NCT07602660

Brief Summary

This randomized controlled trial is held to investigate the effectiveness of two remineralizing agents surface pre-reacted glass-ionomer (S-PRG) filler and fluoride in management of white spot lesions.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 16, 2026

Last Update Submit

May 16, 2026

Conditions

White Spot Lesion

Outcome Measures

Primary Outcomes (1)

  • Patients tooth caries lesion state

    FDI Criteria (Visual examination of active caries lesion)

    6 months

Secondary Outcomes (1)

  • Patients' tooth color change

    6 months

Study Arms (2)

S-PRG barrier coat

EXPERIMENTAL

varnish containing Surface pre-reacted glass-ionomer technology

Other: S-PRG barrier coat

Profluorid Varnish

ACTIVE COMPARATOR

Fluoride varnish

Other: Profluorid Varnish

Interventions

S-PRG barrier coatOTHER

varnish containing Surface pre-reacted glass-ionomer technology

S-PRG barrier coat
Profluorid VarnishOTHER

Fluoride varnish

Profluorid Varnish

Eligibility Criteria

Age16 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients within 16-35 years of age.
  • Each patient has 4 or more WSLs
  • Mild and moderate WSLs.
  • Good oral hygiene and willing patients who can attend study visits.
  • Symmetrical number of permanent teeth in each arch (mesial to second molars).

You may not qualify if:

  • Active carious lesions.
  • Labial surface restorations.
  • Intrinsic and extrinsic stains.
  • Patients who have a significant medical history or if they are smokers.
  • Patients who participated in clinical study during the preceding six months of the start of this trial.
  • Criteria for discontinuation; Mortality and acquiring severe debilitating disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's degree Student

Study Record Dates

First Submitted

May 16, 2026

First Posted

May 22, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05