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Accuracy of Dental Implant Placement Using Two Different CBCT-derived Templates

15. august 2016 opdateret af: Zhuofan Chen, Sun Yat-sen University

Accuracy of Dental Implant Placement Using Two Different CBCT-derived Templates: a Randomized Controlled Clinical Trial

The main purpose of the present study is to evaluate the dental implant placement using two different CBCT-derived templates and to study the related factors that affect accuracy so as to support the further clinical application of the technique. Thirty patients with partial edentulous denture are recruited. They are randomized to two groups. A radiographic guide is prepared before CT/CBCT scan. The CT/CBCT scan DICOM files are loaded in a planning program and converted into 3D computer images. A surgical template is fabricated through this virtual planning. After 6 weeks, if the implants are judged stable, the patient has the option of replacing the fixed prosthesis. Patients are recalled for oral hygiene maintenance and prosthetic controls every 6 months for the entire duration of the study.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510000
        • Rekruttering
        • Guanghua school of stomatology, hospital of stomtology, Sun Yat-sen University
        • Kontakt:

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

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Partial edentulism
  • Missing more than three teeth in succession
  • Presence of adjacent teeth
  • Systemically healthy
  • Good maxillomandibular relation
  • Maximal mouth opening>5 mm

Exclusion Criteria:

  • Poor oral hygiene
  • Severe parafunctional habits, for example, bruxing and clenching
  • Presence of clinically active periodontal disease as expressed by probing pocket depths≥4 mm in combination with bleeding on probing
  • Maxillary sinus involvement
  • Conditions that might lead to a possibly lowered regenerative capacity of the bone, for example, osteoporosis and Paget's disease
  • Pregnant or expecting to be pregnant
  • History of drug and alcohol abuse
  • History of systemic diseases that would contraindicate oral surgical treatment, for example, uncontrolled diabetes (defined as HBA1c level >7%)
  • Radiotherapy in the head and neck area
  • On certain medications like bisphosphonates or steroids currently or within the past three months
  • Unwillingness to return for the follow-up examination
  • Smokers (more than20 cigarettes per day). Subjects smoking <20 cigarettes per day were requested to stop smoking before and after surgery

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: GuideMia surgical template
A radiographic guide is prepared before CT/CBCT scan. The CT/CBCT scan DICOM files are loaded in GuideMia program and converted into 3D computer images. A surgical template is fabricated through this virtual planning.
Enhed: Surgical Template
Andre navne:
  • styring
  • GuideMia
Aktiv komparator: Control surgical template
A radiographic guide is prepared before CT/CBCT scan. The CT/CBCT scan DICOM files are loaded in control program and converted into 3D computer images. A surgical template is fabricated through this virtual planning.
Enhed: Surgical Template
Andre navne:
  • styring
  • GuideMia

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Position changes between the planned and achieved implant position
Tidsramme: Change from preoperative to postoperative within 1 week
Accuracy analysis. The linear and angular deviations between the planned and achieved implant position are analyzed.
Change from preoperative to postoperative within 1 week

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Implant and prosthesis survival
Tidsramme: Up to 18 months after baseline
Implant and prosthesis survival will be determined at 6 months，12months and 18 months
Up to 18 months after baseline
Radiographic bone level
Tidsramme: Up to 18 months after baseline
Radiographic bone level will be recorded at 6 months，12months and 18 months
Up to 18 months after baseline
The incidence of biological and mechanical complications
Tidsramme: Up to 18 months after baseline
The incidence of biological and mechanical complications will be recorded at baseline, 6 months，12months and 18 months
Up to 18 months after baseline
Probing depth
Tidsramme: Up to 18 months after baseline
Probing depth will be recorded at 6 months，12months and 18 months
Up to 18 months after baseline
Modified plaque index
Tidsramme: Up to 18 months after baseline
Modified plaque index will be recorded at 6 months，12months and 18 months
Up to 18 months after baseline
Modified bleeding index
Tidsramme: Up to 18 months after baseline
Modified bleeding index will be recorded at 6 months，12months and 18 months
Up to 18 months after baseline
Gingival index
Tidsramme: Up to 18 months after baseline
Gingival index will be recorded at 6 months，12months and 18 months
Up to 18 months after baseline

Samarbejdspartnere og efterforskere

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

Sponsor

Sun Yat-sen University

Efterforskere

  • Ledende efterforsker: Zhuofan Chen, professor, School of Stomatology, Hospital of Stomatology, Sun Yat-Sen 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

1. august 2016

Primær færdiggørelse (Forventet)

1. november 2017

Studieafslutning (Forventet)

1. februar 2018

Datoer for studieregistrering

Først indsendt

4. maj 2016

Først indsendt, der opfyldte QC-kriterier

11. maj 2016

Først opslået (Skøn)

13. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. august 2016

Sidst verificeret

1. maj 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ZhuofanChen

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 Surgical Template

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Betingelser

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