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Bone Dimensional Changes at Different Implant-to-abutment Connections: a 1-year Clinical and Radiological Study

1. september 2016 opdateret af: Proed, Torino, Italy

Aim of the present study will be to evaluate if the platform switching and the flat abutment can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft tissues will also be provided.

80 consecutively inserted dental implants will be included in this study. Maxillary and mandibular implants will be considered, both in frontal and posterior area. After 6 to 12 weeks, the definitive prosthetic abutment will be screwed and the temporary crown cemented. After 2 more months, the definitive porcelain crown will be delivered. The final outcomes will be collected after 1 year from implant insertion.

Data will refer to the following timing:

T0= implant installation T1= temporary crown cementation T2= definitive crown cementation T3= 1 year follow-up The 80 implants will be randomly divided into 4 groups of 20 implants each, with different implant/abutment design.

Group 1: Tapered T3 Standard Collar implants + GingiHue abutments Group 2: Tapered T3 Standard Collar implants + Tissuemax IL abutments Group 3: Tapered T3 Prevail implants + GingiHue abutments Group 4: Tapered T3 Prevail implants + Tissuemax IL abutments On x-rays, the mesial and distal Marginal Bone Level will be measured and compared among and between the groups at the 4 different timing.

Pocket Depth and Bleeding on probing (mesial, buccal, distal and lingual) will be measured at T0, T1, T2 and T3. Data will be statistically analyzed.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

BACKGROUND:

Platform switching is intended to preserve marginal bone around implants. Studies have shown that implants using an integrated platform switching demonstrate crestal bone loss as low as 0.37mm, and 30 to 50% reduction in crestal bone loss when compared to non-platform switching implants. Recently, a new design titanium abutment (Tissuemax IL) has been proposed to modulate the soft tissue integration around implant supported crowns. A new implant with a hybrid surface (T3) has been recently launched by Biomet 3i, providing both integrated platform switching (Prevail) or non platform switching (Standard Collar).

Aim of the present study will be to evaluate if the platform switching and the Tissuemax abutment can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft tissues will also be provided.

MATERIALS & METHODS:

80 consecutively inserted dental implants will be included in this study. Maxillary and mandibular implants will be considered, both in frontal and posterior area. Implants should be inserted in preexisting adequate bone volume, without the need for any bone augmentation technique. Implants will be inserted with a transmucosal healing (single-stage surgical procedure) with immediate connection of the healing abutment. After 6 to 12 weeks, the definitive prosthetic abutment will be screwed and the temporary crown cemented. After 2 more months, the definitive porcelain crown will be delivered. The final outcomes will be collected after 1 year from implant insertion.

Data will refer to the following timing:

T0= implant installation T1= temporary crown cementation T2= definitive crown cementation T3= 1 year follow-up The 80 implants will be randomly divided into 4 groups of 20 implants each, with different implant/abutment design.

Group 1: Tapered T3 Standard Collar implants + GingiHue abutments Group 2: Tapered T3 Standard Collar implants + Tissuemax IL abutments Group 3: Tapered T3 Prevail implants + GingiHue abutments Group 4: Tapered T3 Prevail implants + Tissuemax IL abutments The division into the 4 group will be randomized. Standardized intraoral radiograms will be done at T0, T1, T2 and T3. On x-rays, the mesial and distal Marginal Bone Level will be measured and compared among and between the groups at the 4 different timing.

Pocket Depth and Bleeding on probing (mesial, buccal, distal and lingual) will be measured at T0, T1, T2 and T3. Data will be statistically analyzed.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

80

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

    • TO
      • Torino, TO, Italien, 10129
        • PROED, Institute for Professional Education in 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:

  • Healthy adult patients with partial edentulism

Exclusion Criteria:

  • Current pregnant patients
  • History of malignancy
  • History of radiotherapy or chemiotherapy in the last 5 years
  • Long term steroidal or antibiotic therapy

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: standard platform , standard abutment
implant insertion and abutment connection Osseointegrated implants with regular collar connected to standard designed prosthetic abutments
After implant insertion (standard platform or switching platform) the titanium abutment (standard or flat) will be connected
Aktiv komparator: standard platform, flat abutment
implant insertion and abutment connection Osseointegrated implants with regular collar connected to flat designed prosthetic abutments
After implant insertion (standard platform or switching platform) the titanium abutment (standard or flat) will be connected
Aktiv komparator: switching platform, standard abutment
implant insertion and abutment connection Osseointegrated implants with switched platform collar connected to standard designed prosthetic abutments
After implant insertion (standard platform or switching platform) the titanium abutment (standard or flat) will be connected
Aktiv komparator: switching platform, flat abutment
implant insertion and abutment connection Osseointegrated implants with switched platform collar connected to flat designed prosthetic abutments
After implant insertion (standard platform or switching platform) the titanium abutment (standard or flat) will be connected

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Marginal Bone Level
Tidsramme: 1 year after implant installation
On standardized intraoral radiograms, mesial and distal marginal bone level at implant surface will be measured
1 year after implant installation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Probing Pocket Depth
Tidsramme: 1 year after implant installation
Probing depth measured mesially, buccaly, distally and lingually at implant site
1 year after implant installation
Bleeding on Probing
Tidsramme: 1 year after implant installation
Bleeding on Probing measured mesially, buccaly, distally and lingually at implant site
1 year after implant installation

Samarbejdspartnere og efterforskere

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

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. marts 2013

Primær færdiggørelse (Faktiske)

1. marts 2014

Studieafslutning (Faktiske)

1. september 2015

Datoer for studieregistrering

Først indsendt

7. marts 2013

Først indsendt, der opfyldte QC-kriterier

7. marts 2013

Først opslået (Skøn)

8. marts 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. september 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. september 2016

Sidst verificeret

1. september 2016

Mere information

Begreber relateret til denne undersøgelse

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 Kæbe, Edentuous, Delvis

Kliniske forsøg med implant insertion and abutment connection

Abonner