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

NCT05562856 | Completed

• 1 other identifier: 350/466/08/10/19
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

White Spot Lesions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of color change of WSLs:

  1 year

Study Arms (4)

surface pre-reacted glass filler coating material

EXPERIMENTAL

surface pre-reacted glass filler coating material used to remineralize WSLs

Combination Product: surface pre-reacted glass filler coating material

micro-invasive resin infiltration technique (Icon)

ACTIVE COMPARATOR

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

Permaseal resin

EXPERIMENTAL

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

Optiguard resin

EXPERIMENTAL

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

Interventions

surface pre-reacted glass filler coating material COMBINATION_PRODUCT

the ability to improve the aesthetic appearance (masking) and caries lesion state of the WSLs

Optiguard resin; Permaseal resin; micro-invasive resin infiltration technique (Icon); surface pre-reacted glass filler coating material

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Mohamed Wakwak

Cairo, 11768, Egypt

Location

Study Officials

• Khalid Noman, PROF

  Alazhar Univerisity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: October 3, 2022
• Study Start: January 20, 2020
• Primary Completion: December 2, 2021
• Study Completion: December 3, 2021
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)