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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

Primary Purpose

Periodontitis, Aggressive

Status

Unknown status

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

GTR + radiation-sterilize allogenic bone graft

GTR + xenogenic graft

About this trial

This is an interventional treatment trial for Periodontitis, Aggressive

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GTR + radiation-sterilize allogenic bone graft (TEST)

GTR + xenogenic graft (CONTROL)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03340012

First Posted

November 8, 2017

Last Updated

November 9, 2017

Sponsor

Medical University of Warsaw

1. Study Identification

Unique Protocol Identification Number

NCT03340012

Brief 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

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 5, 2018 (Anticipated)

Primary Completion Date

May 5, 2019 (Anticipated)

Study Completion Date

May 5, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of Warsaw

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontitis, Aggressive

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GTR + radiation-sterilize allogenic bone graft (TEST)

Arm Type

Experimental

Arm Description

Arm Title

GTR + xenogenic graft (CONTROL)

Arm Type

Active Comparator

Arm 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.

Intervention Type

Device

Intervention Name(s)

GTR + radiation-sterilize allogenic bone graft

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

GTR + xenogenic graft

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Clinical attachment level (CAL)

Description

Time Frame

Baseline and 12 months after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

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

City

Warsaw

State/Province

Mazowsze

ZIP/Postal Code

00-246

Country

Poland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Batlomiej Gorski, DDS, PhD

Phone

+48 22 502 20 99

12. IPD Sharing Statement

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