Investigating the Impact of Cleaning Protocols on Oral Microbial Ecology and Early Dysbiosis Markers on Orthodontic Clear Aligner Patients: A Randomized Cross-over Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Fusobacterium nucleatum CFU in supragingival plaque at the gingival margin (index teeth)
研究概览
简要总结
This randomized crossover study will assess how three aligner-cleaning methods affect early supragingival oral microbial ecology and periodontal health in adults using clear aligners. Each participant will complete three (1-month) periods in a randomized sequence with (1-week) washouts between periods:
- Mechanical toothbrushing with fluoride toothpaste (control),
- Chlorhexidine (CHX) mouthwash, and
- an oxygen-based cleanser (BlueM).
Primary ecological outcomes focus on early dysbiosis indicators Fusobacterium nucleatum and Prevotella intermedia measured on retrieved aligner inner-surface biofilm and on supragingival plaque at the gingival margin. Secondary outcomes include periodontal indices (plaque index, gingival index, bleeding on probing) at index teeth and the host inflammatory marker MMP-8 in matrix-paired extracts (plaque and aligner).
Study visits occur at baseline and at the end of each 1-month period. Supragingival plaque is collected from the upper and lower first molars and central incisors; used aligners are swabbed immediately after removal. Participants are instructed to wear aligners about 22 hours/day, change trays every 10 days, remove aligners for meals and oral hygiene, and drink only water while aligners are in.
Laboratory procedures include blinded culture enumeration under coded labels (performed by a single trained operator, FA), confocal laser scanning microscopy, and RNA isolation with species-specific qRT-PCR; microscopy is conducted unblinded after decoding. The study will determine whether chlorhexidine or an oxygen-based cleanser produces more favorable early ecological changes and periodontal outcomes than mechanical brushing alone in clear aligner therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Culture enumeration from plaque and retrieved aligners will be processed under coded labels (P1-P3) by a single trained operator (FA) who is masked to protocol assignment. Microscopy and clinical assessments will be conducted unblinded after decoding.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (≥18 years).
- •Undergoing or scheduled for treatment with clear aligners (CA).
- •Presence of upper and lower first molars and central incisors.
- •Periodontal health at baseline (no sites with PD ≥ 4 mm; no clinical attachment loss at index teeth; BI/PI within normal limits).
- •No periodontal therapy within the previous 6 months.
- •Able and willing to comply with study instructions and follow-up visits; signed informed consent.
- •Sufficient remaining CA treatment (clinician-estimated): ≥ 14 weeks to safely cover three 1 month protocol periods plus washouts.
- •Minimum planned aligners remaining: ≥ 11 aligners (assuming 10 days/aligner) or equivalent continuous CA duration per treating orthodontist.
排除标准
- •Patients requiring orthognathic surgery
- •Uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus, autoimmune disease).
- •Pregnancy or lactation.
- •Use of systemic antibiotics and/or anti-inflammatory drugs within the last 3 months.
- •Periodontal therapy within the last 6 months.
- •Current tobacco use (smoking/smokeless) or vaping.
- •Limited/express CA plans (e.g., ≤ 11 aligners or expected completion < 14 weeks).
- •Anticipated early completion of CA or major treatment changes (e.g., switch to fixed appliances) within the next ~4 months.
- •- Extensive caries, defective restorations, or prostheses affecting index teeth/sites.
研究组 & 干预措施
Sequence ABC: Brushing then CHX Mouthwash then BlueM
Participant completes three 1-month periods in order (A to B to C), each separated by a 1-week washout. A = Mechanical toothbrushing with fluoride toothpaste (control); B = Chlorhexidine (CHX) mouthwash; C = Oxygen-based cleanser (BlueM). Trays are changed every 10 days; aligners are worn 22 h/day; water-only while aligners are in.
干预措施: Mechanical toothbrushing (fluoride toothpaste) (Behavioral)
Sequence ABC: Brushing then CHX Mouthwash then BlueM
Participant completes three 1-month periods in order (A to B to C), each separated by a 1-week washout. A = Mechanical toothbrushing with fluoride toothpaste (control); B = Chlorhexidine (CHX) mouthwash; C = Oxygen-based cleanser (BlueM). Trays are changed every 10 days; aligners are worn 22 h/day; water-only while aligners are in.
干预措施: Chlorhexidine mouthwash (0.2%) (Drug)
Sequence ABC: Brushing then CHX Mouthwash then BlueM
Participant completes three 1-month periods in order (A to B to C), each separated by a 1-week washout. A = Mechanical toothbrushing with fluoride toothpaste (control); B = Chlorhexidine (CHX) mouthwash; C = Oxygen-based cleanser (BlueM). Trays are changed every 10 days; aligners are worn 22 h/day; water-only while aligners are in.
