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

Primary Purpose

Malocclusion, Crowded Teeth, Surgical Incision

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

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring corticotomy, minimally invasive, piezosurgery, piezocision, pain, discomfort

Eligibility Criteria

16 Years - 26 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Departments of Orthodontics and Oral and Maxillofcial Surgery, University of Damascus Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Piezosurgery

Traditional method

Arm Description

Piezosurgery-assisted corticotomy will be performed to enhance teeth alignment

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

Outcomes

Primary Outcome Measures

Levels of Pain and Discomfort at one day
Pain and discomfort will be measured on visual analog scale
Levels of Pain and Discomfort at seven days
Pain and discomfort will be measured on visual analog scale
Levels of Pain and Discomfort at 14 days
Pain and discomfort will be measured on visual analog scale
Levels of Pain and Discomfort at 28 days
Pain and discomfort will be measured on visual analog scale

Secondary Outcome Measures

Full Information

First Posted
November 24, 2016
Last Updated
July 26, 2017
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT02975765
Brief Title
Evaluation of the Levels of Pain and Discomfort Between Two Methods of Correcting Misaligned Teeth
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 12, 2016 (Actual)
Study Completion Date
April 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Crowded Teeth, Surgical Incision
Keywords
corticotomy, minimally invasive, piezosurgery, piezocision, pain, discomfort

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Piezosurgery
Arm Type
Experimental
Arm Description
Piezosurgery-assisted corticotomy will be performed to enhance teeth alignment
Arm Title
Traditional method
Arm Type
No Intervention
Arm Description
No intervention is going to be applied to the patients in this group.
Intervention Type
Procedure
Intervention Name(s)
Piezosurgery
Other Intervention Name(s)
Piezocision
Intervention Description
The surgical tip is going to be used to make small cuts into the cortex of the alveolar bone between the crowded teeth.
Primary Outcome Measure Information:
Title
Levels of Pain and Discomfort at one day
Description
Pain and discomfort will be measured on visual analog scale
Time Frame
at 24 hours following the engagement of first initial arch wire in the brackets
Title
Levels of Pain and Discomfort at seven days
Description
Pain and discomfort will be measured on visual analog scale
Time Frame
at seven days following the onset of orthodontic treatment
Title
Levels of Pain and Discomfort at 14 days
Description
Pain and discomfort will be measured on visual analog scale
Time Frame
at 14 days following the onset of orthodontic treatment
Title
Levels of Pain and Discomfort at 28 days
Description
Pain and discomfort will be measured on visual analog scale
Time Frame
at 28 days following the onset of orthodontic treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult healthy patients , Male and female, Age range: 16-26 years. Severe crowding ≤ 7 (Little's irregularity index) Permanent occlusion. Exist all the Mandibular teeth (except third molars). Good oral and periodontal health: Probing depth<4 mm No radiographic evidence of bone loss . Gingival index≤ 1 Plaque index ≤ 1 Exclusion Criteria: Medical problems that affect tooth movement (corticosteroid, NSAIDs, …) Patients have anti indication for oral surgery ( medical - social - psycho) Presence of primary teeth in the mandibular arch Missing permanent mandibular teeth (except third molars). Poor oral hygiene or Current periodontal disease: Probing depth ≥ 4 mm radiographic evidence of bone loss Gingival index > 1 Plaque index > 1 Patient had previous orthodontic treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Gibreal, DDS
Organizational Affiliation
MSc student, Oral and Maxillofacial Surgery Department, University of Damascus Dental School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bassel Brad, DDS MSc PhD
Organizational Affiliation
Associate Professor of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, Univ. of Damascus Dental School
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS MSc PhD
Organizational Affiliation
Associate Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School
Official's Role
Study Director
Facility Information:
Facility Name
Departments of Orthodontics and Oral and Maxillofcial Surgery, University of Damascus Dental School
City
Damascus
ZIP/Postal Code
DM20AM18
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22105680
Citation
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.
Results Reference
background
PubMed Identifier
17726988
Citation
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.
Results Reference
background
PubMed Identifier
24286911
Citation
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.
Results Reference
background
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
derived

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

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