GingivitisNCT07307716
Clear Aligner Cleaning: Brushing, Chlorhexidine, and BlueM Effects on Oral Microbial Ecology and Periodontal Indices
A study testing Mechanical toothbrushing (fluoride toothpaste), Chlorhexidine mouthwash (0.2%) and Oxygen-based cleanser in people with Gingivitis and Dental Plaque, run by Riyadh Elm University at 1 site in Saudi Arabia.
Trial summary
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: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Dental Plaque
- What is being tested?
- Mechanical toothbrushing (fluoride toothpaste), Chlorhexidine mouthwash (0.2%) and Oxygen-based cleanser
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Feb 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
Riyadh Elm University - Orthodontic Clinics
Riyadh, Riyadh Region
Faisal A Althoabiti, BDS, +996594496974, faisal.althobaiti2024@student.riyadh.edu.sa
Nancy M Ajwa, MSc, +966554804564, nancy.ajwa@riyadh.edu.sa
About this study
Official title: 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
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).
Read more
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.
- Conditions
- Gingivitis, Dental Plaque
- Being tested
- Mechanical toothbrushing (fluoride toothpaste), Chlorhexidine mouthwash (0.2%), Oxygen-based cleanser
- Keywords
- Clear aligners, Chlorhexidine, BlueM, Oxygen-based cleanser, Mechanical toothbrushing, Supragingival plaque, Aligner biofilm, Fusobacterium nucleatum, Prevotella intermedia, MMP-8, Plaque index, Gingival index, Bleeding on probing, Randomized crossover
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical toothbrushing (fluoride toothpaste)Behavioural
Also called Colgate Total
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.
Chlorhexidine mouthwash (0.2%)Drug
Also called CHX
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.
Oxygen-based cleanserOther
Also called BlueM
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.
| Study group | Role | What they receive |
|---|---|---|
| Sequence ABC: Brushing then CHX Mouthwash then BlueM | Experimental | 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. Receives: Behavioral: Mechanical toothbrushing (fluoride toothpaste); Drug: Chlorhexidine mouthwash (0.2%); Other: Oxygen-based cleanser |
| Sequence BCA: CHX Mouthwash then BlueM then Brushing | Experimental | 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. Receives: Behavioral: Mechanical toothbrushing (fluoride toothpaste); Drug: Chlorhexidine mouthwash (0.2%); Other: Oxygen-based cleanser |
| Sequence CAB: BlueM then Brushing then CHX Mouthwash | Experimental | 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. Receives: Behavioral: Mechanical toothbrushing (fluoride toothpaste); Drug: Chlorhexidine mouthwash (0.2%); Other: Oxygen-based cleanser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline and end of each 1-month period (end of Period 1, Period 2, Period 3); 1-week washouts between periods.
Secondary outcomes (6)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and end of each 1-month period (end of Period 1, Period 2, Period 3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study startFeb 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Three 1-month periods in randomized sequence (ABC/BCA/CAB) with 1-week washouts between the groups. A = mechanical toothbrushing (fluoride toothpaste), B = chlorhexidine mouthwash, C = oxygen-based cleanser (BlueM). Algners changed every 10 days; water-only while aligners are in
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Elm University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faisal Ali Althobaiti, Riyadh Elm University
- Investigators
- Dr. Faisal A Althobaiti, BDS, Principal investigator, Riyadh Elm UniversityDr. Nancy M Ajwa, MSc, Study director, Riyadh Elm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307716
- Sponsor's protocol ID
- REU-ORTHO-ECOALIGN-XO-01
- Status last verified
- Jan 2026
- First submitted
- 15 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Heller D, Helmerhorst EJ, Gower AC, Siqueira WL, Paster BJ, Oppenheim FG. Microbial Diversity in the Early In Vivo-Formed Dental Biofilm. Appl Environ Microbiol. 2016 Jan 8;82(6):1881-8. doi: 10.1128/AEM.03984-15.
PubMed 26746720Zhao R, Huang R, Long H, Li Y, Gao M, Lai W. The dynamics of the oral microbiome and oral health among patients receiving clear aligner orthodontic treatment. Oral Dis. 2020 Mar;26(2):473-483. doi: 10.1111/odi.13175. Epub 2020 Jan 8.
