Effect of MOPs During Orthodontic Movement in Periodontitis Patients

Study Overview
=================
Brief Summary
-----------------
Micro-osteoperforations (MOPs) cause cortical bone injuries and consequently increase the expression of inflammatory mediators, allowing for increased bone and periodontal ligament remodeling associated with orthodontic movement. It remains unclear the effect of orthodontic intrusion combined with MOPs application on teeth with reduced periodontium. The general objective will be to determine the efficacy of MOPs during orthodontic tooth movement (OTM) in terms of periodontal and orthodontic outcomes in stage IV periodontitis patients, case type 2 with pathological tooth migration (PTM), characterized the presence of at least one flared tooth of the upper-anterior sextant with an intrabony defect (intrabony component <5mm)

Detailed Description
-----------------
This is a comparative 2-arm parallel single-blinded randomized controlled clinical trial, with allocation ratio of 1:1, aimed to test an intervention (the use of MOPs) on CAL changes 12 months after placing orthodontic appliances. The control intervention will be the same treatment without the bone traumatic intervention. Sample: Patients with stage IV periodontitis case type 2 characterized with PTM characterized the presence of at least one flared tooth of the upper-anterior sextant with an intrabony defect (intrabony component <5mm) attending the Post-graduate Program of Periodontology and the Post-graduate Program of Orthodontics of the Faculty of Dentistry at the Complutense University of Madrid (UCM).

Official Title
-----------------
Randomized Clinical Trial on the Effect of Micro-osteoperforations (MOPs) During Intrusion of Flared Upper Anterior Teeth in Stage IV Periodontitis Patients

Conditions
-----------------
Stage IV Periodontitis, Orthodontic Tooth Movement

Intervention / Treatment
-----------------
* Procedure: Micro-ostoperforations (MOPs)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be included if agreeing to undertake combined periodontal and orthodontic therapy following the clinical practice guideline of stage IV periodontitis patients, and fulfilling the following criteria: adult patients older than 18-year-old; systemically healthy (see exclusion criteria); diagnosed as stage IV (Papapanou et al., 2018) case-type 2 (Herrera et al. 2022) periodontitis; the presence of at least one flared tooth of the upper-anterior sextant with an intrabony defect (intrabonny component <5mm) (experimental teeth); in need of orthodontic therapy. Exclusion Criteria: systemic diseases (diabetes mellitus, obesity, cardiovascular diseases); any medication that could affect the level of inflammation, (such as chronic antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroids, or calcium channel blockers); pregnant or lactating woman; inability to respond questions or to attend follow-up visits; extreme skeletal malocclusions requiring orthognathic surgery; patients smoking more than 10 cigarettes/day; and the presence of PD greater or equal to 5mm with BOP after step 3 of periodontal therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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
Interventional Model Description: Comparative 2-arm parallel single-blinded randomized controlled clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>According to randomization, test group patients will receive MOPs at the beginning of the orthodontic therapy and at every other orthodontic recall appointment. | Procedure: Micro-ostoperforations (MOPs)<br>* 3 MOPs will be performed in the bone next to the root of the experimental tooth. MOPs will be performed using the Excellerator® (Propel Orthodontics, Denstply, Sirona)<br>|
| No Intervention: Control group<br>No MOPs performed at any stage of the orthodontic therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAL | clinical attachment level (CAL) in mm | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of movement | Description of the type of movement (categorical outcome) | 12 months | 
| Duration of orthodontic treatment | Total duration in months | >12 months | 
| External apical root resorption (EARR) | Presence of EARR (in mm3) | 12 months | 
| Probing pocket depth (PPD) | PPD in mm | 12 months | 
| Gingival margin level (GM) | GM in mm | 12 months | 
| Gingival recessions | Recessions in mm | 12 months | 
| Bleeding on probing (BOP) | BOP (presence or absence) | 12 months | 
| Suppuration on probing (SOP) | SOP (presence or absence) | 12 months | 
| Plaque index (PI) | PI (categorical outcome) | 12 months | 
| Radiographic periodontal outcomes | Radiographic bone level (RBL), radiographic defect angle | 12 months | 
| Inflammatory biomarkers in gingival crevicular fluid (GCF) | Inflammatory biomarkers RANKL and OPG, in picograms. | 12 months | 
| Oral health related quality of life questionnaire (OHRQoL) | Oral health related quality of life questionnaire (OHRQoL) | 12 months | 
| Pain questionnaire | Pain questionnaire (VAS scale 0-100) | 12 months | 
| Aesthetic component of the Index of Orthodontic Treatment Need (IOTN) | IOTN after orthodontic therapy | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stage IV periodontitis, Orthodontic tooth movement, Micro-osteoperforations