Evaluation of the Levels of Pain and Discomfort Between Two Methods of Correcting Misaligned Teeth

Evaluation of the Levels of Pain and Discomfort Between Piezosurgery-assisted Corticotomy Versus Traditional Method of Aligning Crowded Lower Anterior Teeth: a Randomized Controlled Trial

Applying flapless piezocision corticotomies on the alveolar bone and separating anterior mandibular teeth using a piezosurgery device (i.e. ultrasonic waves that perform very accurate incisions without any sutures following this procedure) may improve the speed of tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups. The levels of pain and discomfort of this procedure on 18 patients (experimental group) will be evaluated,whereas the second group (control group) will receive a traditional orthodontic therapy.

Study Overview

• Status: Completed
• Conditions: Malocclusion; Surgical Incision; Crowded Teeth
• Intervention / Treatment: Procedure: Piezosurgery

Detailed Description

According to the American Association of Orthodontists (AAO), the length of comprehensive orthodontic treatment ranges between 18-30 months, depending on treatment options and individual characteristics. In addition, orthodontic treatment time ranges between 25-35 months for extraction therapies, respectively. Reducing orthodontic treatment time is one of the main goals for orthodontists, due to problems such as root resorption, periodontal disease and caries that are associated with prolonged treatment time.

Many techniques have been introduced to accelerate orthodontic tooth movement; surgical and non-surgical. The surgical approach is the most clinically applied and most tested with known predictions and stable results. Surgical approaches usually vary from total block osteotomies to flapless partial corticotomies .In spite of corticotomy-assisted orthodontic treatment efficiency, the invasiveness of these procedures (i.e. requiring full mucoperiosteal flaps elevation) might have limited their widespread acceptance among orthodontists and patients. Therefore, more conservative flapless corticotomy techniques have recently been proposed. These procedures can be accomplished in a reasonably short periods that might produce less pain and discomfort, so we will gain better patient acceptance. Although various techniques of flapless corticotomy have been reported to be successful in practice, scientific evidence on their acceptance and compatibility is little in the literature.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic, DM20AM18
    • Departments of Orthodontics and Oral and Maxillofcial Surgery, University of Damascus Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult healthy patients , Male and female, Age range: 16-26 years.
2. Severe crowding ≤ 7 (Little's irregularity index)
3. Permanent occlusion.
4. Exist all the Mandibular teeth (except third molars).

5. Good oral and periodontal health:

   • Probing depth<4 mm
   • No radiographic evidence of bone loss .
   • Gingival index≤ 1
   • Plaque index ≤ 1

Exclusion Criteria:

1. Medical problems that affect tooth movement (corticosteroid, NSAIDs, …)
2. Patients have anti indication for oral surgery ( medical - social - psycho)
3. Presence of primary teeth in the mandibular arch
4. Missing permanent mandibular teeth (except third molars).

5. Poor oral hygiene or Current periodontal disease:

   • Probing depth ≥ 4 mm
   • radiographic evidence of bone loss
   • Gingival index > 1
   • Plaque index > 1
6. Patient had previous orthodontic treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Piezosurgery; Piezosurgery-assisted corticotomy will be performed to enhance teeth alignment	Procedure: Piezosurgery; The surgical tip is going to be used to make small cuts into the cortex of the alveolar bone between the crowded teeth.; Other Names: Piezocision
No Intervention: Traditional method; No 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
Levels of Pain and Discomfort at one day	Pain and discomfort will be measured on visual analog scale	at 24 hours following the engagement of first initial arch wire in the brackets
Levels of Pain and Discomfort at seven days	Pain and discomfort will be measured on visual analog scale	at seven days following the onset of orthodontic treatment
Levels of Pain and Discomfort at 14 days	Pain and discomfort will be measured on visual analog scale	at 14 days following the onset of orthodontic treatment
Levels of Pain and Discomfort at 28 days	Pain and discomfort will be measured on visual analog scale	at 28 days following the onset of orthodontic treatment

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Principal Investigator: Omar Gibreal, DDS, MSc student, Oral and Maxillofacial Surgery Department, University of Damascus Dental School; Study Director: Bassel Brad, DDS MSc PhD, Associate Professor of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, Univ. of Damascus Dental School; Study Director: Mohammad Y Hajeer, DDS MSc PhD, Associate Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School

Publications and helpful links

General Publications

• Sebaoun JD, Surmenian J, Dibart S. [Accelerated orthodontic treatment with piezocision: a mini-invasive alternative to conventional corticotomies]. Orthod Fr. 2011 Dec;82(4):311-9. doi: 10.1051/orthodfr/2011142. Epub 2011 Nov 23. French.
• Vercellotti T, Podesta A. Orthodontic microsurgery: a new surgically guided technique for dental movement. Int J Periodontics Restorative Dent. 2007 Aug;27(4):325-31.
• Keser EI, Dibart S. Sequential piezocision: a novel approach to accelerated orthodontic treatment. Am J Orthod Dentofacial Orthop. 2013 Dec;144(6):879-89. doi: 10.1016/j.ajodo.2012.12.014.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): December 12, 2016
• Study Completion (Actual): April 23, 2017

Study Registration Dates

• First Submitted: November 24, 2016
• First Submitted That Met QC Criteria: November 24, 2016
• First Posted (Estimate): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 26, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: pain; discomfort; minimally invasive; corticotomy; piezosurgery; piezocision
• Additional Relevant MeSH Terms: Wounds and Injuries; Stomatognathic Diseases; Tooth Diseases; Malocclusion; Surgical Wound
• Other Study ID Numbers: UDDS-OMFS-02-2016

Plan for Individual participant data (IPD)

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