Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Autologous Alveolar Bone Marrow Mesenchymal Stem Cells for the Reconstruction of Infrabony Periodontal Defects (PerioRegen)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02449005
Recruitment Status : Completed
First Posted : May 20, 2015
Last Update Posted : November 1, 2018
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
Danae A. Apatzidou, Aristotle University Of Thessaloniki

Brief Summary:
Systemically healthy periodontitis patients are recruited from new referrals to the Department of Periodontology and Biology of Implants, AUTh. After completion of non-surgical periodontal treatment those subjects who have at least one interdental osseous defect with probing pocket depth and clinical attachment level of ≥ 6mm and an intrabony component of ≥ 3mm with no endodontic or furcation involvement are randomly allocated into one of the three treatment groups. Group A receives regenerative treatment using autologous bone marrow mesenchymal stem cells free of animal derived reagents, produced in clean room facilities and seeded into collagen scaffolds enriched with fibrin glue; in Group B, a collagen fleece enriched with fibrin glue devoid of stem cells fills the osseous defect; Group C receives open flap debridement retaining the soft wall of the defect. Thereafter, subjects are followed for 12 months and are repeatedly assessed based on clinical, radiographic, immunological and microbiological parameters.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Biological: BM-MSCs/fibrin glue/collagen fleece Other: Fibrin glue/collagen fleece Procedure: Open flap debridement Phase 1 Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The participant, care provider, investigator/outcome assessor is not aware of the treatment modality
Primary Purpose: Treatment
Official Title: A Phase I/II Double-Blind Randomised Controlled Clinical Trial To Study The Safety and Efficacy Of A Novel Regenerative Treatment Of Infrabony Periodontal Defects Using Autologous Alveolar Bone-Marrow Mesenchymal Stem Cells (aBM-MSCs).
Actual Study Start Date : March 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Experimental: Group A
Group A (BM-MSCs/fibrin glue/collagen fleece) will receive regenerative treatment using autologous bone marrow mesenchymal stem cells free of animal derived reagents, produced in clean room facilities and seeded into collagen scaffolds enriched with autologous fibrin glue
Biological: BM-MSCs/fibrin glue/collagen fleece
Xeno-free, clinical-grade, autologous alveolar bone marrow mesenchymal stem cells enriched with autologous fibrin glue and loaded into a commercially available collagen fleece.

Experimental: Group B
in Group B (Fibrin glue/collagen fleece), a collagen fleece enriched with autologous fibrin glue devoid of stem cells will fill the osseous defect
Other: Fibrin glue/collagen fleece
The biocomplex of autologous fibrin glue and collagen fleece devoid of stem cells will fill the osseous defect
Other Name: Procedure/Surgery/Growth factors

Active Comparator: Group C
Group C will receive open flap debridement retaining the soft tissue wall of the pocket
Procedure: Open flap debridement
Group C will receive minimally invasive surgery employing papilla preservation techniques in addition to retaining the soft tissue wall of the pocket. There will be no use of grafting materials




Primary Outcome Measures :
  1. A reduction in the distance in mm from the bottom of the periodontal pocket to the cementoenamel junction using a manual probe (Hu-Friedy XP-23/QW, Hu-Friedy, Chicago, IL, USA) with 20-25g of pressure by a single calibrated examiner. [ Time Frame: up to 12- months ]
    Clinical data (gain in clinical attachment level (CAL))


Secondary Outcome Measures :
  1. A reduction in the distance in mm between the gingival margin and the bottom of the defect using a manual periodontal probe (Hu-Friedy XP-23/QW) by a single calibrated examiner. [ Time Frame: up to 12-months (baseline, 6-, 9-, 12- months) ]
    Clinical data (reduction in probing pocket depth (PPD))


Other Outcome Measures:
  1. A change in the distance in mm between the cementoenamel junction and the bottom of defect will be determined using a single evaluator. [ Time Frame: Baseline, 6-weeks & 3-, 6-, 9-, 12- months ]
    Radiographic data (CEJ-BD change)

  2. A change in the distance in mm between the bone crest to bottom of defect will be determined using a single evaluator. [ Time Frame: Baseline, 6-weeks & 3-, 6-, 9-, 12- months ]
    Radiographic data (BC-BD change)

  3. Composite measure of biomarkers will be examined to evidence the healing and immune response during the observation period [ Time Frame: Baseline, 6-weeks & 3-, 6-, 9-, 12- months ]
    Immunological data; changes

  4. Clinical measurements after surgical debridement of the area will determine the morphology of the osseous defect [ Time Frame: Baseline ]
    Intrasurgical clinical data (CEJ-BD; BC-BD; width of the defect; number of bone walls)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Following non-surgical periodontal treatment, advanced chronic periodontitis patients, who are able to maintain plaque scores of less than 25% and have at least one deep infrabony defect with PPD and CAL of ≥ 6mm and an infrabony component of ≥ 3mm with no endodontic or furcation involvement as detected on the radiographs will be scheduled for surgery and will be followed for 12 months.

Exclusion Criteria:

  • Exclusion criteria: poorly controlled systemic disease, heavy smoking (>20cigs/day), drug induced gingival hyperplasia, bisphosphonate medication, anti-inflammatory drugs, bone metabolic diseases or disorders that compromise wound healing, immunosuppressive therapy or radiation, alcohol intake, drug abuse over the past year, significant concurrent illness, pregnancy/lactation, poor compliance during the initial phase of treatment, compromised oral hygiene (PI ≥25%).

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): NCT02449005


Locations
Layout table for location information
Greece
Dental School, Aristotle University
Thessaloniki, Greece, 54124
Sponsors and Collaborators
Aristotle University Of Thessaloniki
University of Glasgow
Investigators
Layout table for investigator information
Study Chair: Antonis Konstantinidis, Professor Dept. of Periodontology and Implant Biology, School of Dentistry, Aristotle University of Thessaloniki

Publications:
Layout table for additonal information
Responsible Party: Danae A. Apatzidou, Assistant Professor, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT02449005     History of Changes
Other Study ID Numbers: ELKE-90467
First Posted: May 20, 2015    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Danae A. Apatzidou, Aristotle University Of Thessaloniki:
regeneration
stem cells
infrabony periodontal defect
fibrin glue
collagen fleece

Additional relevant MeSH terms:
Layout table for MeSH terms
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Fibrin Tissue Adhesive
Hemostatics
Coagulants