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Aesthetic Evaluation of Two Piece 3mm Implants for Single Tooth Replacement of Maxillary Laterals and Mandibular Incisors

2. maj 2011 opdateret af: Dr.Suzanne Caudry Implant Dentistry and Periodontics
Aesthetic evaluation of two piece 3mm implants for single tooth replacement of maxillary laterals and mandibular incisors

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

PURPOSE OF THE STUDY:

The purpose of this research study is to examine the aesthetics (the appearance of the implanted tooth and gums) as well as the soft tissue loss over a three-year period. This study involves replacing a missing small front tooth with a dental implant, abutment, and crown. A titanium dental implant acts as the replacement for a tooth root. An abutment is made of titanium which is either gold or silver in color and cannot be seen; but may affect the way the gum looks. An abutment is the component that attaches the crown to the implant post. A crown (which acts as the tooth replacement) is made of metal and/or porcelain and attaches over the abutment.

The dental implant and the abutments used in this study have been approved by Health Canada and the U.S. Food and Drug Administration (FDA) for the use of replacing the small teeth in the front of the mouth.

The abutment is made in two colors (either gold or silver) and you cannot choose. For each subject this is decided by chance. You will have an equal chance of getting a gold or silver-colored attachment. You will know which color the abutment will be once you have consented to be in the study and registered. You will know the color of the abutment before the implant is placed. The abutment is covered by the crown.

You will be in this study for about three years. There will be approximately 60 subjects who will participate in this study in different centres, in Canada and the USA.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

60

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5R 3K4
        • Dr. Suzanne Caudry PhD DDS MSc Perio Implant Dentistry and Periodontics

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Subjects for this study will be recruited from the practices of the six study centers (Dr. Caudry + 5 centers from the North American PEERS group) within a period of eighteen months from commencement of the study. A total of sixty subjects (ten per center) of any gender and race aged 18 and older will be accepted provided they meet the inclusion and exclusion criteria (see page 6). Dental implants for permanent tooth replacement are not indicated for use in those under the age of 18. Vulnerable subjects will not be included.

Beskrivelse

Inclusion Criteria:

  • Capacity to provide written informed consent to participate in the study.
  • 18 years or older

Site requirements:

Missing one or both maxillary lateral incisors (if missing both, then both sites must be used in the study) or Single missing mandibular incisor or Two missing mandibular incisors, not adjacent to one another (both sites must be used in the study) Aside from the missing teeth specified above, all other teeth in the sextant must be present.

A minimum of premolar occlusion is required. A minimum mesio-distal and buccal-lingual distance of 5mm is required

Exclusion Criteria:

  • Rampant caries or unstable periodontal disease of the remaining dentition.
  • Any systemic or local disease or condition that may compromise post-operative healing.
  • Long-term use of systemic corticosteroids or other medications that may compromise post-operative healing.
  • Present alcohol and/or drug abuse.
  • Unable or unwilling to return for follow-up exams over a 3 year period.
  • Pregnancy or lactation at time of enrollment.
  • Smokers will be excluded from the subject pool.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recession
Tidsramme: every 12 months for 3 years
The Astra Tech 3.0 mm 2 piece implant can be placed and restored in a 5 mm or greater bone space for a mandibular incisor or maxillary lateral incisor site (minimum 5 mm mesio-distal [side to side] bone width and 5mm bucco-lingual [front to back] bone width) without exhibiting recession of the soft tissue (gingival margin or the interproximal papillae).
every 12 months for 3 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Esthetic parameter Scores
Tidsramme: every 12 months up to three years
Esthetic parameter scores will be higher when the Atlantis Gold Hue titanium abutment is used in comparison to the Atlantis titanium abutment.
every 12 months up to three years

Samarbejdspartnere og efterforskere

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

Sponsor

Dr.Suzanne Caudry Implant Dentistry and Periodontics

Efterforskere

  • Ledende efterforsker: Dr. Suzanne D Caudry, DDS PhD, Implant Dentistry and Periodontics

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

1. maj 2011

Primær færdiggørelse (Forventet)

1. marts 2015

Studieafslutning (Forventet)

1. maj 2015

Datoer for studieregistrering

Først indsendt

29. april 2011

Først indsendt, der opfyldte QC-kriterier

2. maj 2011

Først opslået (Skøn)

3. maj 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. maj 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. maj 2011

Sidst verificeret

1. april 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • WIRB® Protocol #20101573

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 Recession

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bangladesh

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner