White Spot Lesions Development in Mixed Dentition Patients | NCT06798870

Studies
White Spot Lesions Development in Mixed Dentition Patients

NCT06798870

Sponsor

Mansoura University

Status

Active, not recruiting

Last Update Posted

Jan 29, 2025Actual

Enrollment

36Actual

Phase

Not Applicable

Conditions

Anterior Functional Shift

Interventions

removable appliances

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
A0207024OR	Other Identifier	A0207024OR

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2, 2024Actual

Primary Completion Date

Jan 30, 2025Estimated

Completion Date

Mar 15, 2025Estimated

First Submitted Date

Dec 30, 2024

First Submission Date that Met QC Criteria

Jan 22, 2025

First Posted Date

Jan 29, 2025Actual

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 22, 2025

Last Update Posted Date

Jan 29, 2025Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

36 patient will be divided into two equal groups. one for removable inclined plane while the other will be treated using clear aligner appliances. evaluation of the white spot lesion will be accumplished for all patients clinically before anr after completion of treatment.

Detailed Description

The sample size was calculated using G*Power (Version 3.1.9.4; Germany) and designed to have a power of 82% assuming type I statistical error of 5% and one-tailed statistical test based on Azeem and Hamid.13 The calculated sample was 15 patients in each group. The sample will be increased to include 36 patients: 18 patients per group for a 20% expected loss.

Patients with the age range of 9 to 12 years will be selected for the study. All patients and their parents will be informed of the procedures and will sign the informed consent. Patients who had periodontal diseases, bone resorption cleft lip and palate deformities, orofacial syndrome, hypoplastic enamel defects, and multiple restorations on the facial surfaces or unable to maintain good oral hygiene will be excluded from the study.

All patients will be randomly allocated into two groups according to the management protocol: inclined plane and clear aligner. The patients will be examined for any white spot lesion on the labial surface of the teeth in the upper and lower jaws clinically and using lateral and frontal intraoral photographs immediately before treatment and monthly along the treatment procedures. Each tooth will be evaluated, and the total lesions count will be recorded for each patient. All patients will be instructed to maintain good oral hygiene using fluoridated toothpaste daily.

Statistical analysis:

The incidence of the WSL in each tooth and the total lesions count will be calculated for each patient. These data will be collected and subjected to the appropriate statistical tests using the SPSS version 20.0 software for Windows (IBM, USA).

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

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Removable inclined plane group	Active Comparator	removable appliance for correcting anterior crossbite	Device: removable appliances
clear aligner	Active Comparator	clear aligner appliance for correcting anterior crossbite	Device: removable appliances

Interventions

Name	Type	Description	Arm Group Labels	Other Names
removable appliances	Device	removable appliances; clear aligner and removable inclined plane, for correcting anterior crossbite vin mixed dentition patient	Removable inclined plane group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
development of white spot lesion	examination of the teeth clinically for detecting white spot lesion	4 months

Secondary Outcomes

Measure	Description	Time Frame
the highly incidence of white spot lesion in upper and lower teeth	counting the mostly affected teeth by white spot lesion	4 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with the age range of 9 to 12 years with anterior crossbite will be selected for the study

Exclusion Criteria:

periodontal diseases, bone resorption cleft lip and palate deformities, orofacial syndrome, hypoplastic enamel defects, and multiple restorations on the facial surfaces or unable to maintain good oral hygiene

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
NEHAL F Albelasy, PhD	Egypt, Mansoura university, faculty of Dentistry, orthodontic department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry		Al Mansurah		34455	Egypt

Type	Date	Date Unknown
Release	May 26, 2025
Reset	Jun 10, 2025

Submission Tracking

Estimated Results First Submitted Date

May 26, 2025

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 26, 2025			Jun 10, 2025

Intervention Browse Module

MeSH Terms

ID	Term
D009968	Orthodontic Appliances, Removable

Ancestor Terms

ID	Term
D009967	Orthodontic Appliances
D009970	Orthodontics
D003813	Dentistry

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