Clinical trial NCT05734092: 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
Overall status: COMPLETED
Phase: NA
Conditions: Deep Overbite
Keywords: Low-level laser
Deep bite
Mini-implants
Root resorption
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in root volume
timeFrame: 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.
measure: Change in root length
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Mohammad Y. Hajeer
Study officials:
affiliation: Department of orthodontics, Damascus University, Syria
name: Amer Ramez Nasser, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of orthodontics, Damascus University, Syria
name: Kinda Sultan, DDS MSc PhD
role: STUDY_DIRECTOR
affiliation: Department of orthodontics, Damascus University, Syria
name: Mohammad Y. Hajeer, DDS MSc PhD
role: STUDY_DIRECTOR
affiliation: Department of oral medicine, Damascus University, Syria
name: Omar Hamadah, DDS MSc PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.