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

Periodontitis, Aggressive Clinical Trial

Official title:

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: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03340012
• Other study ID #: WUM.PERIO.02
• Status: Not yet recruiting
• Phase: N/A
• First received: November 8, 2017
• Last updated: November 9, 2017
• Start date: January 5, 2018
• Est. completion date: May 5, 2019

Study information

• Verified date: November 2017
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 5, 2019
• Est. primary completion date: May 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Aggressive Periodontitis
• Periodontitis
• Periodontitis, Aggressive

Intervention

Device:
• 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)

Locations

Country	Name	City	State
Poland	Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw	Warsaw	Mazowsze

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinical attachment level (CAL)	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.	Baseline and 12 months after surgery