Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05040945
Other study ID # UDDS-Ortho-08-2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2018
Est. completion date May 15, 2019

Study information

Verified date September 2021
Source Damascus University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date May 15, 2019
Est. primary completion date July 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 30 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Traditional corticotomy
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.
Flapless corticotomy
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.

Locations

Country Name City State
Syrian Arab Republic Department of Orthodontics, University of Damascus Dental School Damascus

Sponsors (1)

Lead Sponsor Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 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
Primary 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) 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 Change in the levels of swelling perception Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question 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
Secondary Change in the levels of mastication difficulty perception Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question 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
Secondary Change in the levels of swallowing difficulty perception Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question 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
Secondary Change in the levels of Jaw movement restriction perception Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question 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
Secondary The levels of satisfaction Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question This outcome will be assessed after four weeks following the surgical intervention
Secondary Which surgical intervention is more troublesome Assessment will be performed using a three-point scale:
premolar extraction.
Corticotomy procedure.
Both of them are similar.
This outcome will be assessed after four weeks following the surgical intervention
Secondary Recommendation of the procedure to a friend Assessment will be performed using a two-point scale to answer yes or no This outcome will be assessed after four weeks following the surgical intervention
See also
  Status Clinical Trial Phase
Completed NCT04619446 - Dentoskeletal Changes Produced by Growth Modification Appliances in Treatment of Skeletal Class II Malocclusion
Active, not recruiting NCT05171738 - Distalization Via Skeletally-anchored Distaljet Appliance With Two Approaches of Micro-osteoperforations N/A
Completed NCT00248014 - Response of Individuals With Class II Malocclusion Phase 2
Completed NCT01853995 - Mechanism of Class II Correction With Fixed Lingual Mandibular Growth Modificator (FLMGM) Phase 2
Completed NCT01853137 - Fixed Lingual Mandibular Growth Modificator N/A
Completed NCT04814173 - The Efficacy of Tow Mechanics for Total-maxillary-arch-distalization N/A
Recruiting NCT03839303 - Comparison Between Mini Implant Supported Appliance and Headgear in Treatment of Maxillary Excess in Growing Patients N/A
Completed NCT04847492 - Evaluation of Upper Anterior Teeth Retraction Rate Assisted by Two Corticotomy Techniques N/A
Recruiting NCT04810286 - Prefabricated Versus 3D-Printing Myofunctional Appliances N/A
Not yet recruiting NCT03764189 - Evaluation of Micro-osteoperforation on Rate of Maxillary En-masse Retraction N/A
Terminated NCT00957489 - A Prospective Randomized Controlled Trial to Evaluate the Effectiveness of the Two Different Appliances in the Treatment of Class II Division 1 Malocclusion N/A
Recruiting NCT04743258 - Bilateral Premolar Extraction vs Distalization: A Randomised Clinical Trial N/A
Active, not recruiting NCT04191070 - Distalization Using Infrazygomatic Crest Miniscrews and Zygomatic Miniplates: A Randomized Clinical Trial N/A
Completed NCT05335824 - The Effect of Autologous Platelet Concentrations on Orthodontic Treatment Time N/A
Completed NCT06133361 - The Effect of Platelet-rich Plasma on the Rate and Type of Orthodontic Tooth Movement N/A
Completed NCT05542745 - Measuring Rate of Anteriors Retraction With Two Different Techniques N/A
Completed NCT05928143 - Patient Outcomes Associated With Two Accelerated Method of Retraction of Upper Front Teeth N/A
Completed NCT04316403 - Laser-assisted Flapless Corticotomy in Accelerating Canine Retraction N/A
Not yet recruiting NCT03635463 - Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency N/A
Completed NCT03467555 - Evaluation of Distal Movement of Maxillary Dentition With Zygomatic Miniplates Using Cone Beam Computed Tomography N/A