Effect of MOPs During Orthodontic Movement in Periodontitis Patients (MOPorthoperi)

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)

Study Overview

• Status: Recruiting
• Conditions: Orthodontic Tooth Movement; Stage IV Periodontitis
• Intervention / Treatment: Procedure: Micro-ostoperforations (MOPs)

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 Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Conchita Martin, Prof; Phone Number: +343941901; Email: mariacom@ucm.es
• Study Contact Backup: Name: Elena Figuero, Prof; Phone Number: +343941901; Email: efigueruiz@odon.ucm.es

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Faculty of Odontology, University Complutense Madrid
    • Contact: Conchita Martin, Prof; Phone Number: +34 91 3941901; Email: mariacom@ucm.es
    • Contact: Elena Figuero, Prof; Phone Number: +34 91 3941901; Email: efigueruiz@odon.ucm.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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)
No Intervention: Control group; No MOPs performed at any stage of the orthodontic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAL	clinical attachment level (CAL) in mm	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of movement	Description of the type of movement (categorical outcome)	12 months
Duration of orthodontic treatment	Total duration in months	>12 months
External apical root resorption (EARR)	Presence of EARR (in mm3)	12 months
Probing pocket depth (PPD)	PPD in mm	12 months
Gingival margin level (GM)	GM in mm	12 months
Gingival recessions	Recessions in mm	12 months
Bleeding on probing (BOP)	BOP (presence or absence)	12 months
Suppuration on probing (SOP)	SOP (presence or absence)	12 months
Plaque index (PI)	PI (categorical outcome)	12 months
Radiographic periodontal outcomes	Radiographic bone level (RBL), radiographic defect angle	12 months
Inflammatory biomarkers in gingival crevicular fluid (GCF)	Inflammatory biomarkers RANKL and OPG, in picograms.	12 months
Oral health related quality of life questionnaire (OHRQoL)	Oral health related quality of life questionnaire (OHRQoL)	12 months
Pain questionnaire	Pain questionnaire (VAS scale 0-100)	12 months
Aesthetic component of the Index of Orthodontic Treatment Need (IOTN)	IOTN after orthodontic therapy	12 months

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Investigators: Principal Investigator: Conchita Martin, Prof, Universidad Complutense de Madrid; Principal Investigator: Elena Figuero, Prof, Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Orthodontic tooth movement; Micro-osteoperforations; Stage IV periodontitis
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis
• Other Study ID Numbers: URI_113-210923

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data (IPD) available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No