search
Back to results

Evaluation of the Levels of Pain and Discomfort Associated With Two Techniques of Corticotomy

Primary Purpose

Class II Division 1 Malocclusion

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

About this trial

This is an interventional treatment trial for Class II Division 1 Malocclusion focused on measuring Pain and discomfort, En-masse, Class II division 1, Extraction, Tooth movement acceleration, Traditional corticotomy, Fapless corticotomy, Mini-screws

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age range between 18 and 30 years.
  2. Class II division 1 malocclusion requiring extraction of upper first premolars.
  3. Mild to moderate skeletal class II malocclusion.
  4. Normal or excessive anterior facial height.
  5. No or mild crowding (tooth-size arch-length discrepancy ≤3 mm).
  6. Overjet >5 mm and <10 mm.
  7. Completion permanent dentition (regardless of third molars).
  8. No previous orthodontic treatment.
  9. No drug use or systematic disease that would affect the bone and tooth movement rate.
  10. Healthy periodontium and good oral hygiene.

Exclusion Criteria:

  1. Patients with previous orthodontic treatment.
  2. Patients with severe skeletal dysplasia in all three dimensions.
  3. Patients suffer from systemic diseases or syndromes
  4. Patients on medication for systemic disorders, pregnancy or steroid therapy.
  5. Patients showing any signs of active periodontal disease
  6. Patients with severe crowding (≥ 3.5 mm) in maxillary arch
  7. Patients with missing or extracted teeth in maxillary arch except third molar.

Sites / Locations

  • Department of Orthodontics, University of Damascus Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional corticotomy

Flapless corticotomy

Arm Description

Adult patients will be treated by en-masse retraction associated with traditional corticotomy

Adult patients will be treated by en-masse retraction associated with flapless corticotomy

Outcomes

Primary Outcome Measures

Change in the levels of pain perception
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question.The scale has a minimum scale of 0 (no pain) and a maximum scale of 100 (maximum pain).
Change in the levels of discomfort perception
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question.The scale has a minimum scale of 0 (no discomfort) and a maximum scale of 100 (maximum discomfort)

Secondary Outcome Measures

Change in the levels of swelling perception
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question
Change in the levels of mastication difficulty perception
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question
Change in the levels of swallowing difficulty perception
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question
Change in the levels of Jaw movement restriction perception
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question
The levels of satisfaction
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question
Which surgical intervention is more troublesome
Assessment will be performed using a three-point scale: premolar extraction. Corticotomy procedure. Both of them are similar.
Recommendation of the procedure to a friend
Assessment will be performed using a two-point scale to answer yes or no

Full Information

First Posted
September 2, 2021
Last Updated
September 9, 2021
Sponsor
Damascus University
search

1. Study Identification

Unique Protocol Identification Number
NCT05040945
Brief Title
Evaluation of the Levels of Pain and Discomfort Associated With Two Techniques of Corticotomy
Official Title
Evaluation of the Levels of Pain and Discomfort Associated With Traditional or Flapless Corticotomy-assisted Maxillary En-masse Retraction: a Single- Center, Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
May 15, 2019 (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
This study aims to estimate the levels of pain and discomfort associated with the en-masse retraction of the six upper anterior teeth and assisted by either conventional or flapless corticotomy. Thirty-four adult patients exhibiting class П division 1 malocclusion will be randomly allocated to either the conventional corticotomy group or the flapless corticotomy group, and they will be treated by extraction of maxillary first premolars with applying mini-screws between maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). The levels of pain and discomfort will be rated after 24 hours of corticotomy (T1), four days (T2), seven days (T3), 14 days (T4) and after 28 days of corticotomy, by asking the patients to fill in a questionnaire for assessing levels of pain and discomfort.
Detailed Description
Increasing the treatment duration is one of the most important difficulties facing the orthodontist. Several therapeutic procedures accompanying orthodontic treatment have been introduced in order to reduce the treatment duration and the most important one is the corticotomy. Although traditional corticotomy proved to be effective in accelerating different types of tooth movement, it is considered aggressive in nature. Hence, there is an interest to develop minimally invasive surgical techniques. These techniques include the flapless corticotomy using the piezosurgery device. In flapless corticotomy group, vertical soft-tissue incisions will be made on the buccal and palatal gingiva. One incision will be made between the roots of the six upper anterior teeth, and two incisions will be made between the upper canines and second premolars. The incisions will be 5 mm long and started 4 mm apical to the interdental papilla. Then a piezosurgery knife will be inserted to perform the cortical alveolar incisions with 3-mm in-depth and 8-mm in length. No suturing will be needed. In traditional corticotomy group, a full-thickness mucoperiosteal flap will be elevated, extended from the distal side of the second premolar on the right side to the same position on the left side without performing any vertical releasing incisions. The full-thickness flap will be extended 3 mm above the root apices, from the buccal and palatal sides. Then, one vertical incision between the roots of upper anterior teeth and two vertical incisions in the site of first premolar extraction will be made by the piezosurgery knife. The vertical incisions will be connected by a horizontal incision using the piezosurgery knives. The vertical incisions will be 3 mm in depth, starting 2-3 mm apical to the alveolar crest, and extending 3 mm beyond the root apices. The interrupted technique of suturing will be done using a non-absorbent 3-0 black silk. The levels of pain and discomfort will be rated after 24 hours of corticotomy (T1), four days (T2), seven days (T3), 14 days (T4) and after 28 days of corticotomy, by asking the patients to fill in a questionnaire based on the Visual Analogue Scale (VAS), and patient's responses will be obtained regarding their feelings of pain, discomfort, swelling, mastication and swallowing difficulties, jaw movement restriction, satisfaction and recommend the procedure to a friend.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Division 1 Malocclusion
Keywords
Pain and discomfort, En-masse, Class II division 1, Extraction, Tooth movement acceleration, Traditional corticotomy, Fapless corticotomy, Mini-screws

