Timing of Orthodontic Therapy and Regenerative Periodontal Surgery in Advanced Periodontitis Patients With Pathologic Tooth Migration
Primary Purpose
Periodontitis, Tooth Migration, Intrabony Periodontal Defect
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ParS+Ortho 4W
ParS+Ortho 6M
Sponsored by

About this trial
This is an interventional treatment trial for Periodontitis focused on measuring Pathological tooth migration, periodontal regenerative surgery, vertical infrabony defects, xenogeneic bone graft, orthodontic therapy
Eligibility Criteria
Inclusion Criteria:
- Advanced periodontitis
- Presence of intrabony defects at a minimum of 2 and a maximum of 7 adjacent teeth (positions 15-25 or 35-45) in either the maxilla or the mandible with PPD of ≥6 mm at a minimum on one site
- Pathologic tooth migration
- Full mouth plaque index (PI) <25% at baseline (after initial non-surgical periodontal therapy)
- Full mouth bleeding on probing (FMBP) <25% at baseline (i.e., following initial non-surgical periodontal therapy)
- Committed to the study and the required follow-up visits
Exclusion Criteria:
Any contraindications for oral surgical procedures
- Uncontrolled diabetes or other uncontrolled systemic diseases
- Disorders or treatments that compromise wound healing
- Medical conditions requiring chronic high dose steroid therapy
- Bone metabolic diseases
- Radiation or other immuno-suppressive therapy
- Infections or vascular impairment at the surgical site
- Presence of oral lesions (such as ulceration, malignancy) or mucosal diseases
- History of malignant disease in the oral cavity or previous radiotherapy to the head
- Inadequate oral hygiene or unmotivated for adequate home care
- Current smokers > 6Cig
Sites / Locations
- Poliklinik für Parodontologie, Zahnerhaltung und Präventive Zahnheilkunde
- Master de Periodoncia Universidad Complutense
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ParS+Ortho 4W
ParS+Ortho 6M
Arm Description
Orthodontic alignment starts 4 weeks post surgical
Orthodontic alignment starts 6 months post surgical
Outcomes
Primary Outcome Measures
Clinical attachment level (CAL) at test site
Clinical attachment level (CAL)measurements 12 months after surgery
Secondary Outcome Measures
Probing depth (PD) at test site
Probing depth (PD) )measurements 12 and 24 months after surgery
Mean probing depth (PD)
Mean probing depth (PD) )measurements 12 and 24 months after surgery
Bleeding on Probing (BoP) at test site
Bleeding on Probing (BoP) measurements 12 and 24 months after surgery
Mean bleeding on Probing (BoP)
Mean Bleeding on Probing (BoP) measurements 12 and 24 months after surgery
Plaque (PI) at test site
Plaque (PI) measurements 12 and 24 months after surgery
Mean Plaque (PI)
Plaque (PI) measurements 12 months after surgery
Mean clinical attachment level (CAL)
Mean clinical attachment level (CAL)12 months after surgery
PROMS
Patient reported Outcomes
Full Information
NCT ID
NCT02761668
First Posted
April 30, 2016
Last Updated
March 27, 2023
Sponsor
University of Bonn
Collaborators
Universidad Complutense de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT02761668
Brief Title
Timing of Orthodontic Therapy and Regenerative Periodontal Surgery in Advanced Periodontitis Patients With Pathologic Tooth Migration
Official Title
The Effect of Timing of Orthodontic Therapy on the Outcomes of Regenerative Periodontal Surgery in Patients With Advanced Periodontitis and Pathologic Tooth Migration. A Multi Centre Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
July 22, 2020 (Actual)
Study Completion Date
March 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bonn
Collaborators
Universidad Complutense de Madrid
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pathologic tooth migration (PTM) is a common complication of advanced periodontitis and often motivation for patients to seek orthodontic therapy. An interdisciplinary approach is required to control the periodontal infection, reconstruct the defects and realign the migrated teeth. The optimal timing of active orthodontics after regenerative therapy is a topic of ongoing debate.
There are no data available from RCTs that have compared the effect of the timing of orthodontic tooth movement (early vs. late) on the outcomes of regenerative periodontal surgery in these patients.
It is the aim of the present randomized clinical multicenter trial to compare 2 different treatment protocols of a combined perio-regenerative and orthodontic therapy in advanced periodontitis patients with intrabony defects and pathologic tooth migration in order to establish whether one treatment modality is superior to the other with regard to clinical outcomes. A total of 46 patients will be enrolled and randomized into 2 treatment groups that differ by the time point of initiation of orthodontic therapy (early: 4 weeks vs. late: 6 months following regenerative periodontal surgery).
