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

April 18, 2024 updated by: Sarah Khaled Mohamed Hamed Abdelkader, Cairo University

Effect of Laser-aided Circumferential Supracrestal Fiberotomy on the Rate of Leveling and Alignment of Mandibular Anterior Crowding: A Randomized Controlled Clinical Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of Dentistry Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Placebo laser-aided csf
Other: placebo laser-aided csf
placebo laser-aided csf before leveling and alignment
Other: Intervention
Laser-aided csf before leveling and alignment
Procedure: Laser-aided csf
Laser-aided csf before leveling and alignment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

March 24, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 8423

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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