Treatment of the Mandibular Dental Crowding With and Without Corticotomy Surgery

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
Dental crowding in children, adolescents or adults is the most common reason to undergo orthodontic treatment. This malocclusion, characterized by the overlapping of teeth, is caused by a lack of space. In the mandibular anterior region, it is a predisposing factor for a periodontal disease. Good oral hygiene is difficult to maintain because the dental crowding promotes plaque retention in narrow interdental spaces and complicates the passage of brushes and dental floss. The standard orthodontic treatment lasts approximately 18-30 months. If the mandibular tooth space is less than 6 mm, it can be generally treated by orthodontics without therapeutic extractions. Corticotomy has been a proven surgical technique for many years. It involves vertical interdental incisions of the gingiva and the bone with a very low thickness. It is mainly used to facilitate the movements of teeth. Dental movements associated with corticotomy may be twice as fast as those achieved with standard non-surgical treatment. The study focuses on the correction of mandibular dental crowding. Its purpose is to compare the tooth movement obtained with orthodontic treatment and minimally invasive corticotomy surgery with that obtained with standard orthodontic treatment without surgery. Patients requesting an orthodontic treatment to correct a dental crowding less than 12 mm are randomized to benefit from corticotomy surgery and orthodontic treatment (test group) or from only orthodontic treatment (control group). It is planned the inclusion of 22 patients, 11 in the test group and 11 in the control group. After two visits necessary for the recruitment phase, treatment starts for the test group with the surgery and the appliance with brackets and arches, and, for the control group, with the appliance with brackets and arches. The surgery of corticotomy is performed with a personalized surgical guide just before the placement of orthodontic appliance. The initial impressions of the patient's dental arch as well as its three-dimensional radiography (CBCT) make it possible to create a perfectly adapted guide. The incisions are made with a piezoelectric device between the roots of teeth, from the mandibular second premolar to the contralateral second mandibular premolar. The study lasts 12 months after the placement of orthodontic material. During this 12 months, periodical controls (1 week, 2 weeks and 1-12 months) are carried out. After these 12 months, all patients undergo treatment with controls specific to standard orthodontic procedure.

Official Title
-----------------
Efficacy of Minimally Invasive Corticotomy Surgery in the Orthodontic Treatment of Mandibular Dental Crowding: A Randomized Prospective Study

Conditions
-----------------
Dental Research, Orthodontics, Surgery, Oral, Maxillofacial Surgery, Tooth Disorder

Intervention / Treatment
-----------------
* Procedure: Test group with corticotomy surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group with corticotomy surgery<br>Orthodontic treatment and minimally invasive corticotomy surgery with piezoelectric device and surgical guide | Procedure: Test group with corticotomy surgery<br>* The surgery of corticotomy is performed with a piezo electric device and a personalized surgical guide just before the placement of orthodontic appliance. The initial impressions of the patient's dental arch as well as its three-dimensional radiography (CBCT) are used to create a perfectly adapted guide for minimally invasive corticotomy surgery. The incisions are made between the roots of: the second premolars and first premolars, the first lower premolars and canines, the canines and lateral incisors, the lateral incisors and central incisors, and, the two lower central incisors.<br>|
| No Intervention: Control group without corticotomy surgery<br>Standard orthodontic treatment without surgery | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Accelerated orthodontics, Alveolar corticotomy, Piezoelectric surgery, Tooth movement, Dental crowding, Guided surgery, Minimally invasive oral surgery, Mandibular anterior alignment, Randomized prospective study