Evaluation of Root Resorption During the Correction of Deep Bite With the Help of Laser Irradiation

NCT05734092 | Completed DMC

• 1 other identifier: UDDS-Ortho-02-2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effectiveness of low-level laser in reducing the resorption of the roots of the upper incisors. Participants will be recruited from patients who will attend the Department of Orthodontics and Dentofacial Orthopaedics at Damascus University. The study sample will consist of 30 patients with a deep bite who will be randomly distributed equally into two groups, 15 patients in each group, average age: 22.37±3.38 years. Mini-implants will apply between the roots of the maxillary central and lateral incisor at both sides with a loading force of 40 g on each end by using a nickel-titanium spring extending from the head of the mini-implants to a wire welded to it with two hooks. A low-level laser (Ga-Al-As) will be used with 808 nm wavelength in continuous mode, 250 milli-Watt power output, 4 Joules/point energy density, 16 s per point in the experimental group. It will be applied on the day of intrusion, then on days 3,7, and 14 of the first month, and then every 15 days starting from the second month until the end of the intrusion. In addition to adjusting the force gauge every 4 weeks until the end of the intrusion stage and reaching normal coverage will be activated every 4 weeks in both groups until normal overbite was reached.

Conditions

Deep Overbite

Keywords

Low-level laser; Deep bite; Mini-implants; Root resorption

Outcome Measures

Primary Outcomes (2)

• Change in root volume

  The root volume will be measured using cone-beam computed tomography (CBCT) images. One CBCT image will be taken before starting the incisor intrusion Another image will be taken after the end of intrusion (which is expected to happen within 4 to 5 months) Each root's volume will be calculated using specific software (Mimics 21.0, Materialise NV Technologielaan, Leuven). This calculation will be performed for the upper incisors (central and lateral incisors).

  T1: One day before the beginning of the incisor intrusion procedure, T2: One day following the end of the incisor intrusion procedure which is expected to happen within 4 to five months.

• Change in root length

  The root volume will be measured using cone-beam computed tomography (CBCT) images (employing the sagittal view). One CBCT image will be taken before starting the incisor intrusion Another image will be taken after the end of intrusion (which is expected to happen within 4 to 5 months) Each root's length will be calculated using the 3D viewing software. This calculation will be performed for each tooth in the upper anterior region; i.e., upper central and lateral incisors.

  T1: One day before the beginning of the incisor intrusion procedure, T2: One day following the end of the incisor intrusion procedure which is expected to happen within 4 to five months.

Study Arms (2)

Control group

ACTIVE COMPARATOR

The strength of the nickel-titanium coil will be adjusted every 4 weeks to the required strength of 40 g on each end until reaching normal coverage

Device: Traditional orthodontic treatment

Low-Level Laser Therapy group

EXPERIMENTAL

In the experimental group (LLLT), where a (Ga-Al-As) diode laser, will be used with 808 nm wavelength in continuous mode, 250 milli-Watt power output, 4 Joules/point energy density, 16 s per point. In addition to adjusting the force gauge every 4 weeks until the end of the intrusion stage and reaching normal coverage

Device: Low-Level Laser

Interventions

Traditional orthodontic treatment DEVICE

As for patients in the control group, the strength of the nickel-titanium coil will be adjusted every 4 weeks to the required strength of 40 g on each end until reaching normal coverage.

Control group

Low-Level Laser DEVICE

The laser will be applied to the root of each of the upper incisors in 8 points (4 points from the labial and 4 points from the palatine), and the head of the device will be placed from the labial side of the root in the center of each of the apical and middle thirds and the mesial and distal of the cervical third in contact with Oral mucosa perpendicular to the root axis, with the application of the laser beam for (16) seconds at one point, and the laser will be re-applied in the same way from the palatal side of the root. So that it was the total application time is (128) seconds for one tooth. The laser will be applied on the day the upper incisor intrusion started (T1), then on days (3, 7, and 14) of the first month, and starting from the second month, the laser will be applied every (15) day, in addition to adjusting the force gauge every 4 weeks until the end of intrusion stage (T2) and reaching normal coverage.

Low-Level Laser Therapy group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• overbite \> 4 mm
• Class I or II molar and canine relationship malocclusion
• maxillary anterior crowding \< 2 mm
• maxillary incisors positioned below the functional occlusal plane
• incisor display of 2-3 mm or more at rest
• the facial growth pattern is normal or horizontal.

You may not qualify if:

• the maxillary incisors had a history of any trauma or endodontic treatment
• increased inclination of the maxillary incisors towards the labial
• the subject had any systemic disease
• the patient exhibited poor oral hygiene

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Mohammad Y. Hajeer

Damascus, Syria

Location

Related Publications (5)

• Ng D, Chan AK, Papadopoulou AK, Dalci O, Petocz P, Darendeliler MA. The effect of low-level laser therapy on orthodontically induced root resorption: a pilot double blind randomized controlled trial. Eur J Orthod. 2018 May 25;40(3):317-325. doi: 10.1093/ejo/cjx065.

  PMID: 29016741 BACKGROUND

• Jaber ST, Al-Sabbagh R, Hajeer MY. Evaluation of the efficacy of laser-assisted flapless corticotomy in accelerating canine retraction: a split-mouth randomized controlled clinical trial. Oral Maxillofac Surg. 2022 Mar;26(1):81-89. doi: 10.1007/s10006-021-00963-x. Epub 2021 Apr 20.

  PMID: 33876339 BACKGROUND

• Ang Khaw CM, Dalci O, Foley M, Petocz P, Darendeliler MA, Papadopoulou AK. Physical properties of root cementum: Part 27. Effect of low-level laser therapy on the repair of orthodontically induced inflammatory root resorption: A double-blind, split-mouth, randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2018 Sep;154(3):326-336. doi: 10.1016/j.ajodo.2018.04.022.

  PMID: 30173835 BACKGROUND

• Aras I, Tuncer AV. Comparison of anterior and posterior mini-implant-assisted maxillary incisor intrusion: Root resorption and treatment efficiency. Angle Orthod. 2016 Sep;86(5):746-52. doi: 10.2319/085015-571.1. Epub 2016 Jan 7.

  PMID: 26741306 BACKGROUND

• Altan AB, Bicakci AA, Mutaf HI, Ozkut M, Inan VS. The effects of low-level laser therapy on orthodontically induced root resorption. Lasers Med Sci. 2015 Nov;30(8):2067-76. doi: 10.1007/s10103-015-1717-6. Epub 2015 Jan 30.

  PMID: 25633918 BACKGROUND

MeSH Terms

Conditions

Overbite; Root Resorption

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class II; Malocclusion; Tooth Diseases; Stomatognathic Diseases; Tooth Resorption

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Amer Ramez Nasser, DDS

  Department of orthodontics, Damascus University, Syria

  PRINCIPAL INVESTIGATOR

• Kinda Sultan, DDS MSc PhD

  Department of orthodontics, Damascus University, Syria

  STUDY DIRECTOR

• Mohammad Y. Hajeer, DDS MSc PhD

  Department of orthodontics, Damascus University, Syria

  STUDY DIRECTOR

• Omar Hamadah, DDS MSc PhD

  Department of oral medicine, Damascus University, Syria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 17, 2023
• Study Start: November 15, 2019
• Primary Completion: July 2, 2021
• Study Completion: July 20, 2022
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)