干预措施: Oxygen-based cleanser (Other)
Sequence BCA: CHX Mouthwash then BlueM then Brushing
Participant completes three 1-month periods in order (B to C to A), each separated by a 1-week washout. A = Mechanical toothbrushing with fluoride toothpaste (control); B = CHX mouthwash; C = Oxygen-based cleanser (BlueM). Trays are changed every 10 days; aligners are worn 22 h/day; water-only while aligners are in.
干预措施: Mechanical toothbrushing (fluoride toothpaste) (Behavioral)
Sequence BCA: CHX Mouthwash then BlueM then Brushing
Participant completes three 1-month periods in order (B to C to A), each separated by a 1-week washout. A = Mechanical toothbrushing with fluoride toothpaste (control); B = CHX mouthwash; C = Oxygen-based cleanser (BlueM). Trays are changed every 10 days; aligners are worn 22 h/day; water-only while aligners are in.
干预措施: Chlorhexidine mouthwash (0.2%) (Drug)
Sequence BCA: CHX Mouthwash then BlueM then Brushing
Participant completes three 1-month periods in order (B to C to A), each separated by a 1-week washout. A = Mechanical toothbrushing with fluoride toothpaste (control); B = CHX mouthwash; C = Oxygen-based cleanser (BlueM). Trays are changed every 10 days; aligners are worn 22 h/day; water-only while aligners are in.
干预措施: Oxygen-based cleanser (Other)
Sequence CAB: BlueM then Brushing then CHX Mouthwash
Participant completes three 1-month periods in order (C to A to B), each separated by a 1-week washout. A = Mechanical toothbrushing with fluoride toothpaste (control); B = CHX mouthwash; C = Oxygen-based cleanser (BlueM). Trays are changed every 10 days; aligners are worn 22 h/day; water-only while aligners are in.
干预措施: Mechanical toothbrushing (fluoride toothpaste) (Behavioral)
Sequence CAB: BlueM then Brushing then CHX Mouthwash
Participant completes three 1-month periods in order (C to A to B), each separated by a 1-week washout. A = Mechanical toothbrushing with fluoride toothpaste (control); B = CHX mouthwash; C = Oxygen-based cleanser (BlueM). Trays are changed every 10 days; aligners are worn 22 h/day; water-only while aligners are in.
干预措施: Chlorhexidine mouthwash (0.2%) (Drug)
Sequence CAB: BlueM then Brushing then CHX Mouthwash
Participant completes three 1-month periods in order (C to A to B), each separated by a 1-week washout. A = Mechanical toothbrushing with fluoride toothpaste (control); B = CHX mouthwash; C = Oxygen-based cleanser (BlueM). Trays are changed every 10 days; aligners are worn 22 h/day; water-only while aligners are in.
干预措施: Oxygen-based cleanser (Other)
结局指标
主要结局
Fusobacterium nucleatum CFU in supragingival plaque at the gingival margin (index teeth)
时间窗: Baseline and end of each 1-month period (end of Period 1, Period 2, Period 3); 1-week washouts between periods.
Anaerobic culture enumeration (CFU) of Fusobacterium nucleatum from supragingival plaque collected along the gingival margin of upper/lower first molars and central incisors using the standardized swab/microbrush protocol. Species confirmation per SOP. Culture processing blinded under coded labels (P1-P3) by FA. Metric: CFU per specimen (report also as log10 CFU if analyzed).
Fusobacterium nucleatum CFU on retrieved aligner inner-surface biofilm
时间窗: Baseline and end of each 1-month period (end of Period 1, Period 2, Period 3); 1-week washouts between periods.
Anaerobic culture enumeration (CFU) of Fusobacterium nucleatum from a standardized inner-surface swab of the used aligner (zones corresponding to gingival margins of index teeth). Species confirmation per laboratory SOP. Culture processing blinded under coded labels (P1-P3) by a single trained operator (FA). Metric: CFU per specimen (report also as log10 CFU if analyzed).
次要结局
- Prevotella intermedia CFU on retrieved aligner inner-surface biofilm(Baseline and end of each 1-month period (end of Period 1, Period 2, Period 3); 1-week washouts between periods.)
- Prevotella intermedia CFU in supragingival plaque at the gingival margin (index teeth)(Baseline and end of each 1-month period (end of Period 1, Period 2, Period 3); 1-week washouts between periods.)
- Plaque Index (PI) at index teeth(Baseline and end of each 1-month period (end of Period 1, Period 2, Period 3).)
- Gingival Index (GI) at index teeth(Baseline and end of each 1-month period (end of Period 1, Period 2, Period 3).)
- Bleeding on Probing (BoP) at index teeth(Baseline and end of each 1-month period (end of Period 1, Period 2, Period 3).)
- MMP-8 concentration/activity in matrix-paired plaque and aligner extracts(Baseline and end of each 1-month period (end of Period 1, Period 2, Period 3); 1-week washouts between periods.)
研究者
Faisal Ali Althobaiti
Principal Investigator
Riyadh Elm University