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Periimplant Mucosa Dynamics Around Divergent and Concave Atlantis Abutment Transition Profiles

19. maj 2022 opdateret af: Christopher Barwacz

Peri-implant Mucosa Dynamics Around Divergent and Concave Atlantis™ Abutment Transition Profiles.

The purpose of this study is to compare the effect of two different implant abutment designs on gum tissue volume changes over time after implant placement.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a randomized, prospective, controlled clinical trial comparing the facial gingival profiles around Atlantis™ abutments that have either a linear "divergent" or "concave" transitional profile on the facial and proximal aspect of the abutments.

Sixty study subjects requiring replacement of a single-rooted tooth with an implant-supported restoration will be recruited.

The Osseospeed™ Plus implant will be placed for all 60 subjects, with the use of Uni healing abutments to minimize lateral tissue displacement during healing. After implant placement, but before final impressions are obtained (8 weeks post-placement), subjects will be randomized to either a "divergent" or a "concave" transmucosal abutment design. For fabrication of the experimental abutment, Atlantis™ engineers will initially design a control "divergent" prototype that will be modified with a concavity on the facial and proximal transition zones to obtain an abutment that will otherwise retain all the features of the control abutment. Engineers will measure the linear topographical changes (ΔL=Lc-Ld) of the transition zone, as well as the volumetric change (x) on the mid-facial aspect of the abutment induced by the formation of a submucosal concavity. The primary outcome of the study will be the apico-coronal change of the peri-implant mucosal zenith from prosthesis delivery to one year.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

61

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • University of Iowa College of Dentistry

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 18 years of age or greater
  • Subjects requiring replacement of a single-rooted tooth in the maxillary arch from first premolar to first premolar with an implant-supported restoration
  • Teeth adjacent (mesial and distal) to study site must consist of two stable, natural teeth without signs of periodontal bone loss (<2.0mm) and/or significant soft tissue loss
  • An opposing dentition with teeth, implants, or fixed prosthesis
  • Subjects must be willing to follow instructions related to the study procedures
  • Subjects must have read, understood, and signed the informed consent document

Exclusion Criteria:

Exclusion Criteria:

  • Insufficient interocclusal space for implant placement and/or restoration at study site
  • More than 2.0mm vertical bone loss at study site as measured from the mid-buccal crest of the bone on the adjacent teeth
  • Untreated rampant caries
  • Tobacco use free for ≤ 6 months
  • Liver or kidney disfunction/failure
  • Active severe infectious diseases that may affect normal healing and/or bone metabolism (e.g. AIDS)
  • Uncontrolled diabetes
  • Current alcohol or drug abuse
  • Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
  • History of relevant head/neck cancer and/or radiation of the head/neck
  • Subjects who currently use bisphosphonates or have a history of bisphosphonate use
  • Subjects with metabolic bone diseases such as osteoporosis or Paget's disease of bone
  • Known pregnancy or nursing mothers
  • Unable or unwilling to return for follow-up visits for a period of 1 year
  • Unlikely to be able to comply with study procedures according to investigators judgement

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Divergent Abutment
Divergent Transition Profile
Enhed: Divergent Transition Profile
An Atlantis abutment is delivered with a linear transition profile
Eksperimentel: Concave Abutment
Concave Transition Profile
Enhed: Concave Transition Profile
An Atlantis abutment is delivered with a concave transition profile.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Peri-Implant Mucosal Zenith Distance (in Millimeters) at the Concave/Divergent Abutment Sites
Tidsramme: Delivery, and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
Determine if there is a difference in soft tissue peri-implant zenith changes (in millimeters) for the concave/divergent abutment sites, specifically between at delivery and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery. This measurement is taken using a standardized stereotactic digital photography system that allows for increased measurement accuracy and precision, specifically with the Canfield Dental Camera, Canfield Imaging Systems.
Delivery, and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Submarginal Buccal-lingual Thickness (Millimeters) in the Peri-implant Transition Zone Relative to a Fixed Reference Point After Prosthesis Delivery
Tidsramme: Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
Determine if there is a difference in submarginal buccal-lingual soft tissue thickness in the peri-implant transition zone relative to a fixed reference point, specifically at baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery. This measurement is taken using a standardized stereotactic digital photography system that allows for increased measurement accuracy and precision, specifically with the Canfield Dental Camera, Canfield Imaging Systems.
Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
Keratinized Mucosa Width (Millimeters) at the Midfacial Aspect of the Implant Site.
Tidsramme: Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery
Determine if there is a difference in Keratinized Mucosa Width (millimeters) in the apico-coronal direction at the midfacial aspect of the implant site, specifically at baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery. This measurement is taken using a standardized stereotactic digital photography system that allows for increased measurement accuracy and precision, specifically with the Canfield Dental Camera, Canfield Imaging Systems.
Baseline and 1, 3, 6, and 12 months after Atlantis Abutment and Restoration Delivery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Christopher Barwacz

Efterforskere

  • Ledende efterforsker: Christopher A Barwacz, DDS, University of Iowa

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. december 2013

Primær færdiggørelse (Faktiske)

3. oktober 2018

Studieafslutning (Faktiske)

3. oktober 2018

Datoer for studieregistrering

Først indsendt

3. juni 2013

Først indsendt, der opfyldte QC-kriterier

3. juni 2013

Først opslået (Skøn)

6. juni 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juni 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2022

Sidst verificeret

1. maj 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 201302798

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Æstetik, Dental

Kliniske forsøg med Divergent Transition Profile

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Argentina

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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