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Trial record 88 of 119 for:    ZIRCONIUM

Soft Peri-implant Tissue Around Different Abutment Materials

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ClinicalTrials.gov Identifier: NCT03459547
Recruitment Status : Not yet recruiting
First Posted : March 9, 2018
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
Max-Planck Institute of Molecular Cell Biology and Genetics
Information provided by (Responsible Party):
Andrea Pilloni MD DDS MS, University of Roma La Sapienza

Brief Summary:

Soft tissue attachment to the implant surface serves as a biological seal preventing the development of inflammatory periimplant diseases (i.e. peri-implant mucositis and peri-implantitis).It occurs in the presence of a biomaterial during healing of the surgical wound that might be influence by this foreign body. Myofibroblasts represent key players in the physiological reconstruction of connective tissue after injury.

This work will focus on the role of myofibroblasts during the early phases of the healing process in peri-implant tissues around four different abutment materials.


Condition or disease Intervention/treatment Phase
Dental Implant Failure Nos Wound Heal Device: dental implant Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients of more than 18 years old without systemic disease/ disorders, smokers of less 5 cigarettes per day, periodontally healthy or treated with full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 15% at baseline with edentulous space needing an all on four or all on six treatment with overdenture width of the keratinized gingiva ≥ 2 at the level of the crest
Masking: Double (Participant, Investigator)
Masking Description: double-blind
Primary Purpose: Diagnostic
Official Title: Features of Peri-implant Soft Tissue Early Healing Around Different Abutment Materials
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
Experimental: dental implant + PEEK (test)
Dental implant insertion, material polyetheretherketone
Device: dental implant
Local anesthesia, flap preparation, dental implant insertion, flap suture, healing abutment insertion. Peri-implant soft tissue samples taken prior to implant placement and 24 hours after.
Other Names:
  • PEEK
  • Ti-4
  • Ti-5
  • zirconia

Active Comparator: dental implant + Ti-5 (control)
Dental implant insertion, material titanium group 5
Device: dental implant
Local anesthesia, flap preparation, dental implant insertion, flap suture, healing abutment insertion. Peri-implant soft tissue samples taken prior to implant placement and 24 hours after.
Other Names:
  • PEEK
  • Ti-4
  • Ti-5
  • zirconia

Active Comparator: dental implant + zirconia (control)
dental implant insertion, material zirconia
Device: dental implant
Local anesthesia, flap preparation, dental implant insertion, flap suture, healing abutment insertion. Peri-implant soft tissue samples taken prior to implant placement and 24 hours after.
Other Names:
  • PEEK
  • Ti-4
  • Ti-5
  • zirconia

Active Comparator: dental implant + Ti-4 (control)
dental implant insertion, material titanium group 4
Device: dental implant
Local anesthesia, flap preparation, dental implant insertion, flap suture, healing abutment insertion. Peri-implant soft tissue samples taken prior to implant placement and 24 hours after.
Other Names:
  • PEEK
  • Ti-4
  • Ti-5
  • zirconia




Primary Outcome Measures :
  1. Early healing of peri-implant soft tissues [ Time Frame: 24 hours ]
    The early healing of soft peri-implant tissues will be interpreted through the activity of myofybroblasts



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Absence of Systemic Diseases / Disorders
  • Smoking ≤ 5 cigarettes per day
  • Periodontally healthy or treated
  • Full-mouth plaque score (FMPS) ≤ 15% at baseline
  • Full-mouth bleeding score (FMBS) ≤ 15% at baseline
  • Presence of edentulous space needing an all on four or all on six treatment with overdenture
  • Width of the keratinized gingiva ≥ 2 at the level of the crest

Exclusion Criteria:

(I) • Pregnancy / lactation

  • Use of systemic antibiotics in the last 3 months
  • Use of systemic antibiotics as prophylaxis for endocarditis
  • A chronically treated patient (i.e. 2 weeks or longer) with medicines known to affect periodontal tissues (e.g. phenytoin, calcium antagonists, cyclosporine, warfarin and non-steroidal anti-inflammatory drugs) the last month before starting the study
  • Radiotherapy in the neck-head region
  • HIV, TB, hepatitis or other infectious diseases
  • Abuse with drugs or alcohol
  • Smoked cigarettes> 5 cigarettes per day
  • Untreated periodontitis
  • FMPS> 15% at baseline
  • FMBS> 15% at baseline
  • Implants with peri-implant history
  • Width of keratinized tissue over crest <2 mm
  • Need for bone reconstruction around implants to be inserted

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): NCT03459547


Contacts
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Contact: Andrea Pilloni, MD DDS MS 335/6409374 ext 0039 andrea.pilloni@uniroma1.it

Sponsors and Collaborators
University of Roma La Sapienza
Max-Planck Institute of Molecular Cell Biology and Genetics
Investigators
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Principal Investigator: Andrea Pilloni, MD DDS Ms Sapienza University of Rome

Publications:
Lindhe J, Wennstrom JL & Berglundh T. The mucosa at teeth and implants. In: Lindhe, J., Lang, N. P. & Karring, T. (eds). Clinical Periodontology and Implant Dentistry, 5th edition, pp. 69-85, 2008.

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Responsible Party: Andrea Pilloni MD DDS MS, MD DDS MS, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03459547     History of Changes
Other Study ID Numbers: 0000102
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
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
Product Manufactured in and Exported from the U.S.: No