Three-Dimensional Bone Augmentation of Severely Atrophied Posterior Mandibular Alveolar Ridges Using Customized-3D Zirconia Barriers Versus Pre-bent Titanium Mesh
7. juli 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
16
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Moataz Nasr
- Telefonnummer: 01000353417
- E-mail: Mo3taznasr@gmail.com
Studiesteder
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-
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Kafr Elsheikh, Egypten
- Rekruttering
- Kafr El-sheikh University
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Kontakt:
- Moataz Nasar, BDS
- Telefonnummer: 002 01000353417
- E-mail: mo3taznasr@gmail.com
-
Ledende efterforsker:
- Moataz Nasr, BDS
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-
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
- Voksen
Tager imod sunde frivillige
Ingen
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
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
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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.
|
up to 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 (Faktiske)
3. august 2024
Primær færdiggørelse (Anslået)
1. september 2026
Studieafslutning (Anslået)
1. september 2026
Datoer for studieregistrering
Først indsendt
7. juli 2026
Først indsendt, der opfyldte QC-kriterier
7. juli 2026
Først opslået (Faktiske)
13. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- KFSIRB200-205
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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