Using micro-osteoperforations to improve orthodontic treatment in patients with severe gum disease
Randomized Clinical Trial on the Effect of Micro-osteoperforations (MOPs) During Intrusion of Flared Upper Anterior Teeth in Stage IV Periodontitis Patients
This study is testing if a new technique called micro-osteoperforations can help people with severe gum disease move their teeth more effectively during orthodontic treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Universidad Complutense de Madrid Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT06068270 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of micro-osteoperforations (MOPs) on orthodontic tooth movement in patients suffering from stage IV periodontitis. It is a randomized controlled trial with two groups: one receiving orthodontic treatment with MOPs and the other receiving the same treatment without MOPs. The study aims to assess changes in clinical attachment level (CAL) over a 12-month period following the placement of orthodontic appliances. Participants must have specific dental conditions, including flared teeth and intrabony defects, to qualify for the trial.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with stage IV periodontitis and at least one flared tooth in the upper anterior sextant requiring orthodontic therapy.
Not a fit: Patients with systemic diseases or those on medications affecting inflammation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance orthodontic outcomes and periodontal health in patients with severe gum disease.
How similar studies have performed: While the use of MOPs in orthodontics is a relatively novel approach, preliminary studies suggest potential benefits, though comprehensive data is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madrid, Madrid
- Faculty of Odontology, University Complutense Madrid — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Conchita Martin, Prof — Universidad Complutense de Madrid
- Study coordinator: Conchita Martin, Prof
- Email: mariacom@ucm.es
- Phone: +343941901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.