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Status unknownNCT05550116Updated Sep 26, 2022

Clinical Evaluation of White Spot Lesions Treated by S-PRG and ICON

An interventional study of Giomer and Two composite resin sealants in White Spot Lesion, sponsored by Al-Azhar University. Status unknown at 1 site in Egypt. Open to participants aged 19 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-26.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
19 Years to 40 Years
Sex
All
01

Study summary

Randomized with (1:1) prospective, double-blind, controlled trial. Subjects will be randomized to receive S-PRG and the control group receives ICON.

Read the detailed description

Interventions: - All the procedures will be performed by the same clinician. DIAGNOdent will be used to assess the fluorescence loss of WSLs and the adjacent sound enamel. WSLs in permanent teeth will be treated according to the manufacturer's instructions with:

  • Group I (Control group): 20 teeth will be treated with ICON.
  • Group II ( EXPERIMENTAL) : 20 teeth will be treated with PRG BarrierCoat.

Observation: - The treatment methods will be assessed immediately after the intervention, 3 months,6 months, and one year. The data will be collected for evaluation of the difference in color and fluorescence loss between the treatment groups, by using DIAGNOdent devices, over different time intervals.

Ethical considerations: The research protocol is approved by the ethical committee, Faculty of Dental Medicine, Al-Azhar University and the enrolled patients should sign a written consent form.

02

Conditions studied

  • White Spot Lesion

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Keywords

  • white spot lesions
  • ICON
  • S-PRG
  • DIAGNOdent
03

Who can participate

Ages eligible
19 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients within 20-40 years of age.
  • Each patient has 4 or more WSLs.
  • Mild and moderate WSLs according to Gorelick's scale.
  • Good oral hygiene and willing patients who can attend the study visits.
  • a Symmetrical number of permanent teeth in each arch (mesial to second molars).

Exclusion criteria

Exclusion Criteria:

  • Active carious lesions.
  • Facial surface restorations.
  • Intrinsic and extrinsic stains.
  • Patients who have a significant medical history or if they smoke.
  • Criteria for discontinuation; Mortality and acquiring severe debilitating disease
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Icon resin infiltration material

    Smooth surface resin infiltration comprises three steps for resin infiltration; Icon etch, Icon dry, and Icon infiltrant

    Other: Giomer · Other: Two composite resin sealants

  • Experimental
    PRG Barrier Coat

    fluoride-releasing coating material containing surface reaction-type pre-reacted glass-ionomer (S-PRG) fillers

    Other: Two composite resin sealants

  • Experimental
    Permaseal composite resin sealant

    Permaseal unfilled composite resin sealants

    Other: Giomer

  • Experimental
    Optiguard

    Optiguard unfilled composite resin sealant

    Other: Giomer

Interventions

  • OtherGiomer

    fluoride-releasing coating material containing surface reaction-type pre-reacted glass-ionomer (S-PRG) fillers

    Also known as: PRG Barrier Coat

  • OtherTwo composite resin sealants

    Unfilled composite resin sealants

    Also known as: Permaseal and Optiguard

05

What researchers measure

Primary outcomes

  1. patients tooth color change

    Color change with Vita Easyshade When the Delta E increased, it consider esthetic improving

    Time frame: 1 year

Secondary outcomes

  1. patients tooth caries lesion state

    Laser fluorescence score Assessing of carious lesions state of the lesions by Diagnodent Minimum score is 0, while maximum score is 20 When score is decreased it consider positive results

    Time frame: 1 year

06

Study locations

1 site
  • Mohamed Wakwak
    Cairo, 11768, Egypt
07

Registry details

Key details

Study ID
NCT05550116
Lead sponsor
Al-Azhar University
Responsible party
Mohamed Wakwak (Assistant professor, Al-Azhar University) — Principal investigator
First posted
Sep 22, 2022
Start date
Aug 11, 2021
Primary completion
Aug 30, 2022
Completion
Oct 11, 2022 (estimated)
Last update
Sep 26, 2022

Study contacts

Khalid Noman, PROF
study director · Alazhar Univerisity

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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