White Spot LesionsNCT07550179
Labial White Spot Lesions and Proximal Caries Development in Orthodontic Patients Using Clear Aligners Versus Traditional Braces.
A study testing Fixed pre-adjusted edgewise orthodontic appliance and Clear aligner therapy in people with White Spot Lesions and Proximal Caries, run by University of Sharjah at 1 site in United Arab Emirates.
Trial summary
This randomized clinical trial evaluates the risk of developing early tooth decay in patients undergoing orthodontic treatment with either traditional fixed braces or clear aligners. Read more about this study
- Who is it for?
- Ages 13 to 45 years
- Conditions the study is for
- White Spot Lesions, Proximal Caries, Oral Hygiene in Orthodontic Patients
- What is being tested?
- Fixed pre-adjusted edgewise orthodontic appliance and Clear aligner therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 8 Jan 2024to 27 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Demographics: Patients aged 13-45 years, possessing fully erupted permanent dentition (excluding third molars).
- Malocclusion Severity: Skeletal class I according to an ANB angle of 2-4 degrees (Steiner, 1953), moderate lower malalignment of 4-9 mm based on Little's Irregularity Index, and a class I incisor relationship (British Standards Institute, 1983).
- Treatment Protocol: Comprehensive, dual-arch orthodontic treatment strictly on a non-extraction basis.
- Handover form from their referring dentist confirming absence of caries requiring restorations and that all indicated restorative therapies have been completed, in addition to no active periodontal disease or pathologic probing depths.
- No prior history of orthodontic treatment.
- No full coverage restorations (crowns/veneers) on anterior teeth or premolars.
Who cannot join
- Inability to maintain adequate oral hygiene prior to treatment initiation.
- Dental Anomalies and Missing Teeth: Congenitally missing teeth, presence of dental implants, or impacted teeth (excluding third molars).
- Structural Enamel Defects: Presence of developmental enamel defects that mimic or obscure demineralization, including enamel hypoplasia, fluorosis, or amelogenesis imperfecta.
- Fluoride Supplementation: Patients currently utilizing a prescribed, daily supplemental fluoride regimen beyond standard over-the-counter fluoridated toothpaste.
- Adjunctive Appliances: Treatment plans requiring the use of plaque-retentive adjunct intraoral appliances (e.g., expanders, distalizers).
- Contraindications to Therapy: Any existing biological contraindications to comprehensive orthodontic tooth movement (e.g., advanced root resorption).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of White Spot Lesions and Proximal Caries During Orthodontic Treatment With Fixed Pre-adjusted Edgewise Appliances Versus Clear Aligners: A Pilot Randomized Clinical Trial
This randomized clinical trial evaluates the risk of developing early tooth decay in patients undergoing orthodontic treatment with either traditional fixed braces or clear aligners. Because orthodontic appliances can trap plaque and make tooth cleaning difficult, patients are at a higher risk for developing early decay, such as chalky "white spot lesions" on the visible surfaces of the teeth and hidden decay between the teeth (proximal caries).
In this six-month study, 24 participants are randomly assigned to receive either fixed braces or clear aligners. Researchers will monitor the participants' oral health prior to treatment, at 3 months, and at 6 months. To safely and accurately detect decay, the study uses standard visual examinations for the front of the teeth and a radiation-free optical scanner (Near-Infrared Imaging, or NIRI) to detect hidden cavities between the teeth.
The primary goal of this study is to compare how many new white spot lesions and hidden cavities between teeth develop in each group over the six-month observation period. Additionally, the study tracks how these early lesions behave over time, monitors changes in the patients' daily oral hygiene, and records how often patients in each group require professional dental cleaning procedures. Ultimately, this study aims to help patients and dental professionals make better-informed decisions regarding the specific cavity risks associated with each type of orthodontic appliance.
Read the detailed description
Background and Purpose While orthodontic treatments like traditional braces and clear aligners successfully straighten teeth, they introduce a significant challenge: they make it harder to keep teeth clean. Orthodontic appliances create new areas for dental plaque and bacteria to hide, which can rapidly lead to early tooth decay. This decay typically takes two forms: white spot lesions (WSLs), which are chalky, white marks that form on the visible front surfaces of the teeth, and proximal caries, which is hidden decay that develops in the tight spaces between adjacent teeth.
