Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:20 AM
Study NCT ID:
NCT07426432
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2025-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Effect of Fluoride-Releasing Composite Resin on Prevention of White Spot Lesions During Clear Aligner Therapy
Sponsor:
Mansoura University
Organization:
Study Overview
Official Title:
Evaluate the Effect of Fluoride-Releasing Composite Resin on Prevention of White Spot Lesions During Clear Aligner Therapy: A Controlled Split-Mouth Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim of this study: evaluate the effect of fluoride-releasing composite resin as attachments on prevention of white spot lesions.
Material and methods:
Type: Prospective, randomized split mouth controlled study.
Interventions:
Intervention Group (Experimental Side):
•Application of fluoride-releasing composite
Control Group (Control Side):
•Application of conventional composite
Outcome Measures:
Primary Outcome: Incidence and Severity of White Spot Lesions
Secondary Outcomes:
1. Periodontal Ligament (PDL) Health
2. Gingival Bleeding and Inflammation
Material and methods:
Type: Prospective, randomized split mouth controlled study.
Interventions:
Intervention Group (Experimental Side):
•Application of fluoride-releasing composite
Control Group (Control Side):
•Application of conventional composite
Outcome Measures:
Primary Outcome: Incidence and Severity of White Spot Lesions
Secondary Outcomes:
1. Periodontal Ligament (PDL) Health
2. Gingival Bleeding and Inflammation
Detailed Description:
Aim of the Study:
The aim of this study is to evaluate the effect of fluoride-releasing composite resin as attachments on prevention of white spot lesions (WSLs) development during clear aligner therapy in comparison to a split-mouth controlled group.
Material and methods:
Study Design:
Each participant will have one side of the mouth assigned to fluoride-releasing composite intervention as attachments, while the contralateral side will be assigned to conventional composite as attachments.
Sample size calculation:
Sample size calculation was based on effect of fluoride-releasing composite resin on prevention of White Spot Lesions during Clear Aligner Therapy: that was retrieved from most similar research Abdullah et al. Using G power program version 3.1.9.7 to calculate sample size based on effect size of 1.08 that is based on mean area of white spots, using 2-tailed test, α error = 0.05 and power = 95% , the total calculated sample size will be 24 in each group. To mitigate the potential impact of an anticipated 20% dropout rate, the recruitment target was increased to 30 patients per treatment group, aiming to ensure adequate statistical power in the final analyzed sample.
Inclusion Criteria:
* Patients aged 16-24 years.
* Good general and oral health.
* Mild dental crowding per arch (≤ 4 mm).
Exclusion Criteria:
* Systemic conditions affecting tooth movement (e.g., diabetes, bone disorders).
* Patients with Cleft lip and palate.
* Previous orthodontic treatment.
* Dental fluorosis.
* Hypocalcified teeth or visible demineralization.
Interventions:
1. Initial Oral Scan:
A 3D oral scan of the arch to be treated will be performed using a digital intraoral scanner
2. Aligner Fabrication:
Aligners will be fabricated using thermoforming techniques. Intervention Group (Experimental Side): application of a fluoride-releasing composite on the indicated side of the mouth as attachments.
Control Group (Control Side): application of conventional composite as attachments.
3. Aligner Placement: the aligners will be fitted, and patients will wear them continuously, except during eating and brushing.
Outcome Measures:
Primary Outcome: Incidence and Severity of White Spot Lesions Measured at base line, third (T1) and sixth (T2) months.
1.Laser fluorescence (DIAGNOdent), lesion defined as having a numerical score equal to or higher than (14).
Secondary Outcome:
1. Periodontal Ligament (PDL) Health using: Pocket Depth Index (PDI)
2. Gingival Bleeding and Inflammation
Duration of the study:
•This study is suggested to be finished in 12 months.
The aim of this study is to evaluate the effect of fluoride-releasing composite resin as attachments on prevention of white spot lesions (WSLs) development during clear aligner therapy in comparison to a split-mouth controlled group.
Material and methods:
Study Design:
Each participant will have one side of the mouth assigned to fluoride-releasing composite intervention as attachments, while the contralateral side will be assigned to conventional composite as attachments.
Sample size calculation:
Sample size calculation was based on effect of fluoride-releasing composite resin on prevention of White Spot Lesions during Clear Aligner Therapy: that was retrieved from most similar research Abdullah et al. Using G power program version 3.1.9.7 to calculate sample size based on effect size of 1.08 that is based on mean area of white spots, using 2-tailed test, α error = 0.05 and power = 95% , the total calculated sample size will be 24 in each group. To mitigate the potential impact of an anticipated 20% dropout rate, the recruitment target was increased to 30 patients per treatment group, aiming to ensure adequate statistical power in the final analyzed sample.
Inclusion Criteria:
* Patients aged 16-24 years.
* Good general and oral health.
* Mild dental crowding per arch (≤ 4 mm).
Exclusion Criteria:
* Systemic conditions affecting tooth movement (e.g., diabetes, bone disorders).
* Patients with Cleft lip and palate.
* Previous orthodontic treatment.
* Dental fluorosis.
* Hypocalcified teeth or visible demineralization.
Interventions:
1. Initial Oral Scan:
A 3D oral scan of the arch to be treated will be performed using a digital intraoral scanner
2. Aligner Fabrication:
Aligners will be fabricated using thermoforming techniques. Intervention Group (Experimental Side): application of a fluoride-releasing composite on the indicated side of the mouth as attachments.
Control Group (Control Side): application of conventional composite as attachments.
3. Aligner Placement: the aligners will be fitted, and patients will wear them continuously, except during eating and brushing.
Outcome Measures:
Primary Outcome: Incidence and Severity of White Spot Lesions Measured at base line, third (T1) and sixth (T2) months.
1.Laser fluorescence (DIAGNOdent), lesion defined as having a numerical score equal to or higher than (14).
Secondary Outcome:
1. Periodontal Ligament (PDL) Health using: Pocket Depth Index (PDI)
2. Gingival Bleeding and Inflammation
Duration of the study:
•This study is suggested to be finished in 12 months.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: