Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
5 participants
INTERVENTIONAL
2019-10-15
2023-11-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Regenerative therapy w/BCP and collagen membrane
In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and collagen membrane.
Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane)
Device: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane) Following open flap debridement of mandibular grade II furcation defects, regenerative therapy is performed with biphasic calcium phosphate + collagen membrane.
Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)
Drug: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain) Following open flap debridement of mandibular grade II furcation defects, regenerative therapy is performed with biphasic calcium phosphate + enamel matrix proteins.
Regenerative therapy w/BCP and enamel matrix proteins
In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and enamel matrix proteins.
Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane)
Device: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane) Following open flap debridement of mandibular grade II furcation defects, regenerative therapy is performed with biphasic calcium phosphate + collagen membrane.
Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)
Drug: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain) Following open flap debridement of mandibular grade II furcation defects, regenerative therapy is performed with biphasic calcium phosphate + enamel matrix proteins.
Interventions
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Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane)
Device: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane) Following open flap debridement of mandibular grade II furcation defects, regenerative therapy is performed with biphasic calcium phosphate + collagen membrane.
Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)
Drug: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain) Following open flap debridement of mandibular grade II furcation defects, regenerative therapy is performed with biphasic calcium phosphate + enamel matrix proteins.
Eligibility Criteria
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Inclusion Criteria
* Subject must have periodontal disease as determined by the World Workshop 2017 criteria
* Subjects must be undergoing periodontal treatment or follow-up and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade II with PPD \>4 mm, and the furcation fornix must be below a tangential line from the distal to mesial interproximal crestal bone level
* Competent to give consent
Exclusion Criteria
* Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment
* Present or past use of bisphosphonate treatment
* Pregnant or nursing subjects
* Patients classified as \> class 2 according to the ASA (American Society of Anesthesiologists) physical status classification
* Previous surgical therapy of included furcation defects
* Inability to comprehend and respond to the quality of life questionnaire
* Dental restorations or prosthesis involving the furcation area
* Root fractures or suspected infractions
* Caries lesions in the furcation area
* No systemic antibiotic treatment within 3 months prior to intervention
20 Years
ALL
Yes
Sponsors
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University of Oslo
OTHER
Responsible Party
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Anders Verket
Associate Professor
Locations
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Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo
Oslo, , Norway
Countries
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Other Identifiers
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FURC-III-REGEN
Identifier Type: -
Identifier Source: org_study_id