Periodontitis, Aggressive
Conditions
Brief summary
The treatment of intrabony defects in patients with aggressive periodontitis remains a challenging procedure and novel therapeutic strategies are sought. The purpose of this study is to compare the clinical and radiographic outcomes of using guided tissue regeneration (GTR) with radiation-sterilized allogenic bone grafts (material prepared in the Central Tissue Bank in Warsaw, Poland) versus guided tissue regeneration with xenogenic grafts (Bio-Oss®, Geistlich Biomaterials, Princeton, New Jersey, United States) in the treatment of localized intrabony defects in patients with aggressive periodontitis.
Interventions
DEVICEGTR + 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
DEVICEGTR + xenogenic graft
Guided tissue regeneration of intrabony defects with collagen membrane (Bio-Gide® Perio, Geistlich Biomaterials) and xenogenic graft (Bio-Oss®, Geistlich Biomaterials)
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of aggressive periodontitis in line with American Academy of Periodontology classification (Lang et al. 1999) * 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 plaque index ≥ 20% (Ainamo & Bay 1975) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical attachment level (CAL) | Baseline and 12 months after surgery | CAL will be measured in millimeters on the study teeth at 6 locations as a distance from the cementoenamel junction to the bottom of the gingival sulcus. The average differences between 12 months and baseline measurements at the sites with the most advanced attachment loss at baseline will be compared. |
Countries
Poland
Outcome results
None listed