Back to resultsEffect of MOPs During Orthodontic Movement in Periodontitis Patients (MOPorthoperi)
Primary Purpose
Stage IV Periodontitis, Orthodontic Tooth Movement
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Micro-ostoperforations (MOPs)
Sponsored by
About this trial
This is an interventional treatment trial for Stage IV Periodontitis focused on measuring Stage IV periodontitis, Orthodontic tooth movement, Micro-osteoperforations
Eligibility Criteria
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
Sites / Locations
- Faculty of Odontology, University Complutense MadridRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Test group
Control group
Arm Description
According to randomization, test group patients will receive MOPs at the beginning of the orthodontic therapy and at every other orthodontic recall appointment.
No MOPs performed at any stage of the orthodontic therapy
Outcomes
Primary Outcome Measures
CAL
clinical attachment level (CAL) in mm
Secondary Outcome Measures
Type of movement
Description of the type of movement (categorical outcome)
Duration of orthodontic treatment
Total duration in months
External apical root resorption (EARR)
Presence of EARR (in mm3)
Probing pocket depth (PPD)
PPD in mm
Gingival margin level (GM)
GM in mm
Gingival recessions
Recessions in mm
Bleeding on probing (BOP)
BOP (presence or absence)
Suppuration on probing (SOP)
SOP (presence or absence)
Plaque index (PI)
PI (categorical outcome)
Radiographic periodontal outcomes
Radiographic bone level (RBL), radiographic defect angle
Inflammatory biomarkers in gingival crevicular fluid (GCF)
Inflammatory biomarkers RANKL and OPG, in picograms.
Oral health related quality of life questionnaire (OHRQoL)
Oral health related quality of life questionnaire (OHRQoL)
Pain questionnaire
Pain questionnaire (VAS scale 0-100)
Aesthetic component of the Index of Orthodontic Treatment Need (IOTN)
IOTN after orthodontic therapy
Full Information
NCT ID
NCT06068270
First Posted
September 21, 2023
Last Updated
September 28, 2023
Sponsor
Universidad Complutense de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT06068270
Brief Title
Effect of MOPs During Orthodontic Movement in Periodontitis Patients
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
4. Oversight
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
Data Monitoring Committee
No
5. 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)
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Periodontitis, Orthodontic Tooth Movement
Keywords
Stage IV periodontitis, Orthodontic tooth movement, Micro-osteoperforations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparative 2-arm parallel single-blinded randomized controlled clinical trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test group
Arm Type
Experimental
Arm Description
According to randomization, test group patients will receive MOPs at the beginning of the orthodontic therapy and at every other orthodontic recall appointment.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No MOPs performed at any stage of the orthodontic therapy
Intervention Type
Procedure
Intervention Name(s)
Micro-ostoperforations (MOPs)
Intervention Description
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)
Primary Outcome Measure Information:
Title
CAL
Description
clinical attachment level (CAL) in mm
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Type of movement
Description
Description of the type of movement (categorical outcome)
Time Frame
12 months
Title
Duration of orthodontic treatment
Description
Total duration in months
Time Frame
>12 months
Title
External apical root resorption (EARR)
Description
Presence of EARR (in mm3)
Time Frame
12 months
Title
Probing pocket depth (PPD)
Description
PPD in mm
Time Frame
12 months
Title
Gingival margin level (GM)
Description
GM in mm
Time Frame
12 months
Title
Gingival recessions
Description
Recessions in mm
Time Frame
12 months
Title
Bleeding on probing (BOP)
Description
BOP (presence or absence)
Time Frame
12 months
Title
Suppuration on probing (SOP)
Description
SOP (presence or absence)
Time Frame
12 months
Title
Plaque index (PI)
Description
PI (categorical outcome)
Time Frame
12 months
Title
Radiographic periodontal outcomes
Description
Radiographic bone level (RBL), radiographic defect angle
Time Frame
12 months
Title
Inflammatory biomarkers in gingival crevicular fluid (GCF)
Description
Inflammatory biomarkers RANKL and OPG, in picograms.
Time Frame
12 months
Title
Oral health related quality of life questionnaire (OHRQoL)
Description
Oral health related quality of life questionnaire (OHRQoL)
Time Frame
12 months
Title
Pain questionnaire
Description
Pain questionnaire (VAS scale 0-100)
Time Frame
12 months
Title
Aesthetic component of the Index of Orthodontic Treatment Need (IOTN)
Description
IOTN after orthodontic therapy
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Conchita Martin, Prof
Phone
+343941901
Email
mariacom@ucm.es
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Figuero, Prof
Phone
+343941901
Email
efigueruiz@odon.ucm.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Conchita Martin, Prof
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elena Figuero, Prof
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Odontology, University Complutense Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Conchita Martin, Prof
Phone
+34 91 3941901
Email
mariacom@ucm.es
First Name & Middle Initial & Last Name & Degree
Elena Figuero, Prof
Phone
+34 91 3941901
Email
efigueruiz@odon.ucm.es
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data (IPD) available
Learn more about this trial
Effect of MOPs During Orthodontic Movement in Periodontitis Patients
We'll reach out to this number within 24 hrs