Primary outcome measure will be the change in clinical attachment level (CAL gain) at 12 months after regenerative therapy. Secondary outcomes will include changes in probing depth BOP, gingival recession, radiographic bone height and patient-centered outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Tooth Migration, Intrabony Periodontal Defect
Keywords
Pathological tooth migration, periodontal regenerative surgery, vertical infrabony defects, xenogeneic bone graft, orthodontic therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ParS+Ortho 4W
Arm Type
Experimental
Arm Description
Orthodontic alignment starts 4 weeks post surgical
Arm Title
ParS+Ortho 6M
Arm Type
Active Comparator
Arm Description
Orthodontic alignment starts 6 months post surgical
Intervention Type
Procedure
Intervention Name(s)
ParS+Ortho 4W
Intervention Description
Orthodontics 4 weeks post surgical
Intervention Type
Procedure
Intervention Name(s)
ParS+Ortho 6M
Intervention Description
Orthodontics 6 months post surgical
Primary Outcome Measure Information:
Title
Clinical attachment level (CAL) at test site
Description
Clinical attachment level (CAL)measurements 12 months after surgery
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Probing depth (PD) at test site
Description
Probing depth (PD) )measurements 12 and 24 months after surgery
Time Frame
24 months
Title
Mean probing depth (PD)
Description
Mean probing depth (PD) )measurements 12 and 24 months after surgery
Time Frame
24 months
Title
Bleeding on Probing (BoP) at test site
Description
Bleeding on Probing (BoP) measurements 12 and 24 months after surgery
Time Frame
24 months
Title
Mean bleeding on Probing (BoP)
Description
Mean Bleeding on Probing (BoP) measurements 12 and 24 months after surgery
Time Frame
24 months
Title
Plaque (PI) at test site
Description
Plaque (PI) measurements 12 and 24 months after surgery
Time Frame
24 months
Title
Mean Plaque (PI)
Description
Plaque (PI) measurements 12 months after surgery
Time Frame
24 months
Title
Mean clinical attachment level (CAL)
Description
Mean clinical attachment level (CAL)12 months after surgery
Time Frame
24 months
Title
PROMS
Description
Patient reported Outcomes
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Advanced periodontitis
Presence of intrabony defects at a minimum of 2 and a maximum of 7 adjacent teeth (positions 15-25 or 35-45) in either the maxilla or the mandible with PPD of ≥6 mm at a minimum on one site
Pathologic tooth migration
Full mouth plaque index (PI) <25% at baseline (after initial non-surgical periodontal therapy)
Full mouth bleeding on probing (FMBP) <25% at baseline (i.e., following initial non-surgical periodontal therapy)
Committed to the study and the required follow-up visits
Exclusion Criteria:
Any contraindications for oral surgical procedures
Uncontrolled diabetes or other uncontrolled systemic diseases
Disorders or treatments that compromise wound healing
Medical conditions requiring chronic high dose steroid therapy
Bone metabolic diseases
Radiation or other immuno-suppressive therapy
Infections or vascular impairment at the surgical site
Presence of oral lesions (such as ulceration, malignancy) or mucosal diseases
History of malignant disease in the oral cavity or previous radiotherapy to the head
Inadequate oral hygiene or unmotivated for adequate home care
Current smokers > 6Cig
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren Jepsen, Phd
Organizational Affiliation
Director
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Karin Jepsen, Dr
Organizational Affiliation
OA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas Jaeger, Phd
Organizational Affiliation
Director
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Conchita Martin, PhD
Organizational Affiliation
Faculty of Odontology, UCM
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mariano Sanz, PhD
Organizational Affiliation
Faculty of Odontology, UCM
Official's Role
Study Chair
Facility Information:
Facility Name
Poliklinik für Parodontologie, Zahnerhaltung und Präventive Zahnheilkunde
City
Bonn
State/Province
North Rhine-Westphalia
ZIP/Postal Code
53111
Country
Germany
Facility Name
Master de Periodoncia Universidad Complutense
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
4532114
Citation
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Results Reference
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Timing of Orthodontic Therapy and Regenerative Periodontal Surgery in Advanced Periodontitis Patients With Pathologic Tooth Migration
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