Salivary Flow, pH, and Buffering Capacity in Fixed and Clear Aligner Orthodontic Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRiyadh Elm University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Class I, II and III skeletal malocclusion.
Age ≥18 undergoing fixed or Clear aligner orthodontic treatment.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Fixed orthodontic appliances
DeviceStudy subjects in control group will receive fixed orthodontic appliances with metallic brackets of 0.022-inch slot size (American Orthodontics).
Clear Aligner Treatment
DeviceStudy subjects in Clear Aligner treatment group will receive Invisalign® (Align Technology, Inc., Tempe, AZ, USA). The Clear Aligner treatment protocol will be followed until the end of the treatment.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Fixed orthodontic treatment control groupActive comparator 1 intervention
Group B: Clear Aligner Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Salivary flow rate
The salivary flow rate will be recorded in each patient. Two mL of whole unstimulated saliva will be collected in a graduated tube. The salivary flow rate will be recorded in all the four time points T0, T1, T3 and T4.
Time frame
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.Secondary outcomes
1
Salivary pH
The pH values will be assessed using portable pH meter strips at the same four time points. Salivary pH will be measured at T0, T1, T3 and T4.
Time frame
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.2
Salivary buffering capacity
Buffer capacity will be determined by quantitative test using a hand-held pH meter method. This method will involve addition of 0.5 ml of saliva to 1.5 ml of 5 mmol/L HCl. Mixtures will be vigorously shaken. Then stream of Nitrogen will be passed through the mixture for 20 min to eliminate carbon dioxide from the sample and allowed to stand for 10 min when the final pH will be measured. The salivary buffering capacity will be measured at T0, T1, T3 and T4.
Time frame
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.Sponsors and contacts
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Source ClinicalTrials.gov
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