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NCT Number: NCT06068270

Effect of MOPs During Orthodontic Movement in Periodontitis Patients

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)

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

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:

  • 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

Treatment and study plan

Micro-ostoperforations (MOPs)

Procedure

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)

Primary outcomes

  1. CAL

    Time frame: 12 months

    clinical attachment level (CAL) in mm

Secondary outcomes

  1. Type of movement

    Time frame: 12 months

    Description of the type of movement (categorical outcome)

  2. Duration of orthodontic treatment

    Time frame: >12 months

    Total duration in months

  3. External apical root resorption (EARR)

    Time frame: 12 months

    Presence of EARR (in mm3)

  4. Probing pocket depth (PPD)

    Time frame: 12 months

    PPD in mm

  5. Gingival margin level (GM)

    Time frame: 12 months

    GM in mm

  6. Gingival recessions

    Time frame: 12 months

    Recessions in mm

  7. Bleeding on probing (BOP)

    Time frame: 12 months

    BOP (presence or absence)

  8. Suppuration on probing (SOP)

    Time frame: 12 months

    SOP (presence or absence)

  9. Plaque index (PI)

    Time frame: 12 months

    PI (categorical outcome)

  10. Radiographic periodontal outcomes

    Time frame: 12 months

    Radiographic bone level (RBL), radiographic defect angle

  11. Inflammatory biomarkers in gingival crevicular fluid (GCF)

    Time frame: 12 months

    Inflammatory biomarkers RANKL and OPG, in picograms.

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

    Time frame: 12 months

    Oral health related quality of life questionnaire (OHRQoL)

  13. Pain questionnaire

    Time frame: 12 months

    Pain questionnaire (VAS scale 0-100)

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

    Time frame: 12 months

    IOTN after orthodontic therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Conchita Martin, Prof

CONTACT

[email protected]

+343941901

Elena Figuero, Prof

CONTACT

[email protected]

+343941901

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

Randomized Clinical Trial on the Effect of Micro-osteoperforations (MOPs) During Intrusion of Flared Upper Anterior Teeth in Stage IV Periodontitis Patients

Acronym: MOPorthoperi

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 5, 2023
Registry last updated
Mar 27, 2025

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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