Class II Malocclusion Clinical Trial
Official title:
Comparison Between the Flapless Corticotomy Enhanced by the Later Application of Low-intensity Laser Therapy on Patient-centred Outcomes and Periodontal Health in Patients Undergoing en Masse Retraction of Upper Anterior Teeth
Verified date | September 2023 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
60 patients will be treated by extraction of maxillary first premolars by applying mini-screws between the maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). They will be divided randomly into three groups in this trial. The prolonged duration of the treatment period can cause many side effects such as white spots, caries, periodontal diseases, and pain and discomfort. So many efforts have been made to reduce the treatment time. Many procedures have been introduced to accelerate orthodontic tooth movement, which can category as surgical or non-surgical. Piezocision is a minimally invasive surgical method for accelerating orthodontic tooth movement and shortening treatment time. Low-level laser therapy (LLLT) is one of the physical acceleration methods that have contributed to decreasing treatment time.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 15, 2023 |
Est. primary completion date | December 2, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 17 Years to 28 Years |
Eligibility | Inclusion Criteria: 1. Adult healthy patients, Male and female, Age range: 17-28 years. 2. Class II Division 1 malocclusion : - Mild/moderate skeletal Class II (sagittal discrepancy angle =7) - Overjet =10 - Normal or excessive facial height (Clinically and then cephalometrically assessed using these three angles: mandibular/cranial base angle, maxillary/mandibular plane angle, and facial axis angle) - Mild to moderate crowding = 4 3. Permanent occlusion. 4. Existence of all the upper 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, nonsteroidal anti-inflammatory drugs (NSAIDs), …) 2. Presence of primary teeth in the maxillary arch 3. Missing permanent maxillary teeth (except third molars). 4. Poor oral hygiene or Current periodontal disease: - Probing depth = 4 mm - radiographic evidence of bone loss - Gingival index > 1 - Plaque index > 1 5. The patient had previous orthodontic treatment |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | University of Damascus | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
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
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. — 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
Lombardo L, Ortan YO, Gorgun O, Panza C, Scuzzo G, Siciliani G. Changes in the oral environment after placement of lingual and labial orthodontic appliances. Prog Orthod. 2013 Sep 11;14:28. doi: 10.1186/2196-1042-14-28. — View Citation
Mousa MM, Hajeer MY, Burhan AS, Almahdi WH. Evaluation of patient-reported outcome measures (PROMs) during surgically-assisted acceleration of orthodontic treatment: a systematic review and meta-analysis. Eur J Orthod. 2022 Dec 1;44(6):622-635. doi: 10.1093/ejo/cjac038. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the levels of pain during the first month of treatment assessed by the VAS | Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain). | Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction. | |
Primary | Change in the levels of pain during the third month of treatment assessed by the VAS | Assessment will be performed using questionnaires via the Visual Analog Scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain). | Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction. | |
Primary | Change in the levels of discomfort during the first month of treatment assessed by the VAS | Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain). | Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction. | |
Primary | Change in the levels of discomfort during the third month of treatment assessed by the VAS | Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain). | Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction. | |
Primary | Change in the levels of swelling during the first month of treatment assessed by the VAS | Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain). | Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction. | |
Primary | Change in the levels of swelling during the third month of treatment assessed by the VAS | Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain). | Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction. | |
Primary | Change in the levels of eating difficulty during the first month of treatment assessed by the VAS | Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain). | Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction. | |
Primary | Change in the levels of eating difficulty during the third month of treatment assessed by the VAS | Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain). | Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction. | |
Primary | Change in the levels of satisfaction assessed by the VAS | Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain). | These levels will be assessed only at day 14 of month 3 following the commencement of the retraction. | |
Primary | Recommendation of the procedure to a friend | Patients are asked if they would recommend the procedure to a friend. This question is going to be answered by "Yes" or "No", i.e., dichotomous scale. | This question is going to be posed only at day 14 of month 3 following the commencement of the retraction. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05440526 -
the Mini-plate Anchored Herbst Appliance Versus the Dentally Anchored Fixed Functional Appliance
|
Phase 2/Phase 3 | |
Completed |
NCT06024382 -
The Effect of Low-level Laser Therapy on Functional Treatment of Skeletal Class II Patients
|
N/A | |
Recruiting |
NCT05684510 -
Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
|
N/A | |
Completed |
NCT05265416 -
Pain and Discomfort in Two Acceleration Methods of Canine Retraction
|
N/A | |
Completed |
NCT02000557 -
Photographic Analysis of Soft Tissue Facial Profile in Patients With Class II Malocclusion
|
N/A | |
Completed |
NCT05592977 -
Effect of Bilateral Distalization of Upper First Molars in a Group of Patients After Extraction of Maxillary Second Molars
|
N/A | |
Completed |
NCT05227859 -
Which is Better Piezosurgery or LLLT in Accelerating Orthodontic Tooth Movement
|
N/A | |
Completed |
NCT05555719 -
Dentoskeletal Effects of Two Different Fixed Functional Appliances for Correction of Class II Malocclusion: A Comparative Clinical Study
|
N/A | |
Active, not recruiting |
NCT06116500 -
Effectiveness of Modified Functional Appliance With Expander
|
N/A | |
Completed |
NCT06209086 -
Effects of Skeletal Anchored Versus Incisal Capped Twin Block Appliance in Class II Malocclusion
|
N/A | |
Completed |
NCT05466344 -
the Condylar Response of Mini-plate Anchored Rigid Fixed Functional Appliance Versus Dentally Anchored Semi-rigid One
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT05166928 -
Effect of Upper Third Molar Extraction on Distalization Carriere Motion Appliance :A Prospective Clinical Study
|
N/A | |
Completed |
NCT05652244 -
Evaluation of the Levels of Pain, Discomfort, and Functional Impairment With Two Techniques of Retraction
|
N/A | |
Active, not recruiting |
NCT06308640 -
Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography
|
N/A | |
Completed |
NCT05647720 -
Effect of Maxillary Third Molar Extraction vs. Non-extraction on Distalization of First Molars in a Group of Adolescent Patients
|
N/A | |
Not yet recruiting |
NCT03863275 -
Analysis of Muscle Activity With Myofunctional Devices, Using Surface Electromyography
|
N/A | |
Completed |
NCT06209125 -
Evaluation of Skeletal and Dental Effect of the New Hybrid Aesthetic Functional Appliance
|
N/A | |
Completed |
NCT05418413 -
The Use of an Esthetic Twin Block for Patients With Mandibular Retrusion
|
N/A | |
Recruiting |
NCT05597748 -
Modified Herbst Approach to Improve Chin Projection
|
N/A | |
Completed |
NCT05302076 -
Clinical Effects of Electrical Stimulation on Speeding up Orthodontic Tooth Movement
|
N/A |