Clinical trial NCT04601662: Evaluation of the Root Resorption and Dehiscence Formation Between Two Methods of Leveling and Alignment of Lower Teeth
Official title: Evaluation of Corticision-Based Acceleration of Lower Anterior Teeth Alignment on Root Resorption and Dehiscence Formation Using CBCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crowding of Anterior Mandibular Teeth
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The duration of orthodontic treatment is one of the exacerbation causes of orthodontic pain. Several methods have been suggested to reduce the duration of orthodontic treatment classified to surgical and non-surgical methods.

Researchers used minimally invasive surgical methods like corticision, piezocision, micro-osteoperforation, and piezopuncture indicated that most of these methods can accelerate dental movement by 20 - 40%.

The effect of corticision as a minimally invasive procedure on root resorption and dehiscence formation during orthodontic tooth movement has not been studied yet.

Applying corticision on the lower anterior teeth using a surgical blade and a hammer may accelerate tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups.

Detailed description: Orthodontically induced external root resorption accompanying orthodontic treatment is defined as a microscopic loss of root tissue as a result of the inflammatory reaction that occurs in the area of application of orthodontic force. It can be diagnosed and measured using conventional radiography or cone-beam computed tomography (CBCT).

Dehiscence is a loss of alveolar bone on the facial (rarely lingual) aspect of a tooth that leaves a characteristic v-shaped, root-exposed defect from the cementoenamel junction apically. Bone dehiscence cannot be detected through conventional radiography or clinical examination. Actually, CBCT can be considered the best accessible technique providing 3D data.

Corticision is one of the minimally invasive surgical procedures that is not associated with flap lifting. It was used to accelerate tooth movement in animals and case report studies. Its application on humans may aggravate their fear and anxiety towards the pain that may accompany this technique.

No randomized controlled trial (RCT) has compared flapless corticision in the non-extraction-based orthodontic decrowding of lower anterior teeth (LAT) with the conventional treatment in terms of external apical root resorption (EARR) and dehiscence formation (DF).

Eligibility criteria: Inclusion Criteria:

1. Age range between 18 and 24 years
2. Completion permanent dentition (except third molars)
3. Mild to moderate crowding (2-6 mm according to Little's index)
4. Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment

Exclusion Criteria:

1. Medical conditions that would affect tooth movement.
2. Cases which contraindication to oral surgery.
3. Previous orthodontic treatments.

Primary outcomes:
measure: Change in Root Length
timeFrame: T1: one day before the beginning of the orthodontic treatment, T2: exactly at 12 months following the onset of orthodontic treatment
Secondary outcomes:
measure: Change in Dehiscence Proportion
timeFrame: T1: one day before the beginning of the orthodontic treatment, T2: exactly at 12 months following the onset of orthodontic treatment
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Orthodontic Department, University of Damascus Dental School
Study officials:
affiliation: PhD student, Orthodontics Department, University of Damascus Dental School
name: Mohamad Radwan Sirri, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Orthodontics, University of Damascus, Damascus, Syria
name: Ahmad S Burhan, DDS MSc PhD
role: STUDY_DIRECTOR
affiliation: Associate Professor of Pedodontics, Syrian Private University, Damascus, Syria
name: Fehmieh R Nawaya, DDS MSc PhD
role: STUDY_DIRECTOR
References:
citation: Mandelaris GA, Neiva R, Chambrone L. Cone-Beam Computed Tomography and Interdisciplinary Dentofacial Therapy: An American Academy of Periodontology Best Evidence Review Focusing on Risk Assessment of the Dentoalveolar Bone Changes Influenced by Tooth Movement. J Periodontol. 2017 Oct;88(10):960-977. doi: 10.1902/jop.2017.160781.
citation: Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.
citation: Charavet C, Lambert F, Lecloux G, Le Gall M. [Accelerated orthodontic treatment using corticotomies: what are the minimally invasive alternatives?]. Orthod Fr. 2019 Mar;90(1):5-12. doi: 10.1051/orthodfr/2019002. Epub 2019 Apr 17. French.
citation: Makedonas D, Lund H, Hansen K. Root resorption diagnosed with cone beam computed tomography after 6 months and at the end of orthodontic treatment with fixed appliances. Angle Orthod. 2013 May;83(3):389-93. doi: 10.2319/042012-332.1. Epub 2012 Oct 23.
citation: Samandara A, Papageorgiou SN, Ioannidou-Marathiotou I, Kavvadia-Tsatala S, Papadopoulos MA. Evaluation of orthodontically induced external root resorption following orthodontic treatment using cone beam computed tomography (CBCT): a systematic review and meta-analysis. Eur J Orthod. 2019 Jan 23;41(1):67-79. doi: 10.1093/ejo/cjy027.