Faculty of Odontology, University Complutense Madrid
Madrid, 28040, Spain
Location status: Recruiting
Location contact
Conchita Martin, Prof
CONTACT
Elena Figuero, Prof
CONTACT
NCT Number: NCT06068270
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)
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Madrid, 28040, Spain
Location status: Recruiting
Conchita Martin, Prof
CONTACT
Elena Figuero, Prof
CONTACT
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
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)
Time frame: 12 months
clinical attachment level (CAL) in mm
Time frame: 12 months
Description of the type of movement (categorical outcome)
Time frame: >12 months
Total duration in months
Time frame: 12 months
Presence of EARR (in mm3)
Time frame: 12 months
PPD in mm
Time frame: 12 months
GM in mm
Time frame: 12 months
Recessions in mm
Time frame: 12 months
BOP (presence or absence)
Time frame: 12 months
SOP (presence or absence)
Time frame: 12 months
PI (categorical outcome)
Time frame: 12 months
Radiographic bone level (RBL), radiographic defect angle
Time frame: 12 months
Inflammatory biomarkers RANKL and OPG, in picograms.
Time frame: 12 months
Oral health related quality of life questionnaire (OHRQoL)
Time frame: 12 months
Pain questionnaire (VAS scale 0-100)
Time frame: 12 months
IOTN after orthodontic therapy
Contact information is provided by the study sponsor or research team.
Conchita Martin, Prof
CONTACT
Elena Figuero, Prof
CONTACT
Universidad Complutense de Madrid
Other
Randomized Clinical Trial on the Effect of Micro-osteoperforations (MOPs) During Intrusion of Flared Upper Anterior Teeth in Stage IV Periodontitis Patients
Acronym: MOPorthoperi
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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