NCT05550116

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2022

Completed
Last Updated

September 26, 2022

Status Verified

September 1, 2022

Enrollment Period

1.1 years

First QC Date

September 19, 2022

Last Update Submit

September 22, 2022

Conditions

White Spot Lesion

Keywords

white spot lesionsICONS-PRGDIAGNOdent

Outcome Measures

Primary Outcomes (1)

  • patients tooth color change

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

    1 year

Secondary Outcomes (1)

  • patients tooth caries lesion state

    1 year

Study Arms (4)

Icon resin infiltration material

ACTIVE COMPARATOR

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

Other: GiomerOther: Two composite resin sealants

PRG Barrier Coat

EXPERIMENTAL

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

Other: Two composite resin sealants

Permaseal composite resin sealant

EXPERIMENTAL

Permaseal unfilled composite resin sealants

Other: Giomer

Optiguard

EXPERIMENTAL

Optiguard unfilled composite resin sealant

Other: Giomer

Interventions

GiomerOTHER

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

Also known as: PRG Barrier Coat
Icon resin infiltration materialOptiguardPermaseal composite resin sealant
Two composite resin sealantsOTHER

Unfilled composite resin sealants

Also known as: Permaseal and Optiguard
Icon resin infiltration materialPRG Barrier Coat

Eligibility Criteria

Age19 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Wakwak

Cairo, 11768, Egypt

Location

MeSH Terms

Interventions

PRG Barrier CoatPermaSeal

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 19, 2022

First Posted

September 22, 2022

Study Start

August 11, 2021

Primary Completion

August 30, 2022

Study Completion

October 11, 2022

Last Updated

September 26, 2022

Record last verified: 2022-09

Locations

EG(1)