Assessment of Changes in Labial Bone Thickness and Root Surface After Enmasse Retraction With and Without Hard Laser Assistance

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

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

Study Overview

• Status: Completed
• Conditions: Amount of Labial Bone Thickness; Amount of Root Resorption
• Intervention / Treatment: Procedure: Hard laser therapy biolase device; Device: Enmass retraction without hard laser

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • dental medicine of Al-Azhar university, girls branch.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• un cooperative patient
• Bleeding disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enmass retraction with hard laser therapy and effect on labial bone thickness and root resorption	Procedure: Hard laser therapy biolase device; Enmass retraction after hard laser therapy with biolase machine
Experimental: Enmass retraction without hard laser therapy and effect on labial bone thickness and root resorption	Device: Enmass retraction without hard laser; with long hook and memory power chain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
evaluation of labial bone thickness with and without hard laser.	1year
evaluation of root surface changes with and without hard laser.	1year

Collaborators and Investigators

• Sponsor: Faculty of Dental Medicine for Girls

Publications and helpful links

General Publications

• 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.

Helpful Links

• Volumetric and tridimensional root resorption and alveolar bone changes in Class II malocclusion extraction protocol

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2024
• Primary Completion (Actual): September 20, 2025
• Study Completion (Actual): October 20, 2025

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: December 27, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 27, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ORTHO-108-2-K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No