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Long- Term Follow-up of Extraction Socket Management

24. januar 2018 opdateret af: Dr. France LAMBERT, University of Liege

Long- Term Follow-up of Extraction Socket Management : Clinical Outcomes and Hard Tissue Changes

Twenty-nine patients needing single tooth replacement in aesthetic area were treated by extraction and socket preservation with saddle connective tissue graft between September 2009 and February 2012. Computed Tomography scan were taken at baseline just after the surgery and 3 months later. Long- term evaluation of this particular socket management procedure was evaluated by recalling successfully seventeen of theses patients in June 2016. At this time, a clinical and radiographical consultation was done and Cone Beam CT was taken. Horizontal and vertical bone dimensional changes were then assessed thanks to 3D imaging analysis and esthetic and implants outcomes were evaluated.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

17

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

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients were recruited from the Department of Periodontology and Oral Surgery of the University of Liège, Belgium.

Beskrivelse

Inclusion Criteria:

  • Good general health (ASA 1, 2)
  • Controlled periodontitis
  • >18 years of age or signed consent by the parents
  • Smoking history of<10 cigarettes per day
  • Signed informed consent.

Exclusion Criteria:

  • Pregnancy or lactation
  • Concurrent participation in another trial
  • Bone disease or the use of medications that interfered with bone metabolism
  • History of head and neck radio- therapy
  • Presence of dehiscence or fenestration on bone wall of the socket.

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
Changes from Baseline Alveolar bone remodeling to 3 months and 6 year: horizontal measurements (based on CBCT, in mm)
Tidsramme: Baseline, 3 months, 6 years
The measurement were done by matching and superimposing CT scans using a three dimensional reconstruction software. Palatal horizontal measurements were calculated by subtracting the buccal horizontal measurements from the total horizontal measurements.
Baseline, 3 months, 6 years
Changes from Baseline Alveolar bone remodeling to 3 months and 6 year : vertical measurements (based on CBCT, in mm)
Tidsramme: Baseline, 3 months, 6 years
The measurement were done by matching and superimposing CT scans using a three dimensional reconstruction software. One vertical measurement was taken on the buccal side, in parallel to the vertical reference line at mid distance between the buccal wall and reference line.
Baseline, 3 months, 6 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Esthetic outcomes (PES questionnaire)
Tidsramme: Approximatively 6 years
At the cross- sectional long- term evaluation, to analyse the esthetic outcomes of the surgical procedure, the pink esthetic score (PES) was assessed (Fürhauser et al. 2005)
Approximatively 6 years
Esthetic outcomes (VAS questionnaire)
Tidsramme: Approximatively 6 years
A VAS questionnaire was given to the patients in order to collect their opinion about the esthetic results.
Approximatively 6 years
Implant survival rate (based on criteria of Buser et al., 1990)
Tidsramme: Approximatively 6 years
Success was defined according to the criteria of Buser et al., 1990 which are 1. absence of suppuration (recurring peri implant infection) 2. absence of persistent complaints like pain, foreign body sensation and/or dysesthesia 3. absence of continuous radioluncency area around the implant 4. absence of implant mobility.
Approximatively 6 years
Peri-implant bone levels (based on periapical radiography, in mm)
Tidsramme: Approximatively 6 years
The peri- implant bone levels were assessed on periapical radiography using the parallell technique: the distance between the implant shoulder and the first bone to implant contact (DIB) was measured at the mesial and distal aspects using the specific software Image J64 (National Institutes of Health, Bethesda, MD, USA).
Approximatively 6 years

Samarbejdspartnere og efterforskere

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

Sponsor

University of Liege

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)

1. juni 2016

Primær færdiggørelse (Faktiske)

1. juli 2016

Studieafslutning (Faktiske)

1. juli 2017

Datoer for studieregistrering

Først indsendt

26. juli 2017

Først indsendt, der opfyldte QC-kriterier

24. januar 2018

Først opslået (Faktiske)

25. januar 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. januar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. januar 2018

Sidst verificeret

1. januar 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H2016-2 ExMA5

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Tandtab

Kliniske forsøg med Socket preservation

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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