Å sammenligne de to implantatplasseringsprotokollene for å evaluere plasseringsnøyaktighet og postoperativ helbredelse av implantatet
Vurdering av to implantatplasseringsprotokoller for å evaluere plasseringsnøyaktighet og postoperativ helbredelse
The goal of this study is to evaluate two commonly utilized surgical guide protocols to determine dental implant placement accuracy compared to pre-operative computerized planning, post-operative healing and bone levels to 12-months post-placement, and patient assessed post-operative discomfort and healing using a visual acuity scale (VAS).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This proposed study would allow us to assess the use of two intraoperative surgical guide protocols in common use in dental practice (matrix-based pilot drill guided and fully digital guided) for implant placement surgical procedure.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Sarah Startley, DMD
- Telefonnummer: 205-975-8711
- E-post: ss1971@uab.edu
Studer Kontakt Backup
- Navn: Maria Geisinger, DDS, MS
- Telefonnummer: 205-934-4984
- E-post: miagdds@uab.edu
Studiesteder
-
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Alabama
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Birmingham, Alabama, Forente stater, 35294-0007
- University of Alabama at Birmingham
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Ta kontakt med:
- Sarah Startley, DMD
- Telefonnummer: 205-975-8711
- E-post: ss1971@uab.edu
-
Ta kontakt med:
- Maria Geisinger, DDS, MS
- Telefonnummer: 205-934-4984
- E-post: miagdds@uab.edu
-
Hovedetterforsker:
- Maria L Geisinger, DDS, MS
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- English speaking
- At least 18 years old
- Must be a patient of the UAB Dental School
- Able to read and understand informed consent document
- Patients presenting with a single edentulous site planned for dental implant placement
- Presence of periodontally healthy, non-carious neighboring teeth and/or healthy restored dental implants on either side of edentulous site planned for dental implant placement.
- No anticipated need for surgical and/or endodontic care at teeth adjacent to the proposed surgical site during the study period.
Exclusion Criteria:
- Non-English speaking
- Less than 18 years old
- Smokers/tobacco users (>10 cigarettes/day)
- Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
- Absence of adjacent teeth/implants on either side of the tooth to be extracted and/or edentulous sites where 2 or more adjacent implants are planned.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Pilot Drill Guide (PDG)
Matrix-based pilot drill guides fabricated using casts derived from digital wax ups of the proposed final restoration based upon initial implant planning and will be placed using the standard manufacturer's protocol. |
Matrix-based pilot drill guides fabricated using casts derived from digital wax ups of the proposed final restoration based upon initial implant planning and will be placed using the standard manufacturer's protocol. |
|
Eksperimentell: Fully Guided (FG
3-D printed guides fabricated based upon digital wax ups and will be placed using the standard manufacturer's protocol and guided implant placement kits |
3-D printed guides fabricated based upon digital wax ups and will be placed using the standard manufacturer's protocol and guided implant placement kits. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Implant placement deviation from computerized planning
Tidsramme: 12 months
|
Implant placement deviation from computerized planning at 12-month post-placement using CBCT overlay measurement techniques. |
12 months
|
|
Radiographic marginal bone loss
Tidsramme: From baseline to 12 months
|
Radiographic marginal bone loss as measured using digital measurement tools and calibrated parallel two-dimensional radiographic images from baseline dental implant placement to 12-months post-implant placement |
From baseline to 12 months
|
|
Patient centered outcomes using the Visual Analog Scale (VAS
Tidsramme: 4 weeks
|
Patient centered outcomes including pain, bleeding, swelling, change in daily activities at 7, 14, and 30 days postoperatively, using the Visual Analog Scale (VAS) This measurement ranges from 0-10 (0 being better and 10 being worse). |
4 weeks
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Maria L Geisinger, DDS, MS, University of Alabama at Birmingham
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- IRB-300016397
- UAB Periodontology (Annen identifikator: University of Alabama at Birmingham)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Data from this study will not be shared with other researchers outside of our research team.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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