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Status unknownNCT03340012Updated Nov 13, 2017

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

An interventional study of GTR + radiation-sterilize allogenic bone graft and GTR + xenogenic graft in Periodontitis, Aggressive, sponsored by Medical University of Warsaw. Status unknown at 1 site in Poland. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-11-13.

Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Periodontitis, Aggressive
03

In context

Aggressive Periodontitis

63 studies on the registry are indexed under Aggressive Periodontitis; 5 are open to participants now.

This study's planned enrollment of 20 is below the median of 34 across 41 interventional studies indexed under Aggressive Periodontitis.

Browse Aggressive Periodontitis studies →

Lead sponsor

Medical University of Warsaw is the lead sponsor of 326 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    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.

    Device: GTR + radiation-sterilize allogenic bone graft

  • Active comparator
    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.

    Device: GTR + xenogenic graft

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)

06

What researchers measure

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.

    Time frame: Baseline and 12 months after surgery

07

Study locations

1 site
  • Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
    Warsaw, Mazowsze 00-246, Poland
    • Batlomiej Gorski, DDS, PhD · Contact+48 22 502 20 99
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03340012
Responsible party
Sponsor
First posted
Nov 13, 2017
Start date
Jan 5, 2018 (estimated)
Primary completion
May 5, 2019 (estimated)
Completion
May 5, 2019 (estimated)
Last update
Nov 13, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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