Evaluation of the Levels of Pain and Discomfort Between Two Methods of Leveling and Alignment

NCT04348526 | Completed DMC

• 1 other identifier: UDDS-Ortho-03-2020
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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, micro-osteoperforation, and piezo-puncture 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.

Conditions

Crowding

Outcome Measures

Primary Outcomes (5)

• Change in the Perception 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 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment

• Change in the Perception 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 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment

• Change in the Perception 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 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment

• Change in the Levels of Difficulties in Mastication

  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 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 difficulties of mastication.

  At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment

• Analgesic Consumption

  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.

  The 7th day following the onset of treatment (i.e. at the second visit of the patients following his orthodontic appliance bonding; one-time assessment)

Secondary Outcomes (4)

• Patients' satisfaction

  At the end of leveling and alignment which is expected to occur within 4 to 6 months

• Ease of the procedure

  At the end of leveling and alignment which is expected to occur within 4 to 6 months

• The possibility of repeating the procedure

  At the end of leveling and alignment which is expected to occur within 4 to 6 months

• Recommendation to a friend

  At the end of leveling and alignment which is expected to occur within 4 to 6 months

Study Arms (2)

Corticision

EXPERIMENTAL

Patients will undergo a corticision procedure in order to accelerate tooth movement

Procedure: Corticision

Traditional treatment

ACTIVE COMPARATOR

Patients will undergo traditional orthodontic treatment without any surgical intervention.

Procedure: Traditional orthodontic treatment

Interventions

Corticision PROCEDURE

Surgical intervention is going to be used in the interdental areas between the lower anterior teeth to accelerate tooth movement. Three incisions are going to be made

Corticision

Traditional orthodontic treatment PROCEDURE

No surgical intervention will be used, just normal orthodontic sequence of procedures.

Traditional treatment

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age range between 18 and 24 years
• Completion 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Orthodontic Department, University of Damascus Dental School

Damascus, 00963, Syria

Location

Related Publications (5)

• 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.

  PMID: 30991984 BACKGROUND

• 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.

  PMID: 29853235 BACKGROUND

• 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.

  PMID: 27129491 BACKGROUND

• 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.

  PMID: 28371882 BACKGROUND

• 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.

  PMID: 30370430 BACKGROUND

MeSH Terms

Conditions

Crowding

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior

Study Officials

• Mohamad Radwan Sirri, DDS MSc

  MSc student in Orthodontics, University of Damascus Dental School

  PRINCIPAL INVESTIGATOR

• Ahmad S Burhan, DDS MSc PhD

  Professor of Orthodontics, University of Damascus, Damascus, Syria

  STUDY CHAIR

• Mohammad Y Hajeer, DDS MSc PhD

  Professor of Orthodontics, University of Damascus Dental School, Damascus, SYRIA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 16, 2020
• Study Start: March 15, 2017
• Primary Completion: September 15, 2018
• Study Completion: February 15, 2019
• Last Updated: April 16, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)