Effect of Laser-aided Csf on the Rate of Leveling and Ali... | NCT06380790

Studies
Effect of Laser-aided Csf on the Rate of Leveling and Alignment of Mandibular Anterior Crowding

NCT06380790

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Apr 24, 2024Actual

Enrollment

26Estimated

Phase

Not Applicable

Conditions

Orthodontics

Interventions

Laser-aided csf
placebo laser-aided csf

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

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2023Actual

Primary Completion Date

May 2024Estimated

Completion Date

Oct 2024Estimated

First Submitted Date

Mar 24, 2024

First Submission Date that Met QC Criteria

Apr 18, 2024

First Posted Date

Apr 24, 2024Actual

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

Apr 18, 2024

Last Update Posted Date

Apr 24, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sarah Khaled Mohamed Hamed Abdelkader, Orthodontic resident, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

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

To test the effect of laser-aided circumferential supracrestal fiberotomy on the rate of leveling and alignment

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

26Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Other	Placebo laser-aided csf	Other: placebo laser-aided csf
Intervention	Other	Laser-aided csf before leveling and alignment	Procedure: Laser-aided csf

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser-aided csf	Procedure	Laser-aided csf before leveling and alignment	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of tooth movement	Rate of leveling and alignment of mandibular incisors	4 months

Secondary Outcomes

Measure	Description	Time Frame
Pain level	Visual Analogue Scale	1 week
Periodontal health	Gingival index	4 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients indicated for orthodontic treatment 18-25 years
full permanent dentition (not necessarily third molars)
mandibular anterior crowding
no visible anomaly of enamel
good oral hygiene

Exclusion Criteria:

patients with mandibular anterior teeth with advanced caries, prosthetic restorations or dental anomalies
patients with dentofacial deformities or medical problems
patients indicated for extractions as a part of orthodontic treatment
patients with severe mandibular gingival inflammation/periodontitis
pregnant female patients
patients with previous orthodontic treatment
patients with previous mandibular extractions except third molars
patients taking medications that could alter orthodontic treatment
patients with clefts,syndromes, systemic diseases

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 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
Faculty of dentistry cairo university	Recruiting	Cairo			Egypt