Effect of MOPs During Orthodontic Movement in Periodontitis Patients

Not Applicable

Recruiting

• Conditions: Stage IV Periodontitis; Orthodontic Tooth Movement
• Interventions: Procedure: Micro-ostoperforations (MOPs)

• Registration Number: NCT06068270
• Lead Sponsor: Universidad Complutense de Madrid

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)

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 Timeline

• Study First Submitted: 2023-09-21
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-05
• Study Start: 2023-12-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-10
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	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.

Primary Outcome Measures

Name	Time	Method
CAL	12 months	clinical attachment level (CAL) in mm

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Odontology, University Complutense Madrid; 🇪🇸 Madrid, Spain