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

NCT ID: NCT05550116

Last Updated: 2022-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-11

Study Completion Date

2022-10-11

Brief Summary

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

Detailed Description

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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.

Conditions

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White Spot Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Icon resin infiltration material

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

Group Type ACTIVE_COMPARATOR

Giomer

Intervention Type OTHER

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

Two composite resin sealants

Intervention Type OTHER

Unfilled composite resin sealants

PRG Barrier Coat

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

Group Type EXPERIMENTAL

Two composite resin sealants

Intervention Type OTHER

Unfilled composite resin sealants

Permaseal composite resin sealant

Permaseal unfilled composite resin sealants

Group Type EXPERIMENTAL

Giomer

Intervention Type OTHER

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

Optiguard

Optiguard unfilled composite resin sealant

Group Type EXPERIMENTAL

Giomer

Intervention Type OTHER

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

Interventions

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Giomer

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

Intervention Type OTHER

Two composite resin sealants

Unfilled composite resin sealants

Intervention Type OTHER

Other Intervention Names

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PRG Barrier Coat Permaseal and Optiguard

Eligibility Criteria

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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

* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Wakwak

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Khalid Noman, PROF

Role: STUDY_DIRECTOR

Alazhar Univerisity

Locations

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Mohamed Wakwak

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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2286488

Identifier Type: -

Identifier Source: org_study_id

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