Three-Dimensional Bone Augmentation of Severely Atrophied Posterior Mandibular Alveolar Ridges Using Customized-3D Zirconia Barriers Versus Pre-bent Titanium Mesh
7. juli 2026 oppdatert av: Hams Hamed Abdelrahman
Assessment of Three-Dimensional Bone Augmentation of Severely Atrophied Posterior Mandibular Alveolar Ridges Using Customized-3D Zirconia Barriers Versus Pre-bent Titanium Mesh: A Randomized Controlled Clinical Trial
Zirconia can be considered as an alternative and innovative material suitable for GBR because it has high biocompatibility, together with a scarce tissue integration.
Zirconia barriers could be a predictable and alternative barrier material for GBR in terms of (i) biocompatibility, (ii) ease of use and removal, (iii) exposure management, (iv) bone regeneration outcomes.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
16
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Moataz Nasr
- Telefonnummer: 01000353417
- E-post: Mo3taznasr@gmail.com
Studiesteder
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-
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Kafr Elsheikh, Egypt
- Rekruttering
- Kafr El-sheikh University
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Ta kontakt med:
- Moataz Nasar, BDS
- Telefonnummer: 002 01000353417
- E-post: mo3taznasr@gmail.com
-
Hovedetterforsker:
- Moataz Nasr, BDS
-
-
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
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Patients are systemically medically free according to the American Society of Anesthesiologists (ASA) considered as ASA I.
- Ability to maintain good oral hygiene as evidenced in recall visits.
- patients who had a partial or completely edentulous alveolar ridge with apparent 3D defect following teeth loss.
- All patients were free from any local or general disease that may interfere with bone healing and had no history of previous grafting procedure at the designated edentulous ridge.
- The ridge had to exhibit severe vertical and horizontal (3D) alveolar ridge deficiency with alveolar ridge height less than 7 mm from the alveolar crest to the inferior alveolar canal and width less than 5 mm which was firstly measured by CBCT, or a clinically apparent increase in inter-arch space relative to the adjacent natural teeth.
- Pre-operative clinical assessment of soft tissue coverage was done to cover the graft and its membrane, in addition to assessment of occlusion and inter-arch distance should allow for the graft, membrane, implan and the future prosthesis.
Exclusion Criteria:
- Smoker (> 25 cigarettes/ day).
- Patients undergoing radiotherapy or chemotherapy
- Patients having infection or local lesions in the area of surgery.
- Patients with diabetes mellitus or bone diseases which may compromise the results.
- Patient with poor oral hygiene or active periodontal disease.
- Patient with limited mouth opening.
- Participation in other clinical trials
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: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Zirconia
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It includes eight patients seeking for placement of customized Zirconia barrier after GBR in 1st stage surgery then implants placement in 2nd stage surgery in the alveolar ridges.
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Eksperimentell: Titanium
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It includes eight patients seeking for placement prebent titanium mesh as barriers after GBR in 1st stage surgery then implants placement in 2nd stage surgery in the alveolar ridges.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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change in vertical height of ridge
Tidsramme: up to 6 months
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Cone Beam Computed Tomography (CBCT) was done immediately (1 week) and after six months to evaluate the changes in vertical, horizontal and volumetric measurements of the ridge.
OnDemand3D™ software was used to evaluate vertical and horizontal height.
Measurements were taken as follows: From the toolbar, the ruler was selected from the measurement section.
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up to 6 months
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change in horizontal width of ridge
Tidsramme: up to 6 months
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Cone Beam Computed Tomography (CBCT) will be done immediately (1 week) and after six months OnDemand3D™ software will be used.
Measurements were taken as follows: From the toolbar, the ruler was selected from the measurement section.
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up to 6 months
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change in volume of ridge
Tidsramme: up to 6 months
|
Cone Beam Computed Tomography (CBCT) will be done immediately (1 week) and after six months OnDemand3D™ software will be used.
Measurements were taken as follows: From the toolbar, the ruler was selected from the measurement section.
|
up to 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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symptoms of infection
Tidsramme: up to one month
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Any symptoms of infection including swelling, redness, hotness, pus discharge, and pain will be recorded
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up to one month
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manifestations of wound healing disturbance
Tidsramme: up to one month
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observation for any manifestations of wound healing disturbance, as wound dehiscence and hardware exposure will be recorded
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up to one month
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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)
3. august 2024
Primær fullføring (Antatt)
1. september 2026
Studiet fullført (Antatt)
1. september 2026
Datoer for studieregistrering
Først innsendt
7. juli 2026
Først innsendt som oppfylte QC-kriteriene
7. juli 2026
Først lagt ut (Faktiske)
13. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- KFSIRB200-205
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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