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

July 16, 2026 updated by: Jordan University of Science and Technology

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Irbid, Jordan, 22110
        • Postgraduate Orthodontic Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bioactive resin Composite containing S-PRG filler
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
Bioactive resin composite containing S-PRG filler is used as attachment material for the orthodontic clear aligners
Placebo Comparator: Conventional flowable composite
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 is used for the attachments for the clear orthodontic aligners

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
White spot lesion area
Time Frame: 6 months
It measures the area of enamel demineralization (in pixels) using QLF system
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordan University of Science and Technology

Collaborators

Jordan University of Science and Technology/Deanship of Scientific Research

Investigators

  • Study Director: Susan Al-Khateeb, Jordan University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2025

Primary Completion (Estimated)

August 20, 2026

Study Completion (Estimated)

December 23, 2026

Study Registration Dates

First Submitted

July 7, 2026

First Submitted That Met QC Criteria

July 16, 2026

First Posted (Actual)

July 21, 2026

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 16, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JUST20250049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be shared upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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