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Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone

22. oktober 2020 opdateret af: Nada BOU ABBOUD NAAMAN, Saint-Joseph University

Clinical and Radiographic Evaluation of Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone: a 1-year Randomized Controlled Study

The aim of this prospective controlled clinical trial is to evaluate the clinical and radiographical outcomes of two implant surfaces inserted in a crest that has been horizontally augmented at least 6 months prior to the implant placement. The horizontal GBR should be done with a xenogenic graft mixed with autologous bone particles, and a collagen membrane stabilized using tacks or screws.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a prospective, randomized clinical and radiographical evaluation of bone remodeling around implants with two different surfaces placed in a previously augmented crest.

Patients requiring dental implants in previously horizontally augmented bone crest are recruited at the Department of Periodon¬tics, Faculty of dental medicine, Saint-Joseph University, Beirut, and will be treated with either T3 (contemporary hybrid collar), tapered, ex-hex, CP4 or Full Osseotite, tapered, ex-hex, CP4.

A total of 30 implants will be placed (15 per group). Random allocation of implant type per site will be done by the sealed envelope method.

The implants will be placed using a one-stage surgical approach. A final crown will be placed (screw-retained on multiunit abutment) between 3 and 4 months post-implant placement.

The patients will be followed-up at 6 months and 1 year. Only patients meeting inclusion/exclusion criteria and providing a dated and signed informed consent form will be enrolled in the study.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Libanon
      • Beirut, Libanon, 1104 2020
        • Saint-Joseph University

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

20 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patient age: between 20 and 65
  • No systematic contraindication for implant surgery
  • No more than 10 cigarettes/day
  • Previous horizontal bone augmentation 6 months prior to implant placement
  • Adequate oral hygiene i.e. Full mouth bleeding score (FMBS) <20% and Full mouth plaque score (FMPS) < 20%)

Exclusion Criteria:

  • Smokers more than 10 cigarettes/day
  • Pregnant/lactating women
  • Alcoholics/drug addicts
  • Uncontrolled diabetics, immunocompromised, blood hemostasis problems
  • Patients taking IV bisphosphonates or drugs affecting bone metabolism or mucosal healing
  • Patients not willing to sign the consent form
  • History of radiotherapy in the head and neck region in the last 5 years
  • Active periodontitis on the remaining teeth

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: External hex implant
External hexagone implant connection
Enhed: Implant insertion

In both groups, the implants will be placed using a two-stage surgical approach at the crestal level in previously horizontally augmented bony sites.

A final crown will be placed (screw-retained on multiunit abutment) between 3- and 4-months post-implant placement.

Random allocation of implant type per site will be done by the sealed envelope method.

Follow-up measurements will be done at 6 months and 1-year post-loading. The measurements are done by a blinded investigator. Before starting the study, the examiner will be trained in a calibration process.

Exam sheets are kept confidential and anonymous. Inclusion criteria are: patient aged 20 to 65, no systematic contraindication for implant surgery, smoking < 10 cigarettes, previous horizontal bone augmentation, FMBS <20% and FMPS < 20%. Exclusion criteria are: general contraindication for implant surgery, pregnant/lactating women, uncontrolled diabetics, patients not willing to sign the consent form, active periodontitis.

Andre navne:
  • Radiological bone level
Eksperimentel: Internal hex implant
Internal implant connection
Enhed: Implant insertion

In both groups, the implants will be placed using a two-stage surgical approach at the crestal level in previously horizontally augmented bony sites.

A final crown will be placed (screw-retained on multiunit abutment) between 3- and 4-months post-implant placement.

Random allocation of implant type per site will be done by the sealed envelope method.

Follow-up measurements will be done at 6 months and 1-year post-loading. The measurements are done by a blinded investigator. Before starting the study, the examiner will be trained in a calibration process.

Exam sheets are kept confidential and anonymous. Inclusion criteria are: patient aged 20 to 65, no systematic contraindication for implant surgery, smoking < 10 cigarettes, previous horizontal bone augmentation, FMBS <20% and FMPS < 20%. Exclusion criteria are: general contraindication for implant surgery, pregnant/lactating women, uncontrolled diabetics, patients not willing to sign the consent form, active periodontitis.

Andre navne:
  • Radiological bone level

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline of alveolar ridge thickness at 4 months
Tidsramme: During procedure and at 4 months
Peroperative surgical measurements of the alveolar ridge width at implant sites
During procedure and at 4 months
Change from baseline of radiographic bone level on CBCT at 1 year post-op
Tidsramme: During procedure and at 1 year
CBCT for buccal bone thickness measurements of the bone crest width at the implant site.
During procedure and at 1 year
Change from baseline of radiographic bone level assessment at 1 year post-op, on periapical x-ray
Tidsramme: During procedure, at 4 months, at 6 months and 1 year
Radiographic measurements on standardized periapical radiograph of the bone dimensions, for interproximal bone remodeling, from the shoulder of the implant (reference point), to the coronal bone to implant contact
During procedure, at 4 months, at 6 months and 1 year
Change from baseline of bone plate thickness at 4 months
Tidsramme: During procedure and at 4 months
Peroperative buccal and lingual residual bone thickness following implant insertion
During procedure and at 4 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Insertion torque
Tidsramme: During procedure
Manual torque insertion are registered at implant placement.
During procedure
Change of Clinical parameters from baseline to 1 year post-op
Tidsramme: During procedure, at 6 months and at 1 year
FMBS, FMPS,
During procedure, at 6 months and at 1 year
Change of FMBS parameters from baseline to 1 year post-op
Tidsramme: During procedure, at 6 months and at 1 year
Change in full mouth bleeding score
During procedure, at 6 months and at 1 year
Change of Keratinized tissue height from Baseline to 4 months
Tidsramme: During procedure and at 4 months
Measured using a 1.0-mm marked periodontal probe
During procedure and at 4 months
Histological analysis
Tidsramme: During procedure
Bone core taken with a 2mm trephine bur at the site of implant placement for non-demineralized histological assessment of regenerated bone quality
During procedure
Change of FMPS parameters from baseline to 1 year post-op
Tidsramme: During procedure, at 6 months and at 1 year
Change in full mouth plaque score
During procedure, at 6 months and at 1 year

Samarbejdspartnere og efterforskere

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

Sponsor

Saint-Joseph University

Efterforskere

  • Ledende efterforsker: Nada Naaman, PhD, Saint-Joseph University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

15. april 2019

Primær færdiggørelse (Faktiske)

30. november 2019

Studieafslutning (Forventet)

30. december 2020

Datoer for studieregistrering

Først indsendt

3. april 2020

Først indsendt, der opfyldte QC-kriterier

8. april 2020

Først opslået (Faktiske)

13. april 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • FMD195

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The outcome measurements and patients characteristics might be shared

IPD-delingstidsramme

1 year from date of publication

IPD-delingsadgangskriterier

Following a direct request, for meta-analysis or literature review report.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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 .

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Kliniske forsøg med Implant insertion

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