NCT06380790

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

March 24, 2024

Last Update Submit

April 18, 2024

Conditions

Orthodontics

Outcome Measures

Primary Outcomes (1)

  • Rate of tooth movement

    Rate of leveling and alignment of mandibular incisors

    4 months

Secondary Outcomes (2)

  • Pain level

    1 week

  • Periodontal health

    4 months

Study Arms (2)

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

Laser-aided csfPROCEDURE

Laser-aided csf before leveling and alignment

Intervention
placebo laser-aided csfOTHER

placebo laser-aided csf before leveling and alignment

Control

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry cairo university

Cairo, Egypt

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthodontic resident

Study Record Dates

First Submitted

March 24, 2024

First Posted

April 24, 2024

Study Start

May 1, 2023

Primary Completion

May 1, 2024

Study Completion

October 1, 2024

Last Updated

April 24, 2024

Record last verified: 2024-04

Locations

EG(1)