow-up, 3 month follow-up, 6 month follow-up and 12 month follow-up)
- Cervical dentin sensitivity(debond, each week interval during the first months, 3 months, 6 months and 12 months)
- Maximum voluntary bite force(debond, 1 month follow-up, 3 month follow-up, 6 month follow-up and 12 month follow-up)
- Orthodontic outcome stability(debond, 3 month follow-up, 6 month follow-up and 12 month follow-up)
- Alveolar bone remodelling(debond, 12 month follow-up)