Effect of MOPs During Orthodontic Movement in Periodontitis Patients

NCT06068270 | Recruiting

• 1 other identifier: URI_113-210923
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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)

Conditions

Stage IV Periodontitis; Orthodontic Tooth Movement

Keywords

Stage IV periodontitis; Orthodontic tooth movement; Micro-osteoperforations

Outcome Measures

Primary Outcomes (1)

• CAL

  clinical attachment level (CAL) in mm

  12 months

Secondary Outcomes (14)

• Type of movement

  12 months

• Duration of orthodontic treatment

  >12 months

• External apical root resorption (EARR)

  12 months

• Probing pocket depth (PPD)

  12 months

• Gingival margin level (GM)

  12 months

Study Arms (2)

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.

Procedure: Micro-ostoperforations (MOPs)

Control group

NO INTERVENTION

No MOPs performed at any stage of the orthodontic therapy

Interventions

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)

Test group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Faculty of Odontology, University Complutense Madrid

Madrid, Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Conchita Martin, Prof

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

• Elena Figuero, Prof

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Conchita Martin, Prof

CONTACT

+343941901; mariacom@ucm.es

Elena Figuero, Prof

CONTACT

+343941901; efigueruiz@odon.ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Orthodontics

Model Details: Comparative 2-arm parallel single-blinded randomized controlled clinical trial

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 5, 2023
• Study Start: December 15, 2023
• Primary Completion: October 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)