Orthodontic TreatmentNCT07397871
Salivary Flow, pH, and Buffering Capacity in Fixed and Clear Aligner Orthodontic Treatment
A study testing Fixed orthodontic appliances and Clear Aligner Treatment in people with Orthodontic Treatment and Saliva, run by Riyadh Elm University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthodontic Treatment, Saliva
- What is being tested?
- Fixed orthodontic appliances and Clear Aligner Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Sep 2026to Jun 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Class I, II and III skeletal malocclusion.
- Age ≥18 undergoing fixed or Clear aligner orthodontic treatment.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Changes in Salivary Parameters in Patients Undergoing Clear Aligner Orthodontic Treatment: A Randomized Controlled 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.
Read more
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.
Read the detailed description
This study is a randomized controlled clinical trial designed to evaluate changes in salivary parameters in patients undergoing fixed orthodontic treatment or clear aligner therapy. Patients referred to the orthodontic department of Riyadh Elm University dental hospital will be screened for eligibility and randomly allocated into two parallel groups with an allocation ratio of 1:1.
Prior to the initiation of orthodontic treatment, all participants will undergo phase I periodontal therapy and receive standardized oral hygiene instructions. Patients in the fixed orthodontic appliance group will be treated using metallic brackets with a 0.022-inch slot and initial 0.014-inch nickel-titanium archwires. Patients in the clear aligner group will receive clear aligner treatment according to the prescribed protocol.
Salivary samples will be collected using the spitting method at baseline before the start of orthodontic treatment (T0) and at subsequent follow-up time points as specified in the study protocol. Salivary flow rate, salivary pH, and buffering capacity will be assessed at each time point using standardized methods described in the proposal.
Randomization will be carried out using a random number generator, with allocation concealment ensured through the use of opaque sealed envelopes. The investigators involved in outcome assessment and data analysis will be blinded to group allocation.
This study will be conducted following approval from the Institutional Review Board (IRB) of Riyadh Elm University and in accordance with institutional ethical guidelines.
- Conditions
- Orthodontic Treatment, Saliva
- Being tested
- Fixed orthodontic appliances, Clear Aligner Treatment
- Keywords
- Salivary flow, Salivary pH, Buffering capacity, Fixed orthodontic appliance, Clear aligner therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed orthodontic appliancesDevice
Study subjects in control group will receive fixed orthodontic appliances with metallic brackets of 0.022-inch slot size (American Orthodontics).
Clear Aligner TreatmentDevice
Study 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.
| Study group | Role | What they receive |
|---|---|---|
| Fixed orthodontic treatment control group | Active comparator | Study subjects in control group will receive fixed orthodontic appliances with metallic brackets of 0.022-inch slot size (American Orthodontics). The bonding process will be performed using the same adhesive (BracePaste, American Orthodontics) for all patients, and treatment will be initiated with 0.014-inch NiTi archwires (Highland Metals). Receives: Device: Fixed orthodontic appliances |
| Clear Aligner Treatment Group | Experimental | Study 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. Receives: Device: Clear Aligner Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (2)
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (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 Orthodontic TreatmentStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A non-inferiority randomized controlled trial with two parallel arms and an allocation ratio of 1:1.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Elm University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Alkadhi, Riyadh Elm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397871
- Sponsor's protocol ID
- REU-CA-SALIVA-RCT-001
- Status last verified
- Aug 2026
- First submitted
- 2 Feb 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Arab S, Nouhzadeh Malekshah S, Abouei Mehrizi E, Ebrahimi Khanghah A, Naseh R, Imani MM. Effect of Fixed Orthodontic Treatment on Salivary Flow, pH and Microbial Count. J Dent (Tehran). 2016 Jan;13(1):18-22.
PubMed 27536324Leone CW, Oppenheim FG. Physical and chemical aspects of saliva as indicators of risk for dental caries in humans. J Dent Educ. 2001 Oct;65(10):1054-62.
PubMed 11699977Alshahrani I, Hameed MS, Syed S, Amanullah M, Togoo RA, Kaleem S. Changes in essential salivary parameters in patients undergoing fixed orthodontic treatment: A longitudinal study. Niger J Clin Pract. 2019 May;22(5):707-712. doi: 10.4103/njcp.njcp_606_18.
PubMed 31089027
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Salivary Parameters in Patients Undergoing Clear Aligner Orthodontic Treatment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07397871
- Acronym / sponsor ID
- REU-CA-SALIVA-RCT-001
- Conditions
- Orthodontic Treatment, Saliva
- Keywords
- Salivary flow, Salivary pH, Buffering capacity, Fixed orthodontic appliance, Clear aligner therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riyadh Elm UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Feb 2026 (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.
