Evaluation of Remin Pro Forte Versus Remin Pro on Treatme... | NCT04017884

Studies
Evaluation of Remin Pro Forte Versus Remin Pro on Treatment of White Spot Lesions Post Orthodontic Treatment

NCT04017884

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jan 28, 2020Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

White Spot Lesion

Interventions

Remin Pro Forte
Remin Pro

Countries

Not provided

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

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Estimated

Primary Completion Date

Oct 1, 2020Estimated

Completion Date

Nov 1, 2020Estimated

First Submitted Date

Jul 10, 2019

First Submission Date that Met QC Criteria

Jul 11, 2019

First Posted Date

Jul 12, 2019Actual

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

Jan 27, 2020

Last Update Posted Date

Jan 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

randomized clinical trial to evaluate caries regression, the change in colour and mineral content of the demineralized enamel after treatment with Remin Pro Forte paste (fluoride, hydroxyapatite, xylitol, ginger, and curcuma) and Remin pro cream which contains (fluoride, hydroxyapatite, xylitol) remineralizing agents with the null hypothesis that Remin Pro forte will have the same clinical performance as Remin Pro in remineralizing white spot lesions post-orthodontic treatment.

Detailed Description

Recently, a remineralizing water based cream containing Hydroxyapatite, Fluoride and Xylitol (Remin pro) has been introduced. It has been claimed that hydroxyapatite fills eroded enamel, fluoride seals dentinal tubules and xylitol acts as an antibacterial agents. This product has been assumed to be suitable for management of dentinal hypersensitivity, prevention of enamel demineralization and promoting remineralization of enamel subsurface lesions. There are few studies regarding the effect of calcium phosphate and hydroxyapatite-based agents on remineralization and optical appearance of White spot lesions following orthodontic therapy.

Recently a new formulation of Remin pro has been introduced called (Remin Pro Forte) with the same components of fluoride, hydroxyapatite, xylitol in addition to two natural products (Ginger, curcuma) with the rationale based behind that they have antibacterial effect against streptococcus mutans in addition to anti-cariogenic effect which is being confirmed in the scientific literature.

Follow up period is selected to be 3 months, which is enough for evaluation of the outcomes (caries regression, color change, mineral content) assessed in this study.

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Remin Pro Forte.	Experimental	intervention	Combination Product: Remin Pro
Remin pro.	Active Comparator	comparator	Combination Product: Remin Pro Forte

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Remin Pro Forte	Combination Product	a combination of chemicals with natural products cream .	Remin pro.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
caries regression	The assessment will be done by photographic image records and performing ICDAS II scoring on white spot lesions on the image records.	3 months

Secondary Outcomes

Measure	Description	Time Frame
color improvement	To assess the color improvement of white spot lesions, Digital photographs of the white spot lesions will be taken using digital camera.	3 months

Other Outcomes

Measure	Description	Time Frame
mineral content	To measure the mineral content of WSLs, the labial surfaces of the selected teeth will be assessed by VistaCam iX using a special head for taking fluorescent images according to the manufacturer's instructions.	3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

No systemic disease.
Has completed fixed orthodontic treatment, brackets debonded.
Has at least two teeth with white spot lesion.
Has received conventional periodontal therapy after orthodontic treatment.
Between the ages of 12 and 25 years of age.

Exclusion Criteria:

Presence of enamel hypoplasia or dental fluorosis.
Presence of tetracycline pigmentation.
Periodontal pocketing of 3mm or greater.
Taking antibiotics.
Presence of carious cavities.
Allergy to fluoride gel / varnish being used in study.
Subjects who had evidence of reduced salivary flow or significant tooth wear

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
mennatallah aboulnaga, MD	Contact	01016524841		mennaaboulnaga@yahoo.com

Overall Officials

Name	Affiliation	Role
mennatallah aboulnaga, MD	Cairo University	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided