Bacterial Diversity Study Using 16S rRNA Sequencing of Periodontal Samples From Patients With Orthodontic Retainers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Longitudinal change in subgingival microbial community composition assessed using Bray-Curtis dissimilarity
研究概览
简要总结
After completion of orthodontic treatment, a retention phase is required to prevent relapse of tooth malposition. Fixed retention in the mandibular anterior region is commonly used. This type of retainer is bonded to the lingual surfaces of the canines and incisors and may hinder oral hygiene, thereby promoting bacterial plaque accumulation and gingival inflammation.
Currently, probably due to the increasing use of clear aligner therapy, clear removable Essix-type retainers are becoming more widely used. Since these retainers can be removed by the patient, they may facilitate oral hygiene. However, studies assessing gingival health and the composition of the subgingival microbiota in patients wearing orthodontic retainers remain scarce.
Therefore, the aim of this study will be to assess the composition of the gingival sulcus microbiota and gingival health in patients wearing fixed or removable orthodontic retainers.
Ten adult patients who have completed orthodontic treatment will be recruited and divided into two groups:
- Fixed retention group.
- Removable retention group.
Periodontal parameters will be assessed, and bacterial plaque samples will be collected from the gingival sulcus at five time points:
T0: Bracket removal and dental scaling appointment. Periodontal parameters will be assessed, and plaque samples will be collected before bracket debonding and dental scaling.
T1: Retainer placement appointment, three days after T0. Periodontal parameters will be assessed, and plaque samples will be collected before retainer placement.
T2: One month after retainer placement.
T3: Three months after retainer placement.
T4: Six months after retainer placement.
详细描述
The objectives of this study are:
- To compare the gingival sulcus microbiota in patients wearing fixed versus removable orthodontic retainers.
- To compare periodontal health in patients wearing fixed versus removable orthodontic retainers.
This prospective interventional comparative study will evaluate changes in gingival health and in the subgingival microbiota of adult patients following completion of orthodontic treatment with fixed multibracket appliances.
Ten participants attending the University Dental Clinic will be assigned to one of two retention groups: a fixed mandibular retainer group or a removable Essix-type retainer group.
Participants in the fixed retention group will receive a lingual retainer bonded from the mandibular left canine to the mandibular right canine, corresponding to teeth 33 to 43 according to the FDI tooth-numbering system. The same type of wire and bonding material will be used for all participants in this group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study will be open-label because fixed and removable orthodontic retainers are readily distinguishable. Participants, care providers and investigators will be aware of the assigned retention method.
Microbiological samples will be coded, and laboratory personnel performing 16S rRNA sequencing and bioinformatic analysis will be unaware of group allocation.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment involving both dental arches
- •Permanent dentition with at least 24 teeth
- •Treatment duration longer than 12 months
- •Treatment using the Versatile MBT system with a 0.022-inch slot
排除标准
- •Patients with systemic disease or taking medications that may affect periodontal health
- •Inadequate restorations or active carious lesions
- •iodontal disease
- •Plaque index greater than 20% before placement of the retainer or during the study
- •Use of oral antiseptics within the previous 6 months or during the study period
- •Use of antibiotics within the previous 14 days or during the study period
- •Pregnant or breastfeeding women
- •Presence of open gingival embrasures, crowding, or dental malposition in the mandibular anterior region after orthodontic treatment
研究组 & 干预措施
Fixed Orthodontic Retention
Participants assigned to this arm will receive a fixed lingual orthodontic retainer bonded to the mandibular anterior teeth, extending from tooth 33 to tooth 43. The same retainer wire and bonding materials will be used for all participants
干预措施: Fixed Orthodontic Retainer (Device)
Removable Essix-Type Orthodontic Retention
Participants assigned to this arm will receive a clear removable Essix-type orthodontic retainer. Participants will be instructed to wear the retainer for 22 hours per day. All retainers will be manufactured using the same material and by the same dental technician.
干预措施: Removable Essix-Type Orthodontic Retainer (Device)
结局指标
主要结局
Longitudinal change in subgingival microbial community composition assessed using Bray-Curtis dissimilarity
时间窗: T0: pre-debonding; T1: pre-retainer baseline, 3 days after T0; T2: 1 month post-retainer; T3: 3 months post-retainer; T4: 6 months post-retainer.
Subgingival plaque samples collected from the mandibular anterior teeth will be analyzed using 16S rRNA gene sequencing. Overall microbial community composition will be assessed using the Bray-Curtis dissimilarity index. Longitudinal differences in microbial community composition will be evaluated between participants receiving fixed orthodontic retainers and those receiving removable Essix retainers, considering the effect of study group, assessment time point, and their interaction.
Longitudinal change in bleeding on probing
时间窗: T0: pre-debonding; T1: pre-retainer baseline, 3 days after T0; T2: 1 month post-retainer; T3: 3 months post-retainer; T4: 6 months post-retainer.
Bleeding on probing will be recorded as present or absent at six sites per tooth in the mandibular anterior region following gentle periodontal probing. The outcome will be calculated as the percentage of examined sites showing bleeding for each participant. Longitudinal changes in bleeding on probing will be compared between participants receiving fixed orthodontic retainers and those receiving removable Essix retainers, considering the effect of study group, assessment time point, and their interaction.
次要结局
- Longitudinal change in subgingival microbial taxonomic composition(T0: pre-debonding; T1: pre-retainer baseline, 3 days after T0; T2: 1 month post-retainer; T3: 3 months post-retainer; T4: 6 months post-retainer.)
- Longitudinal change in subgingival microbial alpha diversity assessed using the Shannon diversity index(T0: pre-debonding; T1: pre-retainer baseline, 3 days after T0; T2: 1 month post-retainer; T3: 3 months post-retainer; T4: 6 months post-retainer.)
- Longitudinal change in subgingival microbial evenness assessed using Pielou's evenness index(T0: pre-debonding; T1: pre-retainer baseline, 3 days after T0; T2: 1 month post-retainer; T3: 3 months post-retainer; T4: 6 months post-retainer.)
- Longitudinal change in subgingival microbial dominance assessed using the Simpson dominance index(T0: pre-debonding; T1: pre-retainer baseline, 3 days after T0; T2: 1 month post-retainer; T3: 3 months post-retainer; T4: 6 months post-retainer.)
- Differential abundance of subgingival bacterial taxa(T0: pre-debonding; T1: pre-retainer baseline, 3 days after T0; T2: 1 month post-retainer; T3: 3 months post-retainer; T4: 6 months post-retainer.)
- Longitudinal change in plaque index(T0: pre-debonding; T1: pre-retainer baseline, 3 days after T0; T2: 1 month post-retainer; T3: 3 months post-retainer; T4: 6 months post-retainer.)
- Longitudinal change in periodontal probing depth(T0: pre-debonding; T1: pre-retainer baseline, 3 days after T0; T2: 1 month post-retainer; T3: 3 months post-retainer; T4: 6 months post-retainer.)
- Longitudinal change in clinical attachment level(T0: pre-debonding; T1: pre-retainer baseline, 3 days after T0; T2: 1 month post-retainer; T3: 3 months post-retainer; T4: 6 months post-retainer.)
- Longitudinal change in gingival recession(T0: pre-debonding; T1: pre-retainer baseline, 3 days after T0; T2: 1 month post-retainer; T3: 3 months post-retainer; T4: 6 months post-retainer.)