Effect of MOPs During Orthodontic Movement in Periodontitis Patients

Orthodontic Tooth Movement Clinical Trial

— MOPorthoperi  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06068270
• Other study ID #: URI_113-210923
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: January 2026

Study information

• Verified date: December 2023
• Source: Universidad Complutense de Madrid
• Contact: Conchita Martin, Prof
• Phone: +343941901
• Email: mariacom[@]ucm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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)

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: January 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Orthodontic Tooth Movement
• Periodontitis

Intervention

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)

Locations

Country	Name	City	State
Spain	Faculty of Odontology, University Complutense Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

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