Ti-Mesh-rammesammenligning til alveolær knogleforøgelse
Human alveolær knogleforstørrelse: Sammenligning 3-D CAD-CAM Ti-mesh-ramme med en konventionel Ti-Mesh-ramme fremstillet på tidspunktet for operationen
This research compares a chairside Titanium Mesh frame fabrication used during bone grafting procedures with the use of a computer-aided design/computer-assisted manufacture (CAD-CAM) Titanium Mesh frame. In addition, a novel method of measuring soft tissue thickness will be tested using an Optical scanner at various times during the sequence of surgeries.
The device used for shaping is a very thin, perforated titanium metal sheet with numerous small perforations (referred to as Micromesh). The construction of this device is usually accomplished chairside at the time of the surgery with custom cutting and shaping done using cues from the geometry of the surgical defect. An alternative approach will be tested where the mesh is pre-designed using digital information provided by a special xray and an optical scan device which takes a digital impression of the tooth and soft tissue surface. A digitally designed frame can then be printed using CAD-CAM software prior to surgery. This should reduce surgical time.
A randomized control trial of 30 patients needing 3-D bone augmentation will be conducted comparing chairside fabrication of Ti-MESH or TEST- CAD-CAM designed and preprinted Ti-MESH to investigate these objectives:
- Compare the operative times required for placement and removal of two different Ti-MESH frame fabrications
- Compare post-op wound healing -Ti MESH exposure rates, bone production (volume, contour, and quality) and soft tissue thickness changes during the 1-year study period.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
- BU Goldman School of Dental Medicine
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Partially edentulous
- Adult dental patients that require moderate 3-D bone augmentation for dental implant site improvement
Exclusion Criteria:
- Poor oral hygiene indices for microbial plaque (PI) and gingival inflammation (GI)
- Patients who have been on Chemotherapy or Radiation therapy within last 5 years.
- Patients under active treatment with following medications: Bisphosphonates, Gabapentin, Glucocorticoids, Methotrexate, or Estrogen supplements.
- Subjects under the direct supervision of the PI
- Smoking more than 10 cigarettes per day
- Uncontrolled diabetes or other metabolic disorders
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: CAD-CAM Ti-Mesh frame
Participants randomized into this arm will have their tooth loss treated with CAD-CAM designed and preprinted Ti-MESH during surgery. |
CAD-CAM technology which is the process of designing and manufacturing a custom-made dental device, or a patient-specific dental device from an industrialized product, with the aid of a computer.will be used to plan and preprint a 3-D Ti-Mesh frame prior to the surgery. |
|
Aktiv komparator: Conventional Ti-Mesh frame
Participants randomized into this arm will have their tooth loss treated with conventional chairside fabrication of Ti-MESH during surgery. |
A three-dimensional frame or cage of Ti-Mesh or Ti-reinforced d-polytetrafluoroethylene (PTFE) will be fashioned during the surgery to contain, shape and stabilize the bone graft materials (the internal scaffold). This 3-D frame will be custom fabricated from a perforated Ti Mesh sheet material at the time of surgery which takes considerable time and skill. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Bone contour accuracy
Tidsramme: 5 months post op
|
Bone contour accuracy will be derived by merger of the post op Cone beam computed tomography (CBCT) DICOM file with the CBCT-1/CEREC-1/Virtual Implant file produced at the planning stage. Accuracy of fit will be calculated for volume and linear measures (4 sides of each implant-MDBL) horizontal and vertical from the implant restorative platform. |
5 months post op
|
|
Total surgical time
Tidsramme: 2 hours
|
Total surgical time is defined as from incision time to completion of sutures and will be measured in minutes. |
2 hours
|
|
Surgical exposure time for recipient site
Tidsramme: 5 minutes
|
Surgical exposure time will be measured for recipient site in minutes |
5 minutes
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ti-Mesh exposure incidence
Tidsramme: 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
|
Number of exposures |
1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
|
|
Ti-Mesh exposure size
Tidsramme: 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
|
Ti-Mesh exposure size will be measured in millimeters |
1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
|
|
Ti-Mesh exposure location
Tidsramme: 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
|
Ti-Mesh exposure location will be documented within mucosa, gingiva, or at the incision line |
1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
|
|
Percentage of Vital bone
Tidsramme: 6 months
|
Percentage of vital bone will be measured in histologic sections of bone core taken at time of implant surgery. |
6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Serge Dibart, DMD, BU Goldman School of Dental Medicine, Oral Biology/Periodontics
- Studieleder: Albert M Price, DMD, BU Goldman School of Dental Medicine, Oral Biology/Periodontics
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H-43856
- AP 37 (Anden identifikator: Geistlich Pharma North America Inc)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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