MOPorthoperi: Effect of MOPs During Orthodontic Movement in Periodontitis Patients

Sponsor

Universidad Complutense de Madrid (Other)

Overall Status

Recruiting

CT.gov ID

NCT06068270

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Stage IV Periodontitis Orthodontic Tooth Movement	Procedure: Micro-ostoperforations (MOPs)	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Comparative 2-arm parallel single-blinded randomized controlled clinical trialComparative 2-arm parallel single-blinded randomized controlled clinical trial

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

CAL [12 months]
clinical attachment level (CAL) in mm

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Odontology, University Complutense Madrid	Madrid		Spain	28040

Sponsors and Collaborators

Universidad Complutense de Madrid

Investigators

Principal Investigator: Conchita Martin, Prof, Universidad Complutense de Madrid
Principal Investigator: Elena Figuero, Prof, Universidad Complutense de Madrid

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Concepción Martín Alvaro, Professor in Orthodontics, Universidad Complutense de Madrid

ClinicalTrials.gov Identifier:

NCT06068270

Other Study ID Numbers:

URI_113-210923

First Posted:

Oct 5, 2023

Last Update Posted:

Oct 5, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Concepción Martín Alvaro, Professor in Orthodontics, Universidad Complutense de Madrid

Stage IV periodontitis

Orthodontic tooth movement

Micro-osteoperforations

Additional relevant MeSH terms:

Periodontitis

Study Results

No Results Posted as of Oct 5, 2023