Historically, it was assumed that clear aligners were a "safer" alternative to braces regarding tooth decay because they can be removed for brushing and flossing. However, clear aligners cover the teeth for 22 hours a day, preventing natural saliva from washing away food and neutralizing acids. Because of this, the actual risk of developing both visible and hidden decay associated with the two treatments required rigorous investigation.
The primary purpose of this 6-month randomized clinical trial was to directly compare the risk, incidence, and behavior of early tooth decay in patients treated with conventional fixed braces versus those treated with clear aligners.
Study Design and Participants
This study was designed as a prospective, randomized clinical trial. A total of 24 eligible adult and adolescent participants who required orthodontic treatment were randomly assigned to one of two groups:
- Group 1: Fixed Appliances (traditional brackets and wires).
- Group 2: Clear Aligners (removable transparent trays). What Did the Researchers Measure?
To gain a complete picture of the patients' oral health, the research team tracked three major outcomes:
- Visible Decay (White Spot Lesions) and Lesion Behavior: Researchers visually examined the front surfaces of the teeth to detect new white spot lesions. Uniquely, the study did not just count the lesions at the end of treatment; it tracked their dynamic behavior. By evaluating the teeth at 3 months and 6 months, researchers could see exactly when a lesion formed and whether it worsened, stabilized, or healed (remineralized) over time.
- Hidden Decay (Proximal Caries) Using Advanced Optical Scanning: Detecting decay between the teeth usually requires X-rays, which expose patients to radiation and often miss the earliest stages of disease. To avoid unnecessary radiation and catch decay at its earliest optical phase, this study utilized Near-Infrared Imaging (NIRI). This cutting-edge, radiation-free scanner shines a safe, near-infrared light through the teeth (specifically focusing on the premolar teeth) to make hidden, early-stage decay glow brilliantly white on a digital screen.
- Oral Hygiene Burden and Professional Cleaning Procedures: The study tracked how difficult it was for patients to maintain their oral hygiene. Instead of just asking patients how well they brushed, the researchers objectively measured the "hygiene burden" by recording how often patients in each group required Professional Mechanical Plaque Removal (PMPR)-or professional dental cleaning-during their routine orthodontic visits.
Study Timeline
- Baseline (Start of Treatment): Patients received a thorough clinical examination, an assessment of their past cavity history, and a baseline NIRI optical scan to ensure no hidden decay was present before the appliances were placed.
- 3-Month Check: A visual examination was conducted specifically to catch the rapid, early onset of visible white spot lesions as patients adapted to their new appliances.
- 6-Month Check: A full examination was conducted, including a visual check for white spot lesions and a second NIRI optical scan to detect any new hidden decay that formed between the teeth over the first six months of treatment.
Why This Study Matters This study provides highly valuable, real-world evidence for both patients and healthcare providers. By demonstrating that neither appliance is completely cavity-free, it helps orthodontists provide highly accurate, evidence-based informed consent to their patients. It reveals that while clear aligners may protect the front of the teeth better and require fewer professional cleaning procedures, they still carry a significant risk for hidden decay between the teeth. Ultimately, this study emphasizes that regardless of the appliance chosen, highly personalized, strict oral hygiene routines are mandatory to protect the teeth during orthodontic treatment.
- Being tested
- Fixed pre-adjusted edgewise orthodontic appliance, Clear aligner therapy
- Keywords
- Clear aligners, Fixed orthodontic appliances, White spot lesions, Proximal caries, Enamel demineralization, Professional mechanical plaque removal, Intraoral scanner, Near-infrared imaging, Caries risk assessment, Past caries experience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed pre-adjusted edgewise orthodontic applianceDevice
Also called Fixed orthodontic appliance, Fixed labial braces, Conventional braces, Edgewise appliance
Participants in this group will be treated with pre-adjusted fixed orthodontic appliances (Master Series®, American Orthodontics™, WI, USA). This system includes fixed brackets bonded on the labial surface of teeth and a sequence of progressively larger arch wires aimed at achieving alignment over time.
