An interventional study of Mechanical toothbrushing (fluoride toothpaste) and Chlorhexidine mouthwash (0.2%) in Gingivitis and Dental Plaque, sponsored by Riyadh Elm University. Not yet recruiting at 1 site in Saudi Arabia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Riyadh Elm University · Not applicable, Interventional, and Prevention
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:
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.
631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's planned enrollment of 21 is below the median of 66 across 507 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Riyadh Elm University is the lead sponsor of 26 studies on the registry; 10 are open to participants now.
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Minimum planned aligners remaining: ≥ 11 aligners (assuming 10 days/aligner) or equivalent continuous CA duration per treating orthodontist.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Mechanical toothbrushing (fluoride toothpaste) · Drug: Chlorhexidine mouthwash (0.2%) · Other: Oxygen-based cleanser
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.
Behavioral: Mechanical toothbrushing (fluoride toothpaste) · Drug: Chlorhexidine mouthwash (0.2%) · Other: Oxygen-based cleanser
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.
Behavioral: Mechanical toothbrushing (fluoride toothpaste) · Drug: Chlorhexidine mouthwash (0.2%) · Other: Oxygen-based cleanser
Control oral-hygiene period using mechanical toothbrushing with a fluoride-containing toothpaste, per standardized study instructions, for the assigned 1-month period. No chlorhexidine or oxygen-based cleanser is used during this period; aligners are removed for oral-hygiene procedures per protocol.
Also known as: Colgate Total
Chlorhexidine mouthwash used per standardized study instructions for the assigned 1-month period. No oxygen-based cleanser is used during this period; aligners are removed for mouthrinse use and oral-hygiene procedures per protocol. A 1-week washout without cleaning products separates periods.
Also known as: CHX
Oxygen-based cleanser (BlueM) used per standardized study instructions for the assigned 1-month period. No chlorhexidine is used during this period; aligners are removed for product use and oral-hygiene procedures per protocol. A 1-week washout without cleaning products separates periods.
Also known as: BlueM
Fusobacterium nucleatum CFU in supragingival plaque at the gingival margin (index teeth)
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).
Time frame: Baseline and end of each 1-month period (end of Period 1, Period 2, Period 3); 1-week washouts between periods.
Fusobacterium nucleatum CFU on retrieved aligner inner-surface biofilm
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).
Time frame: Baseline and end of each 1-month period (end of Period 1, Period 2, Period 3); 1-week washouts between periods.
Prevotella intermedia CFU on retrieved aligner inner-surface biofilm
Anaerobic culture enumeration (CFU) of Prevotella intermedia from a standardized inner-surface swab of the used aligner (zones corresponding to the gingival margins of the index teeth).
Time frame: 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)
Anaerobic culture enumeration (CFU) of Prevotella intermedia from supragingival plaque collected along the gingival margin of upper/lower first molars and central incisors using the study's standardized swab/microbrush protocol.
Time frame: Baseline and end of each 1-month period (end of Period 1, Period 2, Period 3); 1-week washouts between periods.
MMP-8 concentration/activity in matrix-paired plaque and aligner extracts
MMP-8 measured from paired extracts obtained from supragingival plaque and retrieved aligner inner-surface biofilm collected from the same participant at each time point.
Time frame: 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
Plaque Index recorded at the upper and lower first molars and central incisors; six sites per tooth.
Time frame: Baseline and end of each 1-month period (end of Period 1, Period 2, Period 3).
Gingival Index (GI) at index teeth
Gingival Index recorded at the upper and lower first molars and central incisors; six sites per tooth.
Time frame: Baseline and end of each 1-month period (end of Period 1, Period 2, Period 3).
Bleeding on Probing (BoP) at index teeth
BoP recorded at the upper and lower first molars and central incisors; six sites per tooth.
Time frame: Baseline and end of each 1-month period (end of Period 1, Period 2, Period 3).
Plan to share: Undecided — Individual participant data (IPD) sharing will follow Riyadh Elm University IRB and SFDA requirements. A de-identified dataset (microbiological counts/abundances, MMP-8 values, periodontal indices, randomization order, and minimal demographics) may be shared after primary publication, subject to IRB approval and a data-use agreement
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Chlorhexidine
Riyadh Elm University