Evaluation of the Patient Experience With a Surgically-assisted Acceleration Method of Orthodontic Treatment

The Effect of Corticision on Perceived Pain and Discomfort for Patients With Crowded Lower Anterior Teeth in Young Adult Patients: Randomized Clinical Trial

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.

Researches used minimally invasive surgical methods like corticision, piezocesion, disicion, micro-osteoperforation, and piezopuncture indicated that most of these methods can accelerate dental movement by 20 - 40% without causing additional pain as a result of using those methods.

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.

Study Overview

• Status: Completed
• Conditions: Crowding, Tooth
• Intervention / Treatment: Procedure: Corticision; Device: Conventional fixed appliance

Detailed Description

Pain is defined as an unpleasant emotional sensory experience associated with actual or potential harm. It was mentioned as one of the most common complaints related to orthodontic treatment, and around 65-95% of patients undergoing orthodontic treatment suffer from various degrees of pain.

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 study in the literature has been searched in patient perception of pain, discomfort, levels of acceptance and satisfaction accompanied corticision application application, but in this study, these previous variables accompanied corticision technique have been studied on crowded lower anterior teeth cases which are one of the most common types of malocclusions.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic
    • University of Damascus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age range between 18 and 24 years
2. Completion of 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. Systematic diseases that could affect bone and tooth movement and no contraindication avoid oral surgery
2. Medical conditions that affect tooth movement (Corticosteroid, NSAIDs)
3. Patients had previous orthodontic treatments
4. Poor oral hygiene or concurrent periodontal disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Corticision; Corticision will be performed on the lower anterior teeth using a surgical blade and a hammer.	Procedure: Corticision; Corticision will be performed to enhance teeth alignment.
ACTIVE_COMPARATOR: Conventional method; A fixed appliance will be applied using conventional braces without any surgical procedure.	Device: Conventional fixed appliance; No surgical intervention is going to be applied to the patients in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the levels of pain	Pain is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of pain being experienced. The left end of the line refers to no pain (VAS=0) where the right end refers to maximum (unimaginable) pain (VAS=100). The level of pain is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the pain.	at 1, 7, 14 days following the onset of orthodontic treatment
Change in the levels of discomfort:	discomfort is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of discomfort being experienced. The left end of the line refers to no discomfort (VAS=0) where the right end refers to maximum discomfort (VAS=100). The level of discomfort is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the discomfort.	at 1, 7, 14 days following the onset of orthodontic treatment
Change in the levels of swelling	swelling is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of swelling being experienced. The left end of the line refers to no swelling (VAS=0) where the right end refers to maximum swelling (VAS=100). The level of swelling is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the swelling.	at 1, 7, 14 days following the onset of orthodontic treatment
Change in the perception of mastication problems:	difficulties of mastication are assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of difficulties in mastication being experienced. The left end of the line refers to no difficulties (VAS=0) where the right end refers to maximum difficulties (VAS=100). The level of difficulties in mastication are represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the difficulties of mastication.	at 1, 7, 14 days following the onset of orthodontic treatment
Number of analgesic tables taken	The number of tablets used: Patients in both groups were asked about taking analgesics and their quantity (mg) They answered about taking analgesics using a two-point scale (1. Yes or 2. No), and their quantity by mentioning how many tablets they took.	at seven days following the onset of orthodontic treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction using VAS:	Definition: satisfaction is assessed for both groups by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of satisfaction. The left end of the line refers to no satisfaction (VAS=0) where the right end refers to maximum satisfaction (VAS=100). The level of satisfaction is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the satisfaction.	At the end of leveling and alignment
Satisfaction with the ease of the procedure	is assessed for both groups by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of ease. The left end of the line refers to no ease (VAS=0) where the right end refers to maximum ease (VAS=100). The grade of ease is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the ease of the procedure.	At the end of leveling and alignment
Satisfaction through acceptability of the procedure	Patients in corticision group were asked about possibility of repeating the procedure, and they answered using a two-point scale (1. Yes or 2. No).	At the end of leveling and alignment
Satisfaction through recommending the procedure	Recommendation to a friend: Patients in corticision group were asked about making recommendation to a friend, and they answered using a two-point scale (1. Yes or 2. No).	At the end of leveling and alignment

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Principal Investigator: Mohamad Radwan Sirri, DDS MSc, Department of orthodontics, Damascus University, Syria; Study Director: Ahmad S Burhan, DDS MSc PhD, Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School; Study Director: Mohammad Y Hajeer, DDS MSc PhD, Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School; Study Director: Fehmieh R Nawaya, DDS MSc PhD, Associate Professor, Department of Pediatric Dentistry,Syrian PrivateUniversity; Study Director: Rashad MT Murad, DDS MSc PhD, Professor of Toxins and Pharmaceutics, University of Damascus, Faculty of Pharmacology

Publications and helpful links

General Publications

• Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9.
• 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.
• Alkebsi A, Al-Maaitah E, Al-Shorman H, Abu Alhaija E. Three-dimensional assessment of the effect of micro-osteoperforations on the rate of tooth movement during canine retraction in adults with Class II malocclusion: A randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2018 Jun;153(6):771-785. doi: 10.1016/j.ajodo.2017.11.026.
• Yavuz MC, Sunar O, Buyuk SK, Kantarci A. Comparison of piezocision and discision methods in orthodontic treatment. Prog Orthod. 2018 Oct 29;19(1):44. doi: 10.1186/s40510-018-0244-y.
• Uribe F, Davoody L, Mehr R, Jayaratne YSN, Almas K, Sobue T, Allareddy V, Nanda R. Efficiency of piezotome-corticision assisted orthodontics in alleviating mandibular anterior crowding-a randomized clinical trial. Eur J Orthod. 2017 Nov 30;39(6):595-600. doi: 10.1093/ejo/cjw091.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 9, 2019
• Primary Completion (ACTUAL): January 12, 2020
• Study Completion (ACTUAL): August 26, 2020

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: February 11, 2022
• First Posted (ACTUAL): February 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Discomfort; Visual analog scale; Corticision; Mild and moderate crowding; Surgical blade
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: UDDS-Ortho-03-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No