Accuracy of Dental Implant Placement Using Two Different CBCT-derived Templates
15. august 2016 oppdatert av: 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Forventet)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Guangdong
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Guangzhou, Guangdong, Kina, 510000
- Rekruttering
- Guanghua school of stomatology, hospital of stomtology, Sun Yat-sen University
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Ta kontakt med:
- Zhuofan Chen, professor
- Telefonnummer: ＋8613902241868
- E-post: dentistczf@163.com
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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
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: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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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.
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Andre navn:
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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.
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Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Position changes between the planned and achieved implant position
Tidsramme: Change from preoperative to postoperative within 1 week
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Accuracy analysis.
The linear and angular deviations between the planned and achieved implant position are analyzed.
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Change from preoperative to postoperative within 1 week
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Implant and prosthesis survival
Tidsramme: Up to 18 months after baseline
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Implant and prosthesis survival will be determined at 6 months，12months and 18 months
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Up to 18 months after baseline
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Radiographic bone level
Tidsramme: Up to 18 months after baseline
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Radiographic bone level will be recorded at 6 months，12months and 18 months
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Up to 18 months after baseline
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The incidence of biological and mechanical complications
Tidsramme: Up to 18 months after baseline
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The incidence of biological and mechanical complications will be recorded at baseline, 6 months，12months and 18 months
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Up to 18 months after baseline
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Probing depth
Tidsramme: Up to 18 months after baseline
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Probing depth will be recorded at 6 months，12months and 18 months
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Up to 18 months after baseline
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Modified plaque index
Tidsramme: Up to 18 months after baseline
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Modified plaque index will be recorded at 6 months，12months and 18 months
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Up to 18 months after baseline
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Modified bleeding index
Tidsramme: Up to 18 months after baseline
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Modified bleeding index will be recorded at 6 months，12months and 18 months
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Up to 18 months after baseline
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Gingival index
Tidsramme: Up to 18 months after baseline
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Gingival index will be recorded at 6 months，12months and 18 months
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Up to 18 months after baseline
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Zhuofan Chen, professor, School of Stomatology, Hospital of Stomatology, Sun Yat-Sen 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
- Lopes A, Malo P, de Araujo Nobre M, Sanchez-Fernandez E. The NobelGuide(R) All-on-4(R) Treatment Concept for Rehabilitation of Edentulous Jaws: A Prospective Report on Medium- and Long-Term Outcomes. Clin Implant Dent Relat Res. 2015 Oct;17 Suppl 2:e406-16. doi: 10.1111/cid.12260. Epub 2014 Sep 5.
- Sun Y, Luebbers HT, Agbaje JO, Schepers S, Politis C, Van Slycke S, Vrielinck L. Accuracy of Dental Implant Placement Using CBCT-Derived Mucosa-Supported Stereolithographic Template. Clin Implant Dent Relat Res. 2015 Oct;17(5):862-70. doi: 10.1111/cid.12189. Epub 2013 Dec 16.
- Polizzi G, Cantoni T. Five-year follow-up of immediate fixed restorations of maxillary implants inserted in both fresh extraction and healed sites using the NobelGuide system. Clin Implant Dent Relat Res. 2015 Apr;17(2):221-33. doi: 10.1111/cid.12102. Epub 2013 Jun 23.
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
1. august 2016
Primær fullføring (Forventet)
1. november 2017
Studiet fullført (Forventet)
1. februar 2018
Datoer for studieregistrering
Først innsendt
4. mai 2016
Først innsendt som oppfylte QC-kriteriene
11. mai 2016
Først lagt ut (Anslag)
13. mai 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. august 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. august 2016
Sist bekreftet
1. mai 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ZhuofanChen
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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