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

22. oktober 2020 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Forventet)

15

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: External hex implant
External hexagone implant connection
Enhet: 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 navn:
  • Radiological bone level
Eksperimentell: Internal hex implant
Internal implant connection
Enhet: 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 navn:
  • Radiological bone level

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Saint-Joseph University

Etterforskere

  • Hovedetterforsker: Nada Naaman, PhD, Saint-Joseph University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. april 2019

Primær fullføring (Faktiske)

30. november 2019

Studiet fullført (Forventet)

30. desember 2020

Datoer for studieregistrering

Først innsendt

3. april 2020

Først innsendt som oppfylte QC-kriteriene

8. april 2020

Først lagt ut (Faktiske)

13. april 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. oktober 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • FMD195

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

The outcome measurements and patients characteristics might be shared

IPD-delingstidsramme

1 year from date of publication

Tilgangskriterier for IPD-deling

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

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

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