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Traditional corticotomy
Arm Type
Active Comparator
Arm Description
Adult patients will be treated by en-masse retraction associated with traditional corticotomy
Arm Title
Flapless corticotomy
Arm Type
Experimental
Arm Description
Adult patients will be treated by en-masse retraction associated with flapless corticotomy
Intervention Type
Procedure
Intervention Name(s)
Traditional corticotomy
Intervention Description
Adult patients will be treated by extraction of maxillary first premolars with applying mini-screws between maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). Then en-masse retraction associated with traditional corticotomy will be applied.
Intervention Type
Procedure
Intervention Name(s)
Flapless corticotomy
Intervention Description
Adult patients will be treated by extraction of maxillary first premolars with applying mini-screws between maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). Then en-masse retraction associated with flapless corticotomy will be applied.
Primary Outcome Measure Information:
Title
Change in the levels of pain perception
Description
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question.The scale has a minimum scale of 0 (no pain) and a maximum scale of 100 (maximum pain).
Time Frame
Levels of pain perception will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention
Title
Change in the levels of discomfort perception
Description
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question.The scale has a minimum scale of 0 (no discomfort) and a maximum scale of 100 (maximum discomfort)
Time Frame
Levels of discomfort perception will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention
Secondary Outcome Measure Information:
Title
Change in the levels of swelling perception
Description
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question
Time Frame
This outcome will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention
Title
Change in the levels of mastication difficulty perception
Description
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question
Time Frame
This outcome will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention
Title
Change in the levels of swallowing difficulty perception
Description
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question
Time Frame
This outcome will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention
Title
Change in the levels of Jaw movement restriction perception
Description
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question
Time Frame
This outcome will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention
Title
The levels of satisfaction
Description
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question
Time Frame
This outcome will be assessed after four weeks following the surgical intervention
Title
Which surgical intervention is more troublesome
Description
Assessment will be performed using a three-point scale: premolar extraction. Corticotomy procedure. Both of them are similar.
Time Frame
This outcome will be assessed after four weeks following the surgical intervention
Title
Recommendation of the procedure to a friend
Description
Assessment will be performed using a two-point scale to answer yes or no
Time Frame
This outcome will be assessed after four weeks following the surgical intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age range between 18 and 30 years. Class II division 1 malocclusion requiring extraction of upper first premolars. Mild to moderate skeletal class II malocclusion. Normal or excessive anterior facial height. No or mild crowding (tooth-size arch-length discrepancy ≤3 mm). Overjet >5 mm and <10 mm. Completion permanent dentition (regardless of third molars). No previous orthodontic treatment. No drug use or systematic disease that would affect the bone and tooth movement rate. Healthy periodontium and good oral hygiene. Exclusion Criteria: Patients with previous orthodontic treatment. Patients with severe skeletal dysplasia in all three dimensions. Patients suffer from systemic diseases or syndromes Patients on medication for systemic disorders, pregnancy or steroid therapy. Patients showing any signs of active periodontal disease Patients with severe crowding (≥ 3.5 mm) in maxillary arch Patients with missing or extracted teeth in maxillary arch except third molar.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanin Nizar Khlef, DDS,MSc
Organizational Affiliation
Specialist and Clinical Lecturer, Department of Orthodontics, University of Damascus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS,MSc,PhD
Organizational Affiliation
Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Omar Heshmeh, DDS,MSc,PhD
Organizational Affiliation
Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, Syria
Official's Role
Study Director
Facility Information:
Facility Name
Department of Orthodontics, University of Damascus Dental School
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23787192
Citation
Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20.
Results Reference
background
PubMed Identifier
31058623
Citation
Khlef HN, Hajeer MY, Ajaj MA, Heshmeh O. En-masse Retraction of Upper Anterior Teeth in Adult Patients with Maxillary or Bimaxillary Dentoalveolar Protrusion: A Systematic Review and Meta-analysis. J Contemp Dent Pract. 2019 Jan 1;20(1):113-127.
Results Reference
background
PubMed Identifier
32909702
Citation
Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B, Latifeh Y. Evaluation of patient-centered outcomes associated with the acceleration of canine retraction by using minimally invasive surgical procedures: A randomized clinical controlled trial. Dent Med Probl. 2020 Jul-Sep;57(3):285-293. doi: 10.17219/dmp/120181.
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
background
PubMed Identifier
33158633
Citation
Khlef HN, Hajeer MY, Ajaj MA, Heshmeh O, Youssef N, Mahaini L. The effectiveness of traditional corticotomy vs flapless corticotomy in miniscrew-supported en-masse retraction of maxillary anterior teeth in patients with Class II Division 1 malocclusion: A single-centered, randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2020 Dec;158(6):e111-e120. doi: 10.1016/j.ajodo.2020.08.008. Epub 2020 Nov 4.
Results Reference
background

Learn more about this trial

Evaluation of the Levels of Pain and Discomfort Associated With Two Techniques of Corticotomy

We'll reach out to this number within 24 hrs