CClinicalTrials.gg
Sign In
RecruitingNCT06068270MOPorthoperiUpdated Mar 27, 2025

Effect of MOPs During Orthodontic Movement in Periodontitis Patients

An interventional study of Micro-ostoperforations (MOPs) in Stage IV Periodontitis and Orthodontic Tooth Movement, sponsored by Universidad Complutense de Madrid. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-27.

Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started Dec 2023; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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)

Read the 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).

02

Conditions studied

  • Stage IV Periodontitis
  • Orthodontic Tooth Movement

Browse trials for

Keywords

  • Stage IV periodontitis
  • Orthodontic tooth movement
  • Micro-osteoperforations
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's planned enrollment of 28 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Universidad Complutense de Madrid is the lead sponsor of 200 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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.

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    Test group

    According to randomization, test group patients will receive MOPs at the beginning of the orthodontic therapy and at every other orthodontic recall appointment.

    Procedure: Micro-ostoperforations (MOPs)

  • No intervention
    Control group

    No MOPs performed at any stage of the orthodontic therapy

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)

06

What researchers measure

Primary outcomes

  1. CAL

    clinical attachment level (CAL) in mm

    Time frame: 12 months

Secondary outcomes

  1. Type of movement

    Description of the type of movement (categorical outcome)

    Time frame: 12 months

  2. Duration of orthodontic treatment

    Total duration in months

    Time frame: >12 months

  3. External apical root resorption (EARR)

    Presence of EARR (in mm3)

    Time frame: 12 months

  4. Probing pocket depth (PPD)

    PPD in mm

    Time frame: 12 months

  5. Gingival margin level (GM)

    GM in mm

    Time frame: 12 months

  6. Gingival recessions

    Recessions in mm

    Time frame: 12 months

  7. Bleeding on probing (BOP)

    BOP (presence or absence)

    Time frame: 12 months

  8. Suppuration on probing (SOP)

    SOP (presence or absence)

    Time frame: 12 months

  9. Plaque index (PI)

    PI (categorical outcome)

    Time frame: 12 months

  10. Radiographic periodontal outcomes

    Radiographic bone level (RBL), radiographic defect angle

    Time frame: 12 months

  11. Inflammatory biomarkers in gingival crevicular fluid (GCF)

    Inflammatory biomarkers RANKL and OPG, in picograms.

    Time frame: 12 months

  12. Oral health related quality of life questionnaire (OHRQoL)

    Oral health related quality of life questionnaire (OHRQoL)

    Time frame: 12 months

  13. Pain questionnaire

    Pain questionnaire (VAS scale 0-100)

    Time frame: 12 months

  14. Aesthetic component of the Index of Orthodontic Treatment Need (IOTN)

    IOTN after orthodontic therapy

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Faculty of Odontology, University Complutense Madrid
    Madrid, 28040, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — There is no plan to make individual participant data (IPD) available

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06068270
Lead sponsor
Universidad Complutense de Madrid
Responsible party
Concepción Martín Alvaro (Professor in Orthodontics, Universidad Complutense de Madrid) — Principal investigator
First posted
Oct 5, 2023
Start date
Dec 15, 2023
Primary completion
Oct 2025 (estimated)
Completion
Jan 2026 (estimated)
Last update
Mar 27, 2025

Study contacts

Conchita Martin, Prof
Contact
mariacom@ucm.es
+343941901
Elena Figuero, Prof
Contact
efigueruiz@odon.ucm.es
+343941901
Conchita Martin, Prof
principal investigator · Universidad Complutense de Madrid
Elena Figuero, Prof
principal investigator · Universidad Complutense de Madrid

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Periodontitis→

Other studies from this sponsor

Universidad Complutense de Madrid

Start the discussion