search
Back to results

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

Primary Purpose

White Spot Lesion

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Giomer
Two composite resin sealants
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for White Spot Lesion focused on measuring white spot lesions, ICON, S-PRG, DIAGNOdent

Eligibility Criteria

19 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mohamed Wakwak

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Icon resin infiltration material

PRG Barrier Coat

Permaseal composite resin sealant

Optiguard

Arm Description

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

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

Permaseal unfilled composite resin sealants

Optiguard unfilled composite resin sealant

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 19, 2022
Last Updated
September 22, 2022
Sponsor
Al-Azhar University
search

1. Study Identification

Unique Protocol Identification Number
NCT05550116
Brief Title
Clinical Evaluation of White Spot Lesions Treated by S-PRG and ICON
Official Title
Clinical Evaluation of White Spot Lesions Treated by S-PRG Coating Material and Resin Sealants in Comparison With Resin Infiltration by Using Spectrophotometer and Laser Fluorescence. (A Randomized Controlled Trial) (WSLs)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
October 11, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
White Spot Lesion
Keywords
white spot lesions, ICON, S-PRG, DIAGNOdent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Icon resin infiltration material
Arm Type
Active Comparator
Arm Description
Smooth surface resin infiltration comprises three steps for resin infiltration; Icon etch, Icon dry, and Icon infiltrant
Arm Title
PRG Barrier Coat
Arm Type
Experimental
Arm Description
fluoride-releasing coating material containing surface reaction-type pre-reacted glass-ionomer (S-PRG) fillers
Arm Title
Permaseal composite resin sealant
Arm Type
Experimental
Arm Description
Permaseal unfilled composite resin sealants
Arm Title
Optiguard
Arm Type
Experimental
Arm Description
Optiguard unfilled composite resin sealant
Intervention Type
Other
Intervention Name(s)
Giomer
Other Intervention Name(s)
PRG Barrier Coat
Intervention Description
fluoride-releasing coating material containing surface reaction-type pre-reacted glass-ionomer (S-PRG) fillers
Intervention Type
Other
Intervention Name(s)
Two composite resin sealants
Other Intervention Name(s)
Permaseal and Optiguard
Intervention Description
Unfilled composite resin sealants
Primary Outcome Measure Information:
Title
patients tooth color change
Description
Color change with Vita Easyshade When the Delta E increased, it consider esthetic improving
Time Frame
1 year
Secondary Outcome Measure Information:
Title
patients tooth caries lesion state
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalid Noman, PROF
Organizational Affiliation
Alazhar Univerisity
Official's Role
Study Director
Facility Information:
Facility Name
Mohamed Wakwak
City
Cairo
ZIP/Postal Code
11768
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs