Clinical and Radiographic Evaluation of Guided Tissue Regeneration With Radiation-sterilized Allogenic Bone Grafts or Xenogenic Grafts for the Treatment of Intrabony Defects in Aggressive Periodontitis
NCT ID: NCT03340012
Last Updated: 2017-11-13
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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UNKNOWN
NA
20 participants
INTERVENTIONAL
2018-01-05
2019-05-05
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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GTR + radiation-sterilize allogenic bone graft (TEST)
The surgical procedure will be performed in line with minimally invasive surgical technique by Cortellini and Tonetti (2007). The intrabony defects will be debrided and the roots will be planned. The required quantity of radiation-sterilized allogenic bone graft will be delivered into intrabony defects. Subsequently, a trimmed collagen membrane will be placed over graft. The flaps will be sutured with non-absorbable modified internal mattress sutures.
GTR + radiation-sterilize allogenic bone graft
Guided tissue regeneration of intrabony defects with collagen membrane (Bio-Gide® Perio, Geistlich Biomaterials) and radiation-sterilized allogenic bone graft from the Central Tissue Bank in Warsaw
GTR + xenogenic graft (CONTROL)
The surgical procedure will be performed in line with minimally invasive surgical technique by Cortellini and Tonetti (2007). The intrabony defects will be debrided and the roots will be planned. The required quantity of xenogenic graft will be delivered into intrabony defects. Subsequently, a trimmed collagen membrane will be placed over graft. The flaps will be sutured with non-absorbable modified internal mattress sutures.
GTR + xenogenic graft
Guided tissue regeneration of intrabony defects with collagen membrane (Bio-Gide® Perio, Geistlich Biomaterials) and xenogenic graft (Bio-Oss®, Geistlich Biomaterials)
Interventions
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GTR + radiation-sterilize allogenic bone graft
Guided tissue regeneration of intrabony defects with collagen membrane (Bio-Gide® Perio, Geistlich Biomaterials) and radiation-sterilized allogenic bone graft from the Central Tissue Bank in Warsaw
GTR + xenogenic graft
Guided tissue regeneration of intrabony defects with collagen membrane (Bio-Gide® Perio, Geistlich Biomaterials) and xenogenic graft (Bio-Oss®, Geistlich Biomaterials)
Eligibility Criteria
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Inclusion Criteria
* Familial aggregation (history of periodontitis in parents or siblings)
* Presence of at least two teeth with probing pocket depth (PPD) ≥ 6mm and clinical attachment level (CAL) ≥ 5 mm associated with an intrabony defect of at least 3 mm as detected in diagnostic periapical radiographs
* No furcation involvement of the teeth presenting the intraosseous defects
* The width of keratinized tissue on the facial aspect of the selected teeth ≥ 2 mm
Exclusion Criteria
* Full-mouth sulcus bleeding index ≥ 15% (Mühlemann \& Son 1971)
* Smoking more than 10 cigarettes/day
* Systemic diseases with compromised healing potential of infectious diseases
* Drugs affecting periodontal health / healing
* Pregnant and lactating females
* Previous periodontal surgery in the area
18 Years
60 Years
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Responsible Party
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Locations
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Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
Warsaw, Mazowsze, Poland
Countries
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Facility Contacts
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Batlomiej Gorski, DDS, PhD
Role: primary
Other Identifiers
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WUM.PERIO.02
Identifier Type: -
Identifier Source: org_study_id