Salivary Flow, pH, and Buffering Capacity in Fixed and Clear Aligner Orthodontic Treatment (NCT07397871) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Salivary Flow, pH, and Buffering Capacity in Fixed and Clear Aligner Orthodontic Treatment
Saudi Arabia40 participantsStarted 2026-03-15
Plain-language summary
Study Design: A randomized controlled trial with two parallel arms and an allocation ratio of 1:1.
Setting: The study will be conducted in the orthodontic department of Riyadh Elm University hospitals in Riyadh City, Saudi Arabia.
Participants: Patients undergoing fixed or clear aligner orthodontic treatment referred to REU dental hospital will be randomly allocated to either the clear aligner group or the fixed orthodontic appliance group.
Intervention: Prior to orthodontic treatment, all patients will receive phase I periodontal therapy and oral hygiene instructions. Fixed orthodontic appliances will be bonded using metallic brackets with a 0.022-inch slot and 0.014-inch NiTi archwires. Clear aligner patients will receive Invisalign® treatment.
Outcomes and Saliva Collection: Salivary samples will be collected using the spitting method at baseline (T0) and follow-up time points according to the study protocol. Salivary flow rate, pH, and buffering capacity will be assessed as described in the proposal.
Randomization and Blinding: Randomization will be performed using a random number generator with allocation concealment via opaque envelopes. The investigators involved in outcome assessment and data analysis will be blinded.
Ethical Considerations: The study will be submitted to the Institutional Review Board at Riyadh Elm University and conducted in accordance with IRB policies.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Class I, II and III skeletal malocclusion.
* Age ≥18 undergoing fixed or Clear aligner orthodontic treatment.
Exclusion Criteria:
* Current medications including antibiotic use within the past 3 months that affect salivary flow and composition.
* Active smoking including vaping and E-cigarette use.
* Diagnosis of systemic diseases/conditions such as Sjogren's syndrome, diabetes, chronic kidney diseases, neurological conditions.
* Active dental caries or signs of gingivitis and/or periodontitis
* Less than three months of orthodontic treatment since it is characterized by acute, temporary changes and patient adaptation to the new appliances.
* Requiring single arch treatment to standardize the research and eliminate a potential confounding variable
* Crown restoration is excluded due to their material properties which may affect salivary composition.
* Pregnancy due to the physiological variation in salivary flow and composition due to hormonal changes.
* Presence of mouth breathing may lead to inconsistent salivary flow rate, Changes in Salivary Composition and pH
* Poor oral hygiene with high levels of dental plaque, calculus, and gingival inflammation can independently alter salivary flow rate, pH, and buffer capacity there by acting as confounding variable.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Salivary flow rate
Timeframe: The outcome measure will be assessed at (T0) just before the commencement of fixed appliance and Clear Aligner therapy, at one week (T1), at two weeks (T2), after three months (T3), and at six months (T4) of treatment.