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

NCT07715942 | Active Not Recruiting DMC

• 1 other identifier: JUST20250049
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

White Spot Lesion of Tooth

Keywords

Clear aligners, Bioactive resin, Composite containing S-PRG filler, QLF; Clear aligners; Bioactive resin; Composite containing S-PRG filler; Quantitative Light-Induced Fluorescence (QLF)

Outcome Measures

Primary Outcomes (2)

• White spot lesion area

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

  6 months

• Mean of fluorescence loss (Delta F)

  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

  6 months

Study Arms (2)

Bioactive resin Composite containing S-PRG filler

EXPERIMENTAL

Bioactive resin Composite containing S-PRG filler is used for the attachments for the clear orthodontic aligners

Other: Bioactive resin composite containing S-PRG filler

Conventional flowable composite

PLACEBO COMPARATOR

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

Interventions

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

Bioactive resin Composite containing S-PRG filler

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

Conventional flowable composite

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jordan University of Science and Technology: lead
• Jordan University of Science and Technology/Deanship of Scientific Research: collaborator

Study Sites (1)

Postgraduate Orthodontic Clinics

Irbid, 22110, Jordan

Location

Study Officials

• Susan Al-Khateeb

  Jordan University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 21, 2026
• Study Start: July 13, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): December 23, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)