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.
Detailed description
This study is a randomized controlled clinical trial designed to evaluate changes in salivary parameters in patients undergoing fixed orthodontic treatment or clear aligner therapy. Patients referred to the orthodontic department of Riyadh Elm University dental hospital will be screened for eligibility and randomly allocated into two parallel groups with an allocation ratio of 1:1.
Prior to the initiation of orthodontic treatment, all participants will undergo phase I periodontal therapy and receive standardized oral hygiene instructions. Patients in the fixed orthodontic appliance group will be treated using metallic brackets with a 0.022-inch slot and initial 0.014-inch nickel-titanium archwires. Patients in the clear aligner group will receive clear aligner treatment according to the prescribed protocol.
Salivary samples will be collected using the spitting method at baseline before the start of orthodontic treatment (T0) and at subsequent follow-up time points as specified in the study protocol. Salivary flow rate, salivary pH, and buffering capacity will be assessed at each time point using standardized methods described in the proposal.
Randomization will be carried out using a random number generator, with allocation concealment ensured through the use of opaque sealed envelopes. The investigators involved in outcome assessment and data analysis will be blinded to group allocation.
This study will be conducted following approval from the Institutional Review Board (IRB) of Riyadh Elm University and in accordance with institutional ethical guidelines.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A non-inferiority randomized controlled trial with two parallel arms and an allocation ratio of 1:1.
| Arm | Type | Receives |
|---|---|---|
| Fixed orthodontic treatment control group | Active comparator | Device: Fixed orthodontic appliancesStudy subjects in control group will receive fixed orthodontic appliances with metallic brackets of 0.022-inch slot size (American Orthodontics). The bonding process will be performed using the same adhesive (BracePaste, American Orthodontics) for all patients, and treatment will be initiated with 0.014-inch NiTi archwires (Highland Metals). |
| Clear Aligner Treatment Group | Experimental | Device: Clear Aligner TreatmentStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Class I, II and III skeletal malocclusion.
- Age ≥18 undergoing fixed or Clear aligner orthodontic treatment.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| Fixed orthodontic appliancesStudy subjects in control group will receive fixed orthodontic appliances with metallic brackets of 0.022-inch slot size (American Orthodontics). | Device | Fixed orthodontic treatment control group |
| Clear Aligner TreatmentStudy 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. | Device | Clear Aligner Treatment Group |
Primary outcome
Salivary flow rate
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.
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.
2 secondary outcomes
Salivary pH
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.
Salivary buffering capacity
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.
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 9 Sep 2026.
- Background: PubMed 27536324Arab S, Nouhzadeh Malekshah S, Abouei Mehrizi E, Ebrahimi Khanghah A, Naseh R, Imani MM. Effect of Fixed Orthodontic Treatment on Salivary Flow, pH and Microbial Count. J Dent (Tehran). 2016 Jan;13(1):18-22.
- Background: PubMed 11699977Leone CW, Oppenheim FG. Physical and chemical aspects of saliva as indicators of risk for dental caries in humans. J Dent Educ. 2001 Oct;65(10):1054-62.
- Background: PubMed 31089027Alshahrani I, Hameed MS, Syed S, Amanullah M, Togoo RA, Kaleem S. Changes in essential salivary parameters in patients undergoing fixed orthodontic treatment: A longitudinal study. Niger J Clin Pract. 2019 May;22(5):707-712. doi: 10.4103/njcp.njcp_606_18.
- Arab S, Nouhzadeh Malekshah S, Abouei Mehrizi E, et al. (2016) Effect of Fixed Orthodontic Treatment on Salivary Flow, pH and Microbial Count. Journal of Dentistry (Tehran, Iran) 13(1): 18-22. Razan'S Alsalamah Proposal 3-To…Link provided by the sponsor.
- Dawes C (2003) What is the critical pH and why does a tooth dissolve in acid? Journal (Canadian Dental Association) 69(11): 722-724.Link provided by the sponsor.
- Leone CW and Oppenheim FG (2001) Physical and chemical aspects of saliva as indicators of risk for dental caries in humans. Journal of Dental Education 65(10): 1054-1062.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed orthodontic appliances and Clear Aligner Treatment in people with Orthodontic Treatment and Saliva, 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 2 inclusion and 10 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 9 Sep 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 Razan Musaad Alsalamah (00966553771240, razan.alsalamah2024@student.riyadh.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary flow rate (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.). 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 NCT07397871, 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 9 Sep 2026; AzTrials last refreshed its copy on 4 Nov 2026.