PubMed 31418980Miguel YD, Alcântara PR, Toyofuku ACMM, Shimizu RH. Periodontal monitoring in orthodontic treatment with orthodontic aligners: proof of concept. Rev Odontol UNESP. 2024;53:e20240016. doi:10.1590/1807-2577.01624
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07307716
- Acronym / sponsor ID
- REU-ORTHO-ECOALIGN-XO-01
- Conditions
- Gingivitis, Dental Plaque
- Keywords
- Clear aligners, Chlorhexidine, BlueM, Oxygen-based cleanser, Mechanical toothbrushing, Supragingival plaque, Aligner biofilm, Fusobacterium nucleatum
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Riyadh Elm UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three 1-month periods in randomized sequence (ABC/BCA/CAB) with 1-week washouts between the groups. A = mechanical toothbrushing (fluoride toothpaste), B = chlorhexidine mouthwash, C = oxygen-based cleanser (BlueM). Algners changed every 10 days; water-only while aligners are in
| Arm | Type | Receives |
|---|---|---|
| Sequence ABC: Brushing then CHX Mouthwash then BlueM | Experimental | Behavioral: Mechanical toothbrushing (fluoride toothpaste), Drug: Chlorhexidine mouthwash (0.2%), Other: Oxygen-based cleanserParticipant 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. |
| Sequence BCA: CHX Mouthwash then BlueM then Brushing | Experimental | Behavioral: Mechanical toothbrushing (fluoride toothpaste), Drug: Chlorhexidine mouthwash (0.2%), Other: Oxygen-based cleanserParticipant 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. |
| Sequence CAB: BlueM then Brushing then CHX Mouthwash | Experimental | Behavioral: Mechanical toothbrushing (fluoride toothpaste), Drug: Chlorhexidine mouthwash (0.2%), Other: Oxygen-based cleanserParticipant 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical toothbrushing (fluoride toothpaste)Also: Colgate TotalControl 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. | Behavioural | Sequence ABC: Brushing then CHX Mouthwash then BlueM, Sequence BCA: CHX Mouthwash then BlueM then Brushing, Sequence CAB: BlueM then Brushing then CHX Mouthwash |
| Chlorhexidine mouthwash (0.2%)Also: CHXChlorhexidine 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. | Drug | Sequence ABC: Brushing then CHX Mouthwash then BlueM, Sequence BCA: CHX Mouthwash then BlueM then Brushing, Sequence CAB: BlueM then Brushing then CHX Mouthwash |
| Oxygen-based cleanserAlso: BlueMOxygen-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. | Other | Sequence ABC: Brushing then CHX Mouthwash then BlueM, Sequence BCA: CHX Mouthwash then BlueM then Brushing, Sequence CAB: BlueM then Brushing then CHX Mouthwash |
Primary outcome
Fusobacterium nucleatum CFU in supragingival plaque at the gingival margin (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.
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
Time frame: 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).
6 secondary outcomes
Prevotella intermedia CFU on retrieved aligner inner-surface biofilm
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)
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
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
Time frame: Baseline and end of each 1-month period (end of Period 1, Period 2, Period 3).
Gingival Index (GI) at index teeth
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
Time frame: Baseline and end of each 1-month period (end of Period 1, Period 2, Period 3).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Background: PubMed 26746720Heller D, Helmerhorst EJ, Gower AC, Siqueira WL, Paster BJ, Oppenheim FG. Microbial Diversity in the Early In Vivo-Formed Dental Biofilm. Appl Environ Microbiol. 2016 Jan 8;82(6):1881-8. doi: 10.1128/AEM.03984-15.
- Background: PubMed 31418980Zhao R, Huang R, Long H, Li Y, Gao M, Lai W. The dynamics of the oral microbiome and oral health among patients receiving clear aligner orthodontic treatment. Oral Dis. 2020 Mar;26(2):473-483. doi: 10.1111/odi.13175. Epub 2020 Jan 8.
- BackgroundMiguel YD, Alcântara PR, Toyofuku ACMM, Shimizu RH. Periodontal monitoring in orthodontic treatment with orthodontic aligners: proof of concept. Rev Odontol UNESP. 2024;53:e20240016. doi:10.1590/1807-2577.01624
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Faisal A Althobaiti, BDS principal investigator
Riyadh Elm University
Dr. Nancy M Ajwa, MSc study director
Riyadh Elm University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical toothbrushing (fluoride toothpaste), Chlorhexidine mouthwash (0.2%) and Oxygen-based cleanser in people with Gingivitis and Dental Plaque, run by Riyadh Elm University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Faisal A Althobaiti, BDS (+966594496974, faisal.althobaiti2024@student.riyadh.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusobacterium nucleatum CFU in supragingival plaque at the gingival margin (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07307716, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.