Clinical Evaluation of White Spot Lesions Treated by S-PRG Material and Composite Sealants in Comparison With ICON

Clinical Evaluation of White Spot Lesions Treated by Surface Pre-reacted Glass Filler Coating Material and Composite Sealants in Comparison With Icon Resin Infiltration by Using Laser Fluorescence and Spectrophotometer

Dental caries is the primary cause of tooth loss and oral diseases. Dental decay is a continuous pathological process with loss of tooth minerals, demineralization, which involves the destruction of tooth structure from acids. The first sign of early active demineralization is white spot lesions (WSLs) on the tooth surface, meanwhile, subsurface active mineral decomposition.

Study Overview

• Status: Completed
• Conditions: White Spot Lesions
• Intervention / Treatment: Combination product: surface pre-reacted glass filler coating material

Detailed Description

Deposition of minerals depends on the equilibrium between demineralization and remineralization which may happen as a natural repair mechanism. The aim of this trial is to comparatively evaluate the efficacy of surface pre-reacted glass filler (S-PRG) Barrier Coat coating material against the Icon resin infiltration in the ability to improve the caries lesion state of the WSLs along 1 year. Laser fluorescence was used to compare the two materials to evaluate the caries progression. PRG Barrier Coat group showed immediate significant improvement in LF scores in demineralization progress and inhibition of caries progression with a significant improved effect. S-PRG Barrier Coat was clinically successful strategy in inhibition of caries and improve remineralization.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11768
    • Mohamed Wakwak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: surface pre-reacted glass filler coating material; surface pre-reacted glass filler coating material used to remineralize WSLs	Combination product: surface pre-reacted glass filler coating material; the ability to improve the aesthetic appearance (masking) and caries lesion state of the WSLs
Active Comparator: micro-invasive resin infiltration technique (Icon); micro-invasive resin infiltration technique (Icon) in the ability to improve caries lesion state (LF scores) and making the WSLs	Combination product: surface pre-reacted glass filler coating material; the ability to improve the aesthetic appearance (masking) and caries lesion state of the WSLs
Experimental: Permaseal resin; Permaseal composite resin sealant as micro-invasive resin infiltration technique in the ability to improve caries lesion state (LF scores) and making the WSLs	Combination product: surface pre-reacted glass filler coating material; the ability to improve the aesthetic appearance (masking) and caries lesion state of the WSLs
Experimental: Optiguard resin; Optiguardcomposite resin sealant as micro-invasive resin infiltration technique in the ability to improve caries lesion state (LF scores) and making the WSLs	Combination product: surface pre-reacted glass filler coating material; the ability to improve the aesthetic appearance (masking) and caries lesion state of the WSLs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessments of caries lesion state of WSLs:	Assessing of carious lesions state of WSLs, was performed by using Diagnodent pen to record the progression or regression of caries by time. The assessment of the WSLs demineralization condition took place before intervention (baseline) [T0], immediately after intervention [T1], 3 months later [T2] ,6 months later [T3] and 1 year later [T4].	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of color change of WSLs:	The difference in color of the WSLs were performed by Vita Easyshade V at the five distinct times: before intervention (baseline) [T0], immediately after intervention [T1], 3 months later [T2] ,6 months later [T3] and 1 year later [T4].	1 year

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Director: Khalid Noman, PROF, Alazhar Univerisity

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Actual): December 2, 2021
• Study Completion (Actual): December 3, 2021

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 350/466/08/10/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No