Stage IV PeriodontitisMOPorthoperiNCT06068270
Effect of MOPs During Orthodontic Movement in Periodontitis Patients
A study testing Micro-ostoperforations (MOPs) in people with Stage IV Periodontitis and Orthodontic Tooth Movement, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stage IV Periodontitis, Orthodontic Tooth Movement
- What is being tested?
- Micro-ostoperforations (MOPs)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 15 Dec 2023to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Faculty of Odontology, University Complutense Madrid
Madrid, Madrid, 28040
Conchita Martin, Prof, +34 91 3941901, mariacom@ucm.es
Elena Figuero, Prof, +34 91 3941901, efigueruiz@odon.ucm.es
About this study
Official title: Randomized Clinical Trial on the Effect of Micro-osteoperforations (MOPs) During Intrusion of Flared Upper Anterior Teeth in Stage IV 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)
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).
- Conditions
- Stage IV Periodontitis, Orthodontic Tooth Movement
- Being tested
- Micro-ostoperforations (MOPs)
- Keywords
- Stage IV periodontitis, Orthodontic tooth movement, Micro-osteoperforations
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-ostoperforations (MOPs)Procedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | According to randomization, test group patients will receive MOPs at the beginning of the orthodontic therapy and at every other orthodontic recall appointment. Receives: Procedure: Micro-ostoperforations (MOPs) |
| Control group | No intervention | No MOPs performed at any stage of the orthodontic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAL
clinical attachment level (CAL) in mm
Measured: 12 months
Secondary outcomes (14)
Type of movement
Description of the type of movement (categorical outcome)
Measured: 12 months
Duration of orthodontic treatment
Total duration in months
Measured: >12 months
External apical root resorption (EARR)
Presence of EARR (in mm3)
Measured: 12 months
Probing pocket depth (PPD)
PPD in mm
Measured: 12 months
Gingival margin level (GM)
GM in mm
Measured: 12 months
Gingival recessions
Recessions in mm
Measured: 12 months
Bleeding on probing (BOP)
BOP (presence or absence)
Measured: 12 months
Suppuration on probing (SOP)
SOP (presence or absence)
Measured: 12 months
Plaque index (PI)
PI (categorical outcome)
Measured: 12 months
Radiographic periodontal outcomes
Radiographic bone level (RBL), radiographic defect angle
Measured: 12 months
Inflammatory biomarkers in gingival crevicular fluid (GCF)
Inflammatory biomarkers RANKL and OPG, in picograms.
Measured: 12 months
Oral health related quality of life questionnaire (OHRQoL)
Oral health related quality of life questionnaire (OHRQoL)
Measured: 12 months
Pain questionnaire
Pain questionnaire (VAS scale 0-100)
Measured: 12 months
Aesthetic component of the Index of Orthodontic Treatment Need (IOTN)
IOTN after orthodontic therapy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start15 Dec 2023
- Primary completionOct 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV PeriodontitisStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative 2-arm parallel single-blinded randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Concepción Martín Alvaro, Universidad Complutense de Madrid
- Investigators
- Conchita Martin, Prof, Principal investigator, Universidad Complutense de MadridElena Figuero, Prof, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068270
- Sponsor's protocol ID
- URI_113-210923
- Acronym
- MOPorthoperi
- Status last verified
- Mar 2025
- First submitted
- 21 Sep 2023
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial on the Effect of Micro-osteoperforations (MOPs) During Intrusion of Flared Upper Anterior Teeth in Stage IV Periodontitis Patients
- ClinicalTrials.gov ID
- NCT06068270
- Acronym / sponsor ID
- MOPorthoperi / URI_113-210923
- Conditions
- Stage IV Periodontitis, Orthodontic Tooth Movement
- Keywords
- Stage IV periodontitis, Orthodontic tooth movement, Micro-osteoperforations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Comparative 2-arm parallel single-blinded randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: Micro-ostoperforations (MOPs)According to randomization, test group patients will receive MOPs at the beginning of the orthodontic therapy and at every other orthodontic recall appointment. |
| Control group | No intervention | –No MOPs performed at any stage of the orthodontic therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micro-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) | Procedure or surgery | Test group |
Primary outcome
CAL
Time frame: 12 months
clinical attachment level (CAL) in mm
14 secondary outcomes
Type of movement
Time frame: 12 months
Duration of orthodontic treatment
Time frame: >12 months
External apical root resorption (EARR)
Time frame: 12 months
Probing pocket depth (PPD)
Time frame: 12 months
Gingival margin level (GM)
Time frame: 12 months
Gingival recessions
Time frame: 12 months
Bleeding on probing (BOP)
Time frame: 12 months
Suppuration on probing (SOP)
Time frame: 12 months
Plaque index (PI)
Time frame: 12 months
Radiographic periodontal outcomes
Time frame: 12 months
Inflammatory biomarkers in gingival crevicular fluid (GCF)
Time frame: 12 months
Oral health related quality of life questionnaire (OHRQoL)
Time frame: 12 months
Pain questionnaire
Time frame: 12 months
Aesthetic component of the Index of Orthodontic Treatment Need (IOTN)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available
Related trials for Stage IV Periodontitis
RecruitingObservational study
Characterization of Small Intestinal Bacterial Overgrowth and Intestinal Barrier-Related Biomarkers in Patients With Severe Periodontitis
Periodontitis (Stage 3), Periodontitis Stage IV
Not yet recruiting
Minimally Invasive Non-Surgical Therapy Versus Single Flap Approach in Management of Periodontal Intrabony Defects
Intrabony Periodontal Defects
Not yet recruiting
Occlusal Force and Chewing After Periodontal Therapy
Periodontitis
Not yet recruiting
Minimally Invasive Non-Surgical Periodontal Treatment
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Active, not recruiting
Evaluation of Hyaluronic Acid and Chlorhexidine Gel as an Adjunct to Minimally Invasive Non-surgical Therapy in the Treatment of Stage III and IV Periodontitis
Periodontology, Periodontal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Conchita Martin, Prof principal investigator
Universidad Complutense de Madrid
Elena Figuero, Prof principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro-ostoperforations (MOPs) in people with Stage IV Periodontitis and Orthodontic Tooth Movement, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Conchita Martin, Prof (+343941901, mariacom@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAL (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.