Evaluation of State and Shade of White Spot Lesions After... | NCT04671134

Studies
Evaluation of State and Shade of White Spot Lesions After Using Different Remineralizing Agents (An in Vivo Study)

NCT04671134

Sponsor

Al-Azhar University

Status

Completed

Last Update Posted

Dec 17, 2020Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

White Spot Lesion

Interventions

Biomimetic remineralizing agent
Resin Modified Glass Ionomer Varnish

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Dec 1, 2018Actual

Completion Date

Jun 1, 2019Actual

First Submitted Date

Dec 8, 2020

First Submission Date that Met QC Criteria

Dec 11, 2020

First Posted Date

Dec 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2020

Last Update Posted Date

Dec 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to evaluate the effect of Biomimetic remineralizing agent and resin modified glass ionomer varnish on color shade and state of white spot lesions immediately, after 3 months, and after 6 months. (An in vivo study).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biomimetic remineralizing agent	Experimental		Other: Biomimetic remineralizing agent Other: Resin Modified Glass Ionomer Varnish
Resin modified glass ionomer varnish	Active Comparator		Other: Biomimetic remineralizing agent Other: Resin Modified Glass Ionomer Varnish

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biomimetic remineralizing agent	Other	Self-assempling peptide	Biomimetic remineralizing agent Resin modified glass ionomer varnish

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
state of lesions	Digital scores	6 months.

Secondary Outcomes

Measure	Description	Time Frame
shade of lesions	Digital scores	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients included in this clinical trial were less than 30 years old.
Patients with good general health.
Patients who will agree to the consent and will commit to follow-up period.
Fully erupted anterior teeth with no cavitated lesions.

Exclusion Criteria:

Patients with any systemic disease that may affect normal healing.
Patient with bad oral hygiene.
Tetracycline or florosis staining.
Patients who could/would not participate in all times of follow-up.
Untreated periodontal disease was not allowed.
Active caries or defective Restorations in 6 anterior teeth.
Bleaching history
Patients participating in more than 1 dental study.
Patient received fluoride varnish before.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al-Azhar University		Cairo		11751	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided