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

NCT03340012 | Unknown

• 1 other identifier: WUM.PERIO.02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis, Aggressive

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

GTR + radiation-sterilize allogenic bone graft (TEST)

EXPERIMENTAL

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.

Device: GTR + radiation-sterilize allogenic bone graft

GTR + xenogenic graft (CONTROL)

ACTIVE COMPARATOR

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.

Device: GTR + xenogenic graft

Interventions

GTR + radiation-sterilize allogenic bone graft DEVICE

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 + radiation-sterilize allogenic bone graft (TEST)

GTR + xenogenic graft DEVICE

Guided tissue regeneration of intrabony defects with collagen membrane (Bio-Gide® Perio, Geistlich Biomaterials) and xenogenic graft (Bio-Oss®, Geistlich Biomaterials)

GTR + xenogenic graft (CONTROL)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw

Warsaw, Mazowsze, 00-246, Poland

Location

MeSH Terms

Conditions

Aggressive Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: January 5, 2018
• Primary Completion: May 5, 2019
• Study Completion: May 5, 2019
• Last Updated: November 13, 2017

Record last verified: 2017-11

Locations

PL (1)