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Evaluation of Enamel Matrix Derivative as an Adjunct to Minimally Invasive Non-surgical Treatment of Intrabony Defects.

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ClinicalTrials.gov Identifier: NCT03622255
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Ioannis Vouros, Aristotle University Of Thessaloniki

Brief Summary:

Aim:

The aim of this prospective, randomized, parallel arm, blind, controlled clinical trial is to compare the clinical and radiographic outcomes following regenerative treatment of intrabony periodontal defects using a Minimally Invasive Non-Surgical Technique (MINST) with or without the application of Enamel Matrix Derivative (EMD)

Research Hypothesis:

The hypothesis is that the adjunctive application of EMD will enhance the clinical and radiographic results of minimally invasive non- surgical treatment of intrabony defects. Radiographic bone fill will be the primary outcome of the research, whereas CAL gain and PD reduction will constitute the secondary outcomes.


Condition or disease Intervention/treatment Phase
Periodontal Diseases Procedure: MINST Procedure: MINST with EMD Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A software (www.randomizer.org) will be used by one of the investigators who will not participate in the clinical and radiographic measurements nor the therapeutic intervention, to generate a block randomization. Thus, participants will be randomized in one of the two groups in a way that there is no difference between the two groups regarding the initial depth of the intrabony defect. In patients with more than one intrabony defects meeting the inclusion criteria, a second randomization scheme with the same software will take place, to determine which will be included. The randomization results will be placed in sealed envelopes accessible only to the principal investigator and opened for each patient after the end of MINST to determine if EMD will be applied or not.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Enamel Matrix Derivative as an Adjunct to Minimally Invasive Non-surgical Treatment of Intrabony Defects. A Randomized Controlled Clinical Trial.
Actual Study Start Date : May 5, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Arm Intervention/treatment
MINST
Minimally invasive non-surgical technique (MINST): Root instrumentation under local anesthesia using specific hand instruments (micro- curettes) and delicate piezon ultrasonic instruments in the area of intraosseous defect.
Procedure: MINST
Minimally invasive non-surgical technique (MINST) for the treatment of intrabony defects has been compared with minimally invasive surgical treatment of these defects and has shown to achieve similar beneficial clinical results. In this study MINST will be used as the control treatment.

Active Comparator: MINST with EMD
Minimally invasive non-surgical technique (MINST) with application of Enamel Matrix Derivative (EMD): Root instrumentation under local anesthesia using micro- curettes and delicate piezon ultrasonic instruments in the area of intraosseous defect. Experimental intervention by application of EDTA gel for 2 minutes on the root surface of the involved tooth, followed by rinsing with saline, drying and application of Enamel Matrix Derivative gel, to fill the defect.
Procedure: MINST with EMD
Enamel matrix derivative (EMD) has been widely used in the surgical treatment of periodontal intrabony defects, using a minimally invasive surgical technique (MINST). Recent studies have suggested that this product could also be used in the non-surgical treatment of intrabony defects using a minimally invasive technique with very good results. This study will evaluate the effect of enamel matrix derivative in the non-surgical treatment of periodontal intrabony defects when a minimally invasive technique is used. Besides clinical measurements, radiographic analysis will also be performed to evaluate the treatment results.




Primary Outcome Measures :
  1. Radiographic bone fill [ Time Frame: Change from baseline to 12 months ]
    Bone level in the intrabony defect


Secondary Outcome Measures :
  1. Clinical attachment gain [ Time Frame: Change from baseline to 12 months ]
    Clinical attachment level of intrabony defect measured in millimeters

  2. Pocket depth reduction [ Time Frame: Change from baseline to 12 months ]
    Pocket depth of intrabony defect measured in millimeters


Other Outcome Measures:
  1. Recession [ Time Frame: Change from baseline to 12 months ]
    Recession depth calculated as the difference of clinical attachment level minus probing depth.

  2. Full mouth plaque score [ Time Frame: Change from baseline to 12 months ]
    Percentage of tooth sites with detectable plaque

  3. Full mouth bleeding score [ Time Frame: Change from baseline to 12 months ]
    Percentage of tooth sites with bleeding when a periodontal probe is traced along the gingival margin

  4. Distance from the CEJ or the margin of a restoration to the bottom of the defect (CEJ-BD) [ Time Frame: Change from baseline to 12 months ]
    Measured in millimeters

  5. Distance from the Cementoenamel Junction to the bone crest (CEJ-BC) [ Time Frame: Change from baseline to 12 months ]
    Measured in millimeters

  6. Depth of the intraosseous defect [ Time Frame: Change from baseline to 12 months ]
    Distance from the bone crest to the bottom of the defect (BC-BD) measured in millimeters

  7. Angle of the intraosseous defect [ Time Frame: Change from baseline to 12 months ]
    Angle will be determined by the line defined by the root surface of the involved tooth and the line defined by the bone wall of the defect



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be at least 18 years of age with a diagnosis of periodontitis.
  • Have at least one isolated interproximal intrabony defect on a single-rooted tooth or a mandibular molar not extending to the furcation area with radiographic depth ranging between 3 mm-7 mm, pocket depth and clinical attachment loss ≥6 mm and radiographic defect angle ≤ 35o
  • Proper oral hygiene: full-mouth plaque score (FMPS) ≤20% και full-mouth bleeding score (FMBS) ≤20%
  • Systemically healthy (absence of systemic conditions that can affect the treatment outcome of periodontal therapy)

Exclusion Criteria:

  • Pregnant or lactating female
  • Current acute infection
  • Non- surgical periodontal treatment the last 6 months or surgical periodontal treatment the last 12 months
  • Teeth having an improper endodontic therapy with clinical signs of infection or subgingival restorations
  • Tooth mobility 2nd- 3rd degree
  • History of radiation therapy in the head and neck region

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): NCT03622255


Contacts
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Contact: Ioannis Vouros, DDS, Ph.D +306932907030 jvou@med.auth.gr
Contact: Styliani Anoixiadou, DDS +306948318588 stella.anoix@gmail.com

Locations
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Greece
Aristotle University of Thessaloniki, School of Dentistry Recruiting
Thessaloníki, Thessaloniki, Greece, 54124
Contact: Ioannis Vouros, DDS, Ph.D    +306932907030    jvou@med.auth.gr   
Contact: Styliani Anoixiadou, DDS    +306948318588    stella.anoix@gmail.com   
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
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Principal Investigator: Ioannis Vouros, DDS, Ph.D Aristotle University Of Thessaloniki

Publications:

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Responsible Party: Ioannis Vouros, Professor, Department of Preventive Dentistry, Periodontology and Implant Biology, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT03622255     History of Changes
Other Study ID Numbers: 09/23-11-2017
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Ioannis Vouros, Aristotle University Of Thessaloniki:
Intrabony defects
Minimally invasive non-surgical technique
Enamel Matrix Derivative

Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases