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

Medical University of Warsaw

Status: Unknown

Conditions: Periodontitis, Aggressive

Treatments: Device: GTR + radiation-sterilize allogenic bone graft; Device: GTR + xenogenic graft

Study type: Interventional

Funder types: Other

Identifiers

NCT03340012

WUM.PERIO.02

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

GTR + radiation-sterilize allogenic bone graft (TEST)

Experimental group

Description:

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.

Treatment:

Device: GTR + radiation-sterilize allogenic bone graft

GTR + xenogenic graft (CONTROL)

Active Comparator group

Description:

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.

Treatment:

Device: GTR + xenogenic graft