Orthodontic Tooth Movement, Stage IV Periodontitis
Conditions
Keywords
Stage IV periodontitis, Orthodontic tooth movement, Micro-osteoperforations
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).
Interventions
PROCEDUREMicro-ostoperforations (MOPs)
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)
Sponsors
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Comparative 2-arm parallel single-blinded randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CAL | 12 months | clinical attachment level (CAL) in mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type of movement | 12 months | Description of the type of movement (categorical outcome) |
| Duration of orthodontic treatment | >12 months | Total duration in months |
| External apical root resorption (EARR) | 12 months | Presence of EARR (in mm3) |
| Probing pocket depth (PPD) | 12 months | PPD in mm |
| Gingival margin level (GM) | 12 months | GM in mm |
| Gingival recessions | 12 months | Recessions in mm |
| Pain questionnaire | 12 months | Pain questionnaire (VAS scale 0-100) |
| Suppuration on probing (SOP) | 12 months | SOP (presence or absence) |
| Plaque index (PI) | 12 months | PI (categorical outcome) |
| Radiographic periodontal outcomes | 12 months | Radiographic bone level (RBL), radiographic defect angle |
| Inflammatory biomarkers in gingival crevicular fluid (GCF) | 12 months | Inflammatory biomarkers RANKL and OPG, in picograms. |
| Oral health related quality of life questionnaire (OHRQoL) | 12 months | Oral health related quality of life questionnaire (OHRQoL) |
| Aesthetic component of the Index of Orthodontic Treatment Need (IOTN) | 12 months | IOTN after orthodontic therapy |
| Bleeding on probing (BOP) | 12 months | BOP (presence or absence) |
Countries
Spain
Contacts
Primary ContactConchita Martin, Prof
Backup ContactElena Figuero, Prof
Outcome results
None listed