Status:
COMPLETED
Comparison of the GTR Procedure Alone and in Combination With Immediate OTM
Lead Sponsor:
Semmelweis University
Collaborating Sponsors:
Schupbach Ltd.
Geistlich Pharma AG
Conditions:
Intrabony Periodontal Defect
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The aim is to evaluate in a prospective, randomized, controlled clinical study the healing of a GTR procedure, when it is combined with an immediate orthodontic tooth movement or used alone. Clinical,...
Detailed Description
There is limited histological data in literature on the behavior of xenogeneic graft materials in intrabony defects used in periodontal regenerative therapy followed by orthodontic tooth movement (OTM...
Eligibility Criteria
Inclusion
- Periodontitis with intrabony defect (Intrabony component ≥ 4mm, defect radiological angulation \> 25°, 1 or max. 2 bony walls (no buccal bony wall), non-containing defect), no class III. furcation involved teeth
- Selected tooth must be in a traumatic occlusion or not in a gnathologically correct bite (migrated, elongated, tilted tooth, etc.).
- Patients must not be heavy smokers (\<5 cigarettes/day).
- Full mouth plaque and bleeding scores (FMPS and FMBS) of \<20% (O'Leary et al. 1972).
- The patient is able to comply with the study -related procedures (i.e. good level of oral hygiene, follow-up procedures).
- The patient is able to fully understand the nature of the study, signed informed consent.
Exclusion
- Pregnant women.
- Participation in another clinical study within 30 days prior to study start.
- Alcoholism, drug dependency, heavy smoking (\>5 cigarettes/day).
- Known infection with HIV, HBV, or HCV.
- Patients requiring chemo- or radiotherapy.
- Previous or current radiotherapy of the head.
- Uncontrolled or insulin-dependent diabetes mellitus
- Clinically relevant osteoporosis or systemic disease affecting bone metabolism
- Clinically relevant cardiovascular disease e.g., decompensated cardiac insufficiency, hemodynamically relevant heart valve defects, or myocardial infarction during the last three months.
- Clinically relevant blood coagulation disorder.
- Previous or current treatment with systemic corticosteroids (within 2 months prior to screening visit) of more than 5 mg/day prednisone equivalent.
- Previous or current therapy with bisphosphonates at least for 30 days within the last 12 months before screening visit.
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04896450
Start Date
September 1 2015
End Date
December 1 2022
Last Update
February 21 2023
Active Locations (1)
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1
Semmelweis University Department of Periodontology
Budapest, Hungary, 1088