Class II Malocclusion
Conditions
Keywords
LLLT, Piezocision, Canine retraction, Acceleration
Brief summary
Sixty patients requiring extraction-based treatment of the maxillary first premolars, followed by retraction of the maxillary canines, will be randomly assigned to three groups: piezocision, low-level laser therapy, and control. In each group, canine retraction will be initiated after completion of the leveling and alignment phase, using closed nickel-titanium coil springs that apply 150 g of force per side. For anchorage, a soldered transpalatal arch will be used. Pre- and post-distalization dental casts will be assessed to evaluate the rate of canine retraction, canine rotation, and anchorage loss over the follow-up period until a Class I canine relationship is achieved. Periodontal health will be assessed before and after canine retraction by evaluating the following parameters: plaque index, gingival index, bleeding index, and probing depth.
Detailed description
Before enrollment of each subject in the study, they will undergo a comprehensive assessment to ensure their eligibility. The operator will inform them of the study's aim and request written informed consent. At the end of the leveling and alignment stage, the upper first premolars will be extracted. The rectangular stainless steel archwires (0.019 × 0.025) will be inserted, and after one month, canine retraction will be initiated. Regarding the Piezocision, after anesthesia, three vertical incisions will be made (3-mm depth and 8-10 mm length) mesial and distal to the upper canine, as well as at an equal distance from the upper canine and the 2nd premolar. The surgical procedures will be repeated after six weeks (only the mesial and distal canine incisions will be done) Regarding low-level laser therapy (LLLT), a GaAlAs diode laser (wavelength: 810 nm; exposure time: 10 seconds per point) will be applied around the upper canine at 10 sites, buccally and palatally. The central portion of the extraction site will also be irradiated at four sites (2 buccally and two palatally). LLLT will be applied 5 times during the first month of canine retraction, then every 2 weeks until a Class I canine relationship is achieved. The upper canine destalization will be done using NiTi springs. The force level will be controlled every 2 weeks. Retraction will be stopped when a class I canine relationship is present on both sides. Dental casts will be used to quantify the anteroposterior movement of the upper canines and first molars at 30-day intervals until the Class I canine relationship is achieved.
Interventions
DEVICEConventional treatment
The upper canine destalization will be done using NiTi springs. The force level will be controlled every 2 weeks. Retraction will be stopped when a class I canine relationship in both sides.
PROCEDUREPiezocision
After anesthesia, three vertical incisions will be made (3-mm depth and 8-10 mm length) mesial and distal the upper canine as well as at an equal distance from the upper canine and 2nd premolar. The surgical procedures will be repeated after six weeks (only the mesial and distal canine incisions will be done)
DEVICELow-level laser
GaALAs diode laser (wavelength: 810 nm and exposure time of 10 seconds\\point) will be applied around the upper canine in 10 sites from buccal and palatal. The middle of the extraction site will be also irradiated in 4 sites (2 buccally and 2 palatally). The LLLT will be applied 5 times in the first month of canine retraction, then every two weeks until class I canine relationship will be achieved.
Sponsors
Damascus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to 28 Years
Healthy volunteers
No
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. Patient had previous orthodontic treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of upper canine retraction | The months required to complete the retraction procedure will be recorded. Completion of this procedure is expected to occur within four months in the experimental groups and seven months in the control group | Assessment will be performed by calculating the months required to achieve complete retraction of the upper canine retraction through clinical examination. |
| Rate of retraction | Time Frame: The calculation of the rate of retraction will be done once the retraction procedures have finished. Completion of this procedure is expected to occur within 4 months in the experimental groups and 7 months in the control group. | Assessment will be performed on study models. The amount of distance being retracted in millimeters will be divided by the duration of retraction in weeks to give an estimation of the retraction rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the plaque index | T0: immediately before the commencement of the retraction phase; T1: at the end of the retraction phase, which is expected to occur within 4 months in the experimental groups and 7 months in the control group | Assessment will be performed using a gingival probe to evaluate oral hygiene status in enrolled patients. A. (0) = No plaque. B. (1) = A film of plaque stuck to the free gingival margin and adjacent area of the tooth. C. (2) = Moderate accretion of soft deposits on the tooth and gingival margin or within the gingival pocket. D. (3) = Abundance of soft material on the tooth and gingival margin and/or within the gingival pocket. |
| Change in the gingival index | T0: immediately before the commencement of the retraction phase; T1: at the end of the retraction phase, which is expected to occur within 4 months in the experimental groups and 7 months in the control group | Assessment will be achieved using a gingival probe to assess the status of the gingival tissues around the upper teeth (from the 2nd premolar to the contralateral 2nd premolar). A. (0) = Normal gingiva. B. (1) = Mild inflammation: minor color change, slight oedema. No bleeding on probing. C. (2) = Moderate inflammation: redness, oedema, glazing, and bleeding on probing. D. (3) = Severe inflammation: marked redness and oedema, ulceration, and tendency to spontaneous bleeding. |
| Change in Molars' positions | T0: 1 day before the beginning of canine retraction; T1: after 1 month of retraction; T2: after 2 months of retraction; T3: after 3 months; and T4: at the end of retraction (expected to be within 4 months to 7 months)) | The amount of distance being traveled by the first molars is going to be measured on study models taken at monthly intervals until the end of the retraction phase. |
| Change in the probing depth | T0: immediately before the commencement of the retraction phase; T1: at the end of the retraction phase, which is expected to occur within 4 months in the experimental groups and 7 months in the control group | Assessment will be achieved using a gingival probe. It will be measured clinically as the distance from the free gingival margin to the gingival sulcus around the six maxillary anterior teeth and 2nd premolars. |
| Change in the papillary bleeding index | T0: immediately before the commencement of the retraction phase; T1: at the end of the retraction phase, which is expected to occur within 4 months in the experimental groups and 7 months in the control group | Assessment will be achieved using a gingival probe to assess the status of periodontal tissues around the upper teeth (from the 2nd premolar to the contralateral 2nd premolar). A. (0) = No bleeding. B. (1) = A single, discrete bleeding point appears. C. (2) = Several isolated bleeding points or a single fine line of blood appears. D. (3) = The interdental triangle fills with blood shortly after probing. E. (4) = Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus. |
| Change in canine' rotation | T0: 1 day before the beginning of canine retraction; T1: after 1 month of retraction; T2: after 2 months of retraction; T3: after 3 months of retraction; and T4: at the end of retraction (expected to be within 4 months to 7 months) | The amount of the rotation of canine is going to be measured on study models taken at monthly intervals until the end of the retraction phase. |
Countries
Syria
Outcome results
None listed