Clinical trial NCT06068270: Effect of MOPs During Orthodontic Movement in Periodontitis Patients
Official title: Randomized Clinical Trial on the Effect of Micro-osteoperforations (MOPs) During Intrusion of Flared Upper Anterior Teeth in Stage IV Periodontitis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stage IV Periodontitis
Orthodontic Tooth Movement
Keywords: Stage IV periodontitis
Orthodontic tooth movement
Micro-osteoperforations
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative 2-arm parallel single-blinded randomized controlled clinical trial
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: CAL
timeFrame: 12 months
Secondary outcomes:
measure: Type of movement
timeFrame: 12 months
measure: Duration of orthodontic treatment
timeFrame: >12 months
measure: External apical root resorption (EARR)
timeFrame: 12 months
measure: Probing pocket depth (PPD)
timeFrame: 12 months
measure: Gingival margin level (GM)
timeFrame: 12 months
measure: Gingival recessions
timeFrame: 12 months
measure: Bleeding on probing (BOP)
timeFrame: 12 months
measure: Suppuration on probing (SOP)
timeFrame: 12 months
measure: Plaque index (PI)
timeFrame: 12 months
measure: Radiographic periodontal outcomes
timeFrame: 12 months
measure: Inflammatory biomarkers in gingival crevicular fluid (GCF)
timeFrame: 12 months
measure: Oral health related quality of life questionnaire (OHRQoL)
timeFrame: 12 months
measure: Pain questionnaire
timeFrame: 12 months
measure: Aesthetic component of the Index of Orthodontic Treatment Need (IOTN)
timeFrame: 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Faculty of Odontology, University Complutense Madrid
Study officials:
affiliation: Universidad Complutense de Madrid
name: Conchita Martin, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Complutense de Madrid
name: Elena Figuero, Prof
role: PRINCIPAL_INVESTIGATOR
References: