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

Not Applicable

Completed

• Conditions: Deep Overbite
• Interventions: Device: Traditional orthodontic treatment; Device: Low-Level Laser

• Registration Number: NCT05734092
• Lead Sponsor: Damascus University

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

Study Timeline

• Study Start: 2019-11-15
• Primary Completion: 2021-07-02
• Study Completion: 2022-07-20
• Status Verified: 2023-02
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-08
• Last Update Submitted: 2023-02-08
• Study First Posted: 2023-02-17
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Traditional orthodontic treatment	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
Low-Level Laser Therapy group	Low-Level Laser	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

Primary Outcome Measures

Name	Time	Method
Change in root volume	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.	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	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.	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.

Trial Locations

Locations (1)

Mohammad Y. Hajeer; 🇸🇾 Damascus, Syrian Arab Republic