Randomized, Blinded, Controlled Clinical Trial of Surgically Facilitated Orthodontic Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this investigation is intended to evaluate the efficacy of surgically facilitated orthodontic treatment (SFO) in terms of treatment time, incidence of root shortening, and occurrence of mucogingival side effects compared to conventional orthodontic therapy in patients undergoing orthodontic treatment to correct crowding and/or retroclination of their mandibular anterior dentition.

Detailed Description
-----------------
The null-hypothesis for this research project is that there will be no difference in the rate of orthodontic movement among patients requiring proclination or alignment of their mandibular anterior teeth with SFO (TEST group) as compared to conventional orthodontic treatment (CONTROL group). A null-hypothesis is that there will be no difference between both treatment groups in the occurrence of dental (root shortening) or periodontal (mucogingival defects, alveolar bone resorption) complications associated with orthodontic treatment.

Official Title
-----------------
Randomized, Blinded, Controlled Clinical Trial of Surgically Facilitated Orthodontic Treatment in the Mandibular Anterior Region

Conditions
-----------------
Orthodontic Malocclusion

Intervention / Treatment
-----------------
* Procedure: Surgically facilitated Orthodontic treatment
* Procedure: Conventional orthodontic treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Adults (18-65 y.o.) who seek orthodontic treatment for proclination and/or de-crowding of mandibular anterior teeth. Exclusion Criteria: Bone-related diseases Previous or current use of biphosphate therapy Previous mucogingival surgery in the area Genetic syndromes, craniofacial anomalies, or cleft lip and/or palate - History of previous orthodontic treatment less than 4 years ago Smoking >10 cigarettes/day ) Medical history that contraindicates surgical treatment, People who are not cognitively able to give consent, Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional orthodontic treatment<br>conventional orthodontic treatment in the mandibular anterior region | Procedure: Conventional orthodontic treatment<br>* Conventional orthodontic Procedure<br>|
| Experimental: Surgically facilitated Orthodontics<br>Surgically facilitated Orthodontic treatment in the mandibular anterior region | Procedure: Surgically facilitated Orthodontic treatment<br>* Surgically facilitated Orthodontic treatment in the mandibular anterior region<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of orthodontic tooth movement | Difference between the rate of orthodontic tooth movement between the two groups as measured by linear measurements on digitized study casts obtained at 4-week intervals. | 6 months(plus or minus 1 week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of mucogingival defects | Incidence of mucogingival defects as clinically measured by gingival recession (GR), clinical attachment level (CAL), probing depth (PD), width of keratinized tissue (WKT) and biotype), by a calibrated examiner | 6 months(plus or minus 2weeks) after initiation of treatment | 
| Incidence and magnitude of apical root resorption | Incidence and magnitude of apical root resorption will be estimated from pre- and post-treatment cone-beam computed tomograms (CBCTs) | 6(plus or minus 1) months following initiation of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
orthodontics, Tooth Movement, Bone Remodeling, Mandible, Osteotomy