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NCT Number: NCT07715942

Effect of Bioactive Resin Material Containing S-PRG Filler on White Spot Lesions

the effect of bioactive resin composite containing S-PRG filler will be tested as the material of choice for attachments bonded on teeth prior to the use of orthodontic clear aligners compared to the conventionally used flowable composite material for the prevention of white spot lesions on enamel tooth surfaces

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

White Spot Lesion of Tooth

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Postgraduate Orthodontic Clinics

Irbid, 22110, Jordan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy young adult orthodontic patients
  • Class 1 malocclusion with mild to moderate crowding (<6 mm).
  • Non extraction treatment plan.
  • Optimum oral Hygiene before treatment.
  • A maximum of three restored teeth with either fillings or prosthesis.

Exclusion criteria

  • Patients with defective enamel, fluorosis, hypocalcification or enamel hypoplasia.
  • Extensive restorations.
  • Syndromes and Oro-facial anomalies.
  • Salivary gland diseases.
  • Patients who are pregnant, diabetic, or using mouth rinses or interacting medications, including antibiotic therapy.

Treatment and study plan

Bioactive resin composite containing S-PRG filler

Other

Bioactive resin composite containing S-PRG filler is used as attachment material for the orthodontic clear aligners

Conventional flowable composite is used for the attachments for the clear orthodontic aligners

Other

Conventional flowable composite is used for the attachments for the clear orthodontic aligners

Primary outcomes

  1. White spot lesion area

    Time frame: 6 months

    It measures the area of enamel demineralization (in pixels) using QLF system

  2. Mean of fluorescence loss (Delta F)

    Time frame: 6 months

    It measures the percentage of fluorescence loss in the white spot lesion compared to that of sound reflecting the amount of mineral loss using QLF system

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Collaborators

  • Jordan University of Science and Technology/Deanship of Scientific Research

Registry information

Official study title

Effect of Bioactive Resin Material Containing S-PRG Filler on White Spot Lesions: A Randomized Controlled Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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