Orthodontics Clinical Trial
— CORTICOOfficial title:
Efficacy of Minimally Invasive Corticotomy Surgery in the Orthodontic Treatment of Mandibular Dental Crowding: A Randomized Prospective Study
Verified date | September 2023 |
Source | Ardentis Cliniques Dentaires |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The use of corticotomy surgery in addition to orthodontic standard treatment could accelerate the treatment. Corticotomy involves vertical interdental incisions of the gingiva and the bone with a very low thickness. Orthodontic appliances are placed immediately after the surgery. This study aims to compare the tooth movement when correcting mandibular dental crowding in two groups of patients: Test group: orthodontic treatment and minimally invasive corticotomy surgery. Control group: standard orthodontic treatment without surgery.
Status | Active, not recruiting |
Enrollment | 15 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - The patient is over 18 years old, - The dental crowding of the patient does not exceed 12 mm. The crowding, measured from the right mandibular canine to the left mandibular canine, doesn't require extraction or orthognathic surgery. - The patient has no active periodontal disease and no history of treated periodontal disease. - The patient has good dental hygiene. - The patient has no untreated decay. - The patient accepts the wear of metallic orthodontic materials. Exclusion Criteria: The patient : - is not able to understand the information given by the practitioner for legal, psychological or linguistic reasons. - will have predictable follow-up difficulties. - is pregnant. - has a high risk of endocarditis. - has severe or acquired immune deficiency. - has a malignant condition, an history of radiotherapy in the mandibular region. - has severe hematology, hemophilia, chronic renal failure, autoimmune disease, a condition requiring organ transplantation, poorly controlled diabetes, osteoporosis, rheumatoid arthritis or psychiatric illness. - is under antimitotic, immunosuppressive or high dose corticosteroid treatment. - smokes more than 10 cigarettes per day. - has a systemic disease that affects bone, such as osteoporosis, hyperparathyroidism, or vitamin D deficiency. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Ardentis Clinique Dentaire | Ecublens |
Lead Sponsor | Collaborator |
---|---|
Ardentis Cliniques Dentaires | Centre Hospitalier Universitaire Vaudois |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline tooth alignment at 12 months during the correction of the crowding in the anterior mandible. | The linear displacement (canine-to-canine) in millimeter of the anatomic contact points of each incisor from the anatomic point of the adjacent teeth is measured (method of irregularity index scoring of Little) on dental impressions with an electronic calipers.
Total alignment between 0 (total alignment) and 6 (no alignment). |
Baseline, 2 weeks, and 1, 2, 3, 4, 5, 6 and 12 months | |
Secondary | Change from baseline plaque index at 12 months. | The plaque index is scored using a periodontal probe at four sites around each tooth (mesial, distal, vestibular, palatal sides) and the average value is calculated. The range of the score is 0 to 3:
score 0: No plaque; score 1: Plaque revealed with the use of probe on the tooth surface. Thin film of plaque. score 2: Plaque observed with naked eye. Moderate accumulation of soft deposit. score 3: Abundance of soft matter. Large amount of plaque. |
Baseline, 6 and 12 months | |
Secondary | Change from baseline modified sulcus bleeding index at 12 months. | The modified sulcus bleeding index is scored using a periodontal probe at four sites around each tooth (mesial, distal, vestibular, palatal sides) and the average value is calculated. The range of the score is 0 to 3:
score 0: No bleeding when a periodontal probe is passed along the gingival margin adjacent to the tooth; score 1: Isolated bleeding; score 2: Blood forms a confluent red line on margin; score 3: Heavy or profuse bleeding. |
Baseline, 6 and 12 months | |
Secondary | Change from baseline pocket probing depth at 12 months. | The pocket probing depth measurement in millimeter is performed from the gingival margin to the epithelial attachment using a periodontal probe at four sites around each tooth (mesial, distal, vestibular, palatal sides) and the average value is calculated.
It was classified as: no/mild pocket depth =3 mm, moderate pocket depth 4-5 mm, severe pocket depth =6 mm. |
Baseline, 6 and 12 months | |
Secondary | Change from baseline bone levels to 6 months. | Measurement of height and thickness of the alveolar bone in millimeter using cone-beam computerized tomography (CBCT). | Baseline and 6 months | |
Secondary | Time-to-event of complications and adverse events | The number and nature of complications and adverse events will be recorded at each visit and compared between interventional and control groups. | Baseline, after surgery, after appliance of orthodontic material, 1 week, 2 weeks, and 1, 2, 3, 4, 5, 6 and 12 months | |
Secondary | Pain intensity measures: analog visual scale | Self reported pain intensity at each visit. It is scored 0-10 with an analog visual scale. The score is determined by measuring the distance in centimeter on the 10-cm line between the "no pain" anchor (score 0) and the patient's mark, providing a range of scores from 0-10. The maximum of pain is scored 10.
The mean of pain intensities of all patients at each control will be classified according to the following cut points: 0-0.4 cm: no pain, 0.5-4.4 cm: mild pain, 4.5-7.4 cm: moderate pain, and 7.5-10 cm: severe pain. |
Baseline, after surgery, after appliance of orthodontic material, 1 week, 2 weeks, and 1, 2, 3, 4, 5, 6 and 12 months | |
Secondary | Satisfaction measures: analog visual scale | Self reported satisfaction towards the treatment at the end of the treatment. It is scored 0-10 with an analog visual scale. The score is determined by measuring the distance in centimeter on the 10-cm line between the "no satisfaction" anchor (score 0) and the patient's mark, providing a range of scores from 0-10. The maximum of satisfaction is scored 10.
The mean of satisfaction intensities of all patients at each control will be classified according to the following cut points: 0-0.4 cm: no satisfaction, 0.5-4.4 cm: low satisfaction, 4.5-7.4 cm: moderate satisfaction, and 7.5-10 cm: high satisfaction. |
6 and 12 months |
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