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

Primary Purpose

Deep Overbite

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Traditional orthodontic treatment
Low-Level Laser
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Overbite focused on measuring Low-level laser, Deep bite, Mini-implants, Root resorption

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Mohammad Y. Hajeer

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Low-Level Laser Therapy group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Full Information

First Posted
February 8, 2023
Last Updated
February 8, 2023
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT05734092
Brief Title
Evaluation of Root Resorption During the Correction of Deep Bite With the Help of Laser Irradiation
Official Title
Investigating the Effectiveness of Low-Level Laser in Reducing Root Resorption of the Upper Incisors During Intrusion Movement Using Mini-Implants in Adult Patients With Deep Overbite: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
July 2, 2021 (Actual)
Study Completion Date
July 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Several studies have indicated the effectiveness of the LLLT in accelerating orthodontic movement, but studies that have evaluated the role of this laser in reducing the risk of OIIRR have been limited. Moreover, the effects of laser in reducing root resorption have been studied with different types of orthodontic movements such as en masse anterior retraction, canine retraction, and tilting of the premolars before extraction, but they have not been studied with the intrusion movement

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Overbite
Keywords
Low-level laser, Deep bite, Mini-implants, Root resorption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Low-Level Laser Therapy group
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Traditional orthodontic treatment
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Low-Level Laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in root volume
Description
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).
Time Frame
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.
Title
Change in root length
Description
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.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amer Ramez Nasser, DDS
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kinda Sultan, DDS MSc PhD
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohammad Y. Hajeer, DDS MSc PhD
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Omar Hamadah, DDS MSc PhD
Organizational Affiliation
Department of oral medicine, Damascus University, Syria
Official's Role
Study Director
Facility Information:
Facility Name
Mohammad Y. Hajeer
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29016741
Citation
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.
Results Reference
background
PubMed Identifier
33876339
Citation
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.
Results Reference
background
PubMed Identifier
30173835
Citation
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.
Results Reference
background
PubMed Identifier
26741306
Citation
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.
Results Reference
background
PubMed Identifier
25633918
Citation
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.
Results Reference
background

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

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