Clear aligner therapyDevice
Also called Clear aligners, Clear aligner therapy (CAT), Eon aligner
Participants in this group will receive clear aligners (Eon Aligner, Minneapolis, USA), designed and customized based on a digital model of each patient's dental structure. Aligners will be worn for at least 22 hours daily, and patients will change to a new aligner depending on treatment progress.
| Study group | Role | What they receive |
|---|---|---|
| Fixed labial braces group | Active comparator | Participants in this group will be treated with pre-adjusted fixed orthodontic appliances. Receives: Device: Fixed pre-adjusted edgewise orthodontic appliance |
| Clear aligner group | Active comparator | Participants in this group will receive clear aligners customized based on a digital model of each patient's dentition. Receives: Device: Clear aligner therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of White Spot Lesions
The development of new (incident) white spot lesions on the labial surfaces of teeth during orthodontic treatment. Lesions are detected and classified using the visual International Caries Detection and Assessment System (ICDAS).
Measured: Up to 6 months (assessed 1 week before treatment at baseline, then 3 months and 6 months into treatment)
Incidence of Proximal Caries
The development of new caries lesions on the interproximal surfaces of teeth (specifically premolars). Detection is performed non-invasively using Near-Infrared Imaging (NIRI) technology via an intraoral scanner.
Measured: Baseline (1 week before treatment) and 6 months into treatment.
Secondary outcomes (3)
Behavior of Early Incident and Pre-existing White Spot Lesions
The dynamic changes (progression, regression, or stability) of white spot lesions over time. This tracks both lesions that were present prior to treatment and early incident lesions that formed within the first 3 months, evaluated using changes in their ICDAS codes.
Measured: Assessed at 3 months and 6 months.
Frequency of Professional Mechanical Plaque Removal (PMPR)
The cumulative frequency of reactive professional mechanical plaque removal (PMPR) required by participants due to inadequate at-home plaque control. This data is extracted from the institutional electronic health records.
Measured: Up to 6 months.
Change in Oral Hygiene Status
The changes in the participants' oral hygiene maintenance, evaluated clinically using a visual scale adapted from published literature.
Measured: Baseline and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start8 Jan 2024
- Primary completion27 Nov 2025
- Study completion27 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot LesionsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The interventional study model used in this study is a two-arm, parallel-group, randomized controlled trial (RCT) with a 1:1 allocation ratio between two treatment arms: clear aligners and fixed braces.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serene Adnan Badran, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550179
- Sponsor's protocol ID
- UoS-WSLPC-2024
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of White Spot Lesions and Proximal Caries During Orthodontic Treatment With Fixed Pre-adjusted Edgewise Appliances Versus Clear Aligners: A Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07550179
- Acronym / sponsor ID
- UoS-WSLPC-2024
- Keywords
- Clear aligners, Fixed orthodontic appliances, White spot lesions, Proximal caries, Enamel demineralization, Professional mechanical plaque removal, Intraoral scanner, Near-infrared imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 27 Nov 2025 (actual)
- Study completion
- 27 Nov 2025 (actual)
- First posted
- 24 Apr 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.
This randomized clinical trial evaluates the risk of developing early tooth decay in patients undergoing orthodontic treatment with either traditional fixed braces or clear aligners. Because orthodontic appliances can trap plaque and make tooth cleaning difficult, patients are at a higher risk for developing early decay, such as chalky "white spot lesions" on the visible surfaces of the teeth and hidden decay between the teeth (proximal caries).
In this six-month study, 24 participants are randomly assigned to receive either fixed braces or clear aligners. Researchers will monitor the participants' oral health prior to treatment, at 3 months, and at 6 months. To safely and accurately detect decay, the study uses standard visual examinations for the front of the teeth and a radiation-free optical scanner (Near-Infrared Imaging, or NIRI) to detect hidden cavities between the teeth.
