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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)
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | According to randomization, test group patients will receive MOPs at the beginning of the orthodontic therapy and at every other orthodontic recall appointment. |
|
| Control group | No Intervention | No MOPs performed at any stage of the orthodontic therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micro-ostoperforations (MOPs) | Procedure | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| CAL | clinical attachment level (CAL) in mm | 12 months |
| 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 |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Conchita Martin, Prof | Contact | +343941901 | mariacom@ucm.es | |
| Elena Figuero, Prof | Contact | +343941901 | efigueruiz@odon.ucm.es |
| Name | Affiliation | Role |
|---|---|---|
| Conchita Martin, Prof | Universidad Complutense de Madrid | Principal Investigator |
| Elena Figuero, Prof | Universidad Complutense de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Odontology, University Complutense Madrid | Recruiting | Madrid | Madrid | 28040 | Spain |
There is no plan to make individual participant data (IPD) available
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Comparative 2-arm parallel single-blinded randomized controlled clinical trial
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| >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 |