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

Primary Purpose

Crowding, Tooth

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Corticision
Conventional fixed appliance
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crowding, Tooth focused on measuring Corticision, Visual analog scale, Mild and moderate crowding, Surgical blade, Pain, Discomfort

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Damascus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Corticision

Conventional method

Arm Description

Corticision will be performed on the lower anterior teeth using a surgical blade and a hammer.

A fixed appliance will be applied using conventional braces without any surgical procedure.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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).
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).

Full Information

First Posted
February 11, 2022
Last Updated
February 11, 2022
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT05250921
Brief Title
Evaluation of the Patient Experience With a Surgically-assisted Acceleration Method of Orthodontic Treatment
Official Title
The Effect of Corticision on Perceived Pain and Discomfort for Patients With Crowded Lower Anterior Teeth in Young Adult Patients: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 9, 2019 (Actual)
Primary Completion Date
January 12, 2020 (Actual)
Study Completion Date
August 26, 2020 (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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crowding, Tooth
Keywords
Corticision, Visual analog scale, Mild and moderate crowding, Surgical blade, Pain, Discomfort

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Corticision
Arm Type
Experimental
Arm Description
Corticision will be performed on the lower anterior teeth using a surgical blade and a hammer.
Arm Title
Conventional method
Arm Type
Active Comparator
Arm Description
A fixed appliance will be applied using conventional braces without any surgical procedure.
Intervention Type
Procedure
Intervention Name(s)
Corticision
Intervention Description
Corticision will be performed to enhance teeth alignment.
Intervention Type
Device
Intervention Name(s)
Conventional fixed appliance
Intervention Description
No surgical intervention is going to be applied to the patients in this group.
Primary Outcome Measure Information:
Title
Change in the levels of pain
Description
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.
Time Frame
at 1, 7, 14 days following the onset of orthodontic treatment
Title
Change in the levels of discomfort:
Description
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.
Time Frame
at 1, 7, 14 days following the onset of orthodontic treatment
Title
Change in the levels of swelling
Description
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.
Time Frame
at 1, 7, 14 days following the onset of orthodontic treatment
Title
Change in the perception of mastication problems:
Description
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.
Time Frame
at 1, 7, 14 days following the onset of orthodontic treatment
Title
Number of analgesic tables taken
Description
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.
Time Frame
at seven days following the onset of orthodontic treatment
Secondary Outcome Measure Information:
Title
Satisfaction using VAS:
Description
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.
Time Frame
At the end of leveling and alignment
Title
Satisfaction with the ease of the procedure
Description
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.
Time Frame
At the end of leveling and alignment
Title
Satisfaction through acceptability of the procedure
Description
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).
Time Frame
At the end of leveling and alignment
Title
Satisfaction through recommending the procedure
Description
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).
Time Frame
At the end of leveling and alignment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age range between 18 and 24 years Completion of permanent dentition (except third molars) Mild to moderate crowding (2-6 mm according to Little's index) Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment Exclusion Criteria: Systematic diseases that could affect bone and tooth movement and no contraindication avoid oral surgery Medical conditions that affect tooth movement (Corticosteroid, NSAIDs) Patients had previous orthodontic treatments Poor oral hygiene or concurrent periodontal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamad Radwan Sirri, DDS MSc
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmad S Burhan, DDS MSc PhD
Organizational Affiliation
Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS MSc PhD
Organizational Affiliation
Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fehmieh R Nawaya, DDS MSc PhD
Organizational Affiliation
Associate Professor, Department of Pediatric Dentistry,Syrian PrivateUniversity
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rashad MT Murad, DDS MSc PhD
Organizational Affiliation
Professor of Toxins and Pharmaceutics, University of Damascus, Faculty of Pharmacology
Official's Role
Study Director
Facility Information:
Facility Name
University of Damascus
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30991984
Citation
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.
Results Reference
background
PubMed Identifier
29853235
Citation
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.
Results Reference
background
PubMed Identifier
27129491
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.
Results Reference
background
PubMed Identifier
30370430
Citation
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.
Results Reference
background
PubMed Identifier
28371882
Citation
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.
Results Reference
background

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

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