Evaluate the Effect of Fluoride-Releasing Composite Resin on Prevention of White Spot Lesions During Clear Aligner Therapy

NCT07426432 | Active Not Recruiting

• 1 other identifier: Mansoura_ University
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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:
• Periodontal Ligament (PDL) Health
• Gingival Bleeding and Inflammation

Conditions

White Spot Lesions; Clear Aligner Appliance

Outcome Measures

Primary Outcomes (1)

• White Spot Lesions

  Incidence and Severity of White Spot Lesions Measured at baseline, third (T1) and sixth (T2) months, by Laser fluorescence (DIAGNOdent), lesion defined as having a numerical score equal to or higher than (14).

  six months

Secondary Outcomes (2)

• Periodontal Ligament (PDL) Health

  six months

• Gingival Bleeding and Inflammation

  six months

Study Arms (2)

Intervention Group (Experimental Side)

EXPERIMENTAL

application of fluoride-releasing composite on the indicated side of the mouth as attachments.

Other: Application of fluoride-releasing composite

Control Group (Control Side)

ACTIVE COMPARATOR

application of conventional composite as attachments.

Other: Application of conventional composite

Interventions

Application of fluoride-releasing composite OTHER

using fluoride releasing composite for attachment construction

Intervention Group (Experimental Side)

Application of conventional composite OTHER

using non fluoridated composite for attachment construction

Control Group (Control Side)

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 16-24 years.
• Good general and oral health.
• Mild dental crowding per arch (≤ 4 mm).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist Mohammed Amer

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: February 23, 2026
• Study Start: August 1, 2025
• Primary Completion: August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

EG (1)