The primary goal of this study is to compare how many new white spot lesions and hidden cavities between teeth develop in each group over the six-month observation period. Additionally, the study tracks how these early lesions behave over time, monitors changes in the patients' daily oral hygiene, and records how often patients in each group require professional dental cleaning procedures. Ultimately, this study aims to help patients and dental professionals make better-informed decisions regarding the specific cavity risks associated with each type of orthodontic appliance.
Detailed description
Background and Purpose While orthodontic treatments like traditional braces and clear aligners successfully straighten teeth, they introduce a significant challenge: they make it harder to keep teeth clean. Orthodontic appliances create new areas for dental plaque and bacteria to hide, which can rapidly lead to early tooth decay. This decay typically takes two forms: white spot lesions (WSLs), which are chalky, white marks that form on the visible front surfaces of the teeth, and proximal caries, which is hidden decay that develops in the tight spaces between adjacent teeth.
Historically, it was assumed that clear aligners were a "safer" alternative to braces regarding tooth decay because they can be removed for brushing and flossing. However, clear aligners cover the teeth for 22 hours a day, preventing natural saliva from washing away food and neutralizing acids. Because of this, the actual risk of developing both visible and hidden decay associated with the two treatments required rigorous investigation.
The primary purpose of this 6-month randomized clinical trial was to directly compare the risk, incidence, and behavior of early tooth decay in patients treated with conventional fixed braces versus those treated with clear aligners.
Study Design and Participants
This study was designed as a prospective, randomized clinical trial. A total of 24 eligible adult and adolescent participants who required orthodontic treatment were randomly assigned to one of two groups:
- Group 1: Fixed Appliances (traditional brackets and wires).
- Group 2: Clear Aligners (removable transparent trays). What Did the Researchers Measure?
To gain a complete picture of the patients' oral health, the research team tracked three major outcomes:
- Visible Decay (White Spot Lesions) and Lesion Behavior: Researchers visually examined the front surfaces of the teeth to detect new white spot lesions. Uniquely, the study did not just count the lesions at the end of treatment; it tracked their dynamic behavior. By evaluating the teeth at 3 months and 6 months, researchers could see exactly when a lesion formed and whether it worsened, stabilized, or healed (remineralized) over time.
- Hidden Decay (Proximal Caries) Using Advanced Optical Scanning: Detecting decay between the teeth usually requires X-rays, which expose patients to radiation and often miss the earliest stages of disease. To avoid unnecessary radiation and catch decay at its earliest optical phase, this study utilized Near-Infrared Imaging (NIRI). This cutting-edge, radiation-free scanner shines a safe, near-infrared light through the teeth (specifically focusing on the premolar teeth) to make hidden, early-stage decay glow brilliantly white on a digital screen.
- Oral Hygiene Burden and Professional Cleaning Procedures: The study tracked how difficult it was for patients to maintain their oral hygiene. Instead of just asking patients how well they brushed, the researchers objectively measured the "hygiene burden" by recording how often patients in each group required Professional Mechanical Plaque Removal (PMPR)-or professional dental cleaning-during their routine orthodontic visits.
Study Timeline
- Baseline (Start of Treatment): Patients received a thorough clinical examination, an assessment of their past cavity history, and a baseline NIRI optical scan to ensure no hidden decay was present before the appliances were placed.
- 3-Month Check: A visual examination was conducted specifically to catch the rapid, early onset of visible white spot lesions as patients adapted to their new appliances.
- 6-Month Check: A full examination was conducted, including a visual check for white spot lesions and a second NIRI optical scan to detect any new hidden decay that formed between the teeth over the first six months of treatment.
Why This Study Matters This study provides highly valuable, real-world evidence for both patients and healthcare providers. By demonstrating that neither appliance is completely cavity-free, it helps orthodontists provide highly accurate, evidence-based informed consent to their patients. It reveals that while clear aligners may protect the front of the teeth better and require fewer professional cleaning procedures, they still carry a significant risk for hidden decay between the teeth. Ultimately, this study emphasizes that regardless of the appliance chosen, highly personalized, strict oral hygiene routines are mandatory to protect the teeth during orthodontic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The interventional study model used in this study is a two-arm, parallel-group, randomized controlled trial (RCT) with a 1:1 allocation ratio between two treatment arms: clear aligners and fixed braces.
| Arm | Type | Receives |
|---|---|---|
| Fixed labial braces group | Active comparator | Device: Fixed pre-adjusted edgewise orthodontic applianceParticipants in this group will be treated with pre-adjusted fixed orthodontic appliances. |
| Clear aligner group | Active comparator | Device: Clear aligner therapyParticipants in this group will receive clear aligners customized based on a digital model of each patient's dentition. |
Who may qualify
- Ages
- 13 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Demographics: Patients aged 13-45 years, possessing fully erupted permanent dentition (excluding third molars).
- Malocclusion Severity: Skeletal class I according to an ANB angle of 2-4 degrees (Steiner, 1953), moderate lower malalignment of 4-9 mm based on Little's Irregularity Index, and a class I incisor relationship (British Standards Institute, 1983).
- Treatment Protocol: Comprehensive, dual-arch orthodontic treatment strictly on a non-extraction basis.
- Handover form from their referring dentist confirming absence of caries requiring restorations and that all indicated restorative therapies have been completed, in addition to no active periodontal disease or pathologic probing depths.
- No prior history of orthodontic treatment.
Key exclusion criteria (6 listed)
- Inability to maintain adequate oral hygiene prior to treatment initiation.
- Dental Anomalies and Missing Teeth: Congenitally missing teeth, presence of dental implants, or impacted teeth (excluding third molars).
- Structural Enamel Defects: Presence of developmental enamel defects that mimic or obscure demineralization, including enamel hypoplasia, fluorosis, or amelogenesis imperfecta.
- Fluoride Supplementation: Patients currently utilizing a prescribed, daily supplemental fluoride regimen beyond standard over-the-counter fluoridated toothpaste.
- Adjunctive Appliances: Treatment plans requiring the use of plaque-retentive adjunct intraoral appliances (e.g., expanders, distalizers).
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 pre-adjusted edgewise orthodontic applianceAlso: Fixed orthodontic appliance, Fixed labial braces, Conventional braces, Edgewise applianceParticipants in this group will be treated with pre-adjusted fixed orthodontic appliances (Master Series®, American Orthodontics™, WI, USA). This system includes fixed brackets bonded on the labial surface of teeth and a sequence of progressively larger arch wires aimed at achieving alignment over time. | Device | Fixed labial braces group |
| Clear aligner therapyAlso: Clear aligners, Clear aligner therapy (CAT), Eon alignerParticipants in this group will receive clear aligners (Eon Aligner, Minneapolis, USA), designed and customized based on a digital model of each patient's dental structure. Aligners will be worn for at least 22 hours daily, and patients will change to a new aligner depending on treatment progress. | Device | Clear aligner group |
Primary outcome
Incidence of White Spot Lesions
Time frame: Up to 6 months (assessed 1 week before treatment at baseline, then 3 months and 6 months into treatment)
The development of new (incident) white spot lesions on the labial surfaces of teeth during orthodontic treatment. Lesions are detected and classified using the visual International Caries Detection and Assessment System (ICDAS).
Incidence of Proximal Caries
Time frame: Baseline (1 week before treatment) and 6 months into treatment.
The development of new caries lesions on the interproximal surfaces of teeth (specifically premolars). Detection is performed non-invasively using Near-Infrared Imaging (NIRI) technology via an intraoral scanner.
3 secondary outcomes
Behavior of Early Incident and Pre-existing White Spot Lesions
Time frame: Assessed at 3 months and 6 months.
Frequency of Professional Mechanical Plaque Removal (PMPR)
Time frame: Up to 6 months.
Change in Oral Hygiene Status
Time frame: Baseline and 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 pre-adjusted edgewise orthodontic appliance and Clear aligner therapy in people with White Spot Lesions and Proximal Caries, run by University of Sharjah at 1 site in United Arab Emirates.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 30 Apr 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 United Arab Emirates. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of White Spot Lesions (time frame: Up to 6 months (assessed 1 week before treatment at baseline, then 3 months and 6 months into treatment)). 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?
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 30 Apr 2026.