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Trial record 8 of 106 for:    Recruiting, Not yet recruiting, Available Studies | "Bone Transplantation"

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

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ClinicalTrials.gov Identifier: NCT03340012
Recruitment Status : Not yet recruiting
First Posted : November 13, 2017
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw

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.

Condition or disease Intervention/treatment Phase
Periodontitis, Aggressive Device: GTR + radiation-sterilize allogenic bone graft Device: GTR + xenogenic graft Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 5, 2018
Estimated Primary Completion Date : May 5, 2019
Estimated Study Completion Date : May 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
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
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

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




Primary Outcome Measures :
  1. Change in Clinical attachment level (CAL) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340012


Locations
Poland
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw Not yet recruiting
Warsaw, Mazowsze, Poland, 00-246
Contact: Batlomiej Gorski, DDS, PhD    +48 22 502 20 99      
Sponsors and Collaborators
Medical University of Warsaw

Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03340012     History of Changes
Other Study ID Numbers: WUM.PERIO.02
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Periodontitis
Aggression
Aggressive Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms