NCT07320352

Brief Summary

Assessment of Changes in Labial Bone Thickness and Root Surface After Enmasse Retraction With and Without Hard Laser Assistance:Comparative Randomized Cllinical Trial

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

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

February 28, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 23, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

1.6 years

First QC Date

November 23, 2025

Last Update Submit

December 27, 2025

Conditions

Amount of Labial Bone ThicknessAmount of Root Resorption

Outcome Measures

Primary Outcomes (2)

  • evaluation of labial bone thickness with and without hard laser.

    1year

  • evaluation of root surface changes with and without hard laser.

    1year

Study Arms (2)

Enmass retraction with hard laser therapy and effect on labial bone thickness and root resorption

EXPERIMENTAL
Procedure: Hard laser therapy biolase device

Enmass retraction without hard laser therapy and effect on labial bone thickness and root resorption

EXPERIMENTAL
Device: Enmass retraction without hard laser

Interventions

Hard laser therapy biolase devicePROCEDURE

Enmass retraction after hard laser therapy with biolase machine

Enmass retraction with hard laser therapy and effect on labial bone thickness and root resorption
Enmass retraction without hard laserDEVICE

with long hook and memory power chain

Enmass retraction without hard laser therapy and effect on labial bone thickness and root resorption

Eligibility Criteria

Age16 Years - 23 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • class 2 division1 malocclusion
  • Dentoalveolar bimaxillary protrusion
  • Extraction of maxillary 1st premolars
  • No evidence of root resorption
  • cooperative patient

You may not qualify if:

  • un cooperative patient
  • Bleeding disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

dental medicine of Al-Azhar university, girls branch.

Cairo, Egypt

Location

Related Publications (1)

  • Almagrami I, Albarakani AY, Almashraqi AA, Alhammadi MS, Al-Warafi LA, Almaqrami M, Qiao Y. Volumetric and tridimensional root resorption and alveolar bone changes in Class II malocclusion extraction protocol treated with clear aligners and fixed orthodontic appliances: A comparative study. Am J Orthod Dentofacial Orthop. 2025 May;167(5):539-549. doi: 10.1016/j.ajodo.2024.11.012. Epub 2025 Jan 9.

    PMID: 39797866RESULT

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 23, 2025

First Posted

January 6, 2026

Study Start

February 28, 2024

Primary Completion

September 20, 2025

Study Completion

October 20, 2025

Last Updated

January 6, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)