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

NCT05250921 | Completed DMC

• 1 other identifier: UDDS-Ortho-03-2022
• Study Type: interventional
• Target: 52
• 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, 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.

Conditions

Crowding, Tooth

Keywords

Corticision; Visual analog scale; Mild and moderate crowding; Surgical blade; Pain; Discomfort

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Satisfaction using VAS:

  At the end of leveling and alignment

• Satisfaction with the ease of the procedure

  At the end of leveling and alignment

• Satisfaction through acceptability of the procedure

  At the end of leveling and alignment

• Satisfaction through recommending the procedure

  At the end of leveling and alignment

Study Arms (2)

Corticision

EXPERIMENTAL

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

Procedure: Corticision

Conventional method

ACTIVE COMPARATOR

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

Device: Conventional fixed appliance

Interventions

Corticision PROCEDURE

Corticision will be performed to enhance teeth alignment.

Corticision

Conventional fixed appliance DEVICE

No surgical intervention is going to be applied to the patients in this group.

Conventional method

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 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

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)

University of Damascus

Damascus, 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

• 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

• 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

MeSH Terms

Conditions

Malocclusion; Lymphoma, Follicular; Pain

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamad Radwan Sirri, DDS MSc

  Department of orthodontics, Damascus University, Syria

  PRINCIPAL INVESTIGATOR

• 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

  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: February 11, 2022
• First Posted: February 22, 2022
• Study Start: March 9, 2019
• Primary Completion: January 12, 2020
• Study Completion: August 26, 2020
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)