NCT07397871

Salivary Flow, pH, and Buffering Capacity in Fixed and Clear Aligner Orthodontic Treatment

Changes in Salivary Parameters in Patients Undergoing Clear Aligner Orthodontic Treatment: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Riyadh Elm University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Fixed orthodontic appliances	Study subjects in control group will receive fixed orthodontic appliances with metallic brackets of 0.022-inch slot size (American Orthodontics).
DEVICE	Clear Aligner Treatment	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.

Timeline

• Start date: 2026-03-15
• Primary completion: 2027-02-15
• Completion: 2027-05-29
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: Saudi Arabia