Histological and Histomorphometric Assessment With Inflammatory Profile Analysis of Bone Tissue After Horizontal Ridge Augmentation Using Customized Porous Zirconia Shell
Histological and Histomorphometric Assessment With Inflammatory Profile Analysis of Bone Tissue After Horizontal Ridge Augmentation of the Lower Posterior Mandible Using a Novel Customized Porous Zirconia Shell Technique: Clinical Case Study
The goal of this clinical study is to learn whether a custom-made porous zirconia shell can support good-quality new bone when widening the lower back jaw before dental implant placement. The study includes adults whose jawbone in this area is too narrow for implants (Seibert Class I defects).
The main question it aims to answer is: What is the quality of the new bone formed under a porous zirconia shell, and how much inflammation does the tissue show?
Participants will:
- Receive gum treatment and a CBCT scan before surgery
- Have bone augmentation surgery, in which a digitally designed porous zirconia shell is fixed over a mixture of their own bone and xenograft
- Return after 2 weeks for suture removal and a check of the wound
- Return after 6 months for a CBCT scan, removal of the shell, collection of a small bone sample (biopsy), and dental implant placement
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Horizontal bone loss in the posterior mandible often prevents dental implant placement. The Khoury technique uses thin autogenous cortical bone plates to rebuild the ridge, but harvesting these plates causes donor-site morbidity, is technically demanding, and is limited by available bone. Zirconia is biocompatible, mechanically strong and osteoconductive, and has shown low inflammatory response. However, it has not been studied as a shell replacing autogenous bone plates.
In this single-arm study, 10 adults with Seibert Class I defects in the posterior mandible will first receive non-surgical periodontal therapy. Compliance will be checked after 1 month. A zirconia shell with 1.5 mm pores will be digitally designed from each patient's CBCT scan, milled on a 5-axis machine, then cleaned and sterilized.
Under local anesthesia, buccal and lingual full-thickness flaps will be raised and the recipient bone decorticated. Autogenous bone chips will be harvested from the mandibular body with a bone chip maker and mixed 1:1 with xenograft. The shell will be fixed over the graft with 3-4 buccal screws. The flaps will be advanced and closed with a double-layer suture.
After 6 months, the shell will be removed, a core biopsy will be taken, and an implant will be placed. The biopsies will be fixed in 10% formalin and analyzed histologically, histomorphometrically and for tissue inflammatory response.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Mohammed Mahmoud Abed, BDS
- Telefonnummer: 00201118322238
- E-post: mohammed.mahmoud12@msa.edu.eg
Studer Kontakt Backup
- Navn: Ahmed Reda Abd Elrahman, PhD
- Telefonnummer: 00201206960001
- E-post: arrahman@msa.edu.eg
Studiesteder
-
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Giza Governorate
-
Giza, Giza Governorate, Egypt
- Rekruttering
- October University for Modern Sciences and Arts (MSA), Faculty of Dentistry
-
Ta kontakt med:
- Mohammed Mahmoud Abed, BDS
- Telefonnummer: 00201118322238
- E-post: mohammed.mahmoud12@msa.edu.eg
-
Ta kontakt med:
- Ahmed Reda Abd Elrahman, PhD
- Telefonnummer: 00201206960001
- E-post: arrahman@msa.edu.eg
-
Underetterforsker:
- Ahmed Reda Abd Elrahman, PhD
-
Hovedetterforsker:
- Mohammed Mahmoud Abed, BDS
-
Underetterforsker:
- Nada Abdelmonem Zazou, PhD
-
Underetterforsker:
- Mahmoud Ibrahim Nassar, PhD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age more than 21 years old
- Horizontal bone loss in the lower posterior area (Seibert Class I)
- Enough inter-arch space for placement of implant-supported prosthesis
- Motivated patient to have the treatment
- Good oral hygiene
Exclusion Criteria:
- Patients with systemic conditions that could interfere with the healing process
- Pregnant females
- Smokers
- Poor oral hygiene
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Customized Porous Zirconia Shell
Participants with horizontal bone defects in the posterior mandible receive ridge augmentation using a patient-specific porous zirconia shell fixed over a 1:1 mixture of autogenous bone and xenograft. After 6 months, the shell is removed, a bone biopsy is taken, and a dental implant is placed. |
A CAD/CAM-milled zirconia shell with 1.5 mm pores, designed from each patient's CBCT scan and fixed with 3-4 buccal screws over a 1:1 mix of autogenous bone chips and xenograft. It replaces the autogenous cortical plates used in the Khoury technique and is removed after 6 months. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of Newly Formed Bone Assessed by Descriptive Histological Analysis of the Core Biopsy
Tidsramme: 6 months after ridge augmentation (at shell removal and implant placement)
|
Histological analysis of the core bone biopsy harvested from the augmented site. Specimens will be fixed in a 10% formalin solution. Descriptive analysis of the cells and tissue structure of the augmented site within the biopsy (Dellavia et al., 2021). |
6 months after ridge augmentation (at shell removal and implant placement)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Newly Formed Bone (% of Total Biopsy Area)
Tidsramme: 6 months after augmentation
|
Histomorphometric measurement of the new bone area as a percentage of the total biopsy area. |
6 months after augmentation
|
|
Percentage of Residual Graft Material (% of Total Biopsy Area)
Tidsramme: 6 months after augmentation
|
Histomorphometric measurement of the remaining graft particle area as a percentage of the total biopsy area. |
6 months after augmentation
|
|
Percentage of Soft Tissue (% of Total Biopsy Area)
Tidsramme: 6 months after augmentation
|
Histomorphometric measurement of the non-mineralized connective tissue area as a percentage of the total biopsy area. |
6 months after augmentation
|
|
Inflammatory Cell Infiltration Score
Tidsramme: 6 months after augmentation
|
Semi-quantitative tissue response score from 0 (no inflammatory cells) to 4 (severe cellular infiltrate or tissue necrosis), based on the presence of lymphocytes, macrophages, foreign body giant cells, eosinophils and neutrophils. |
6 months after augmentation
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Nada Abdelmonem Zazou, PhD, October University for Modern Sciences and Arts (MSA)
- Studiestol: Ahmed Reda Abd Elrahman, PhD, October University for Modern Sciences and Arts (MSA)
- Studieleder: Mahmoud Ibrahim Nassar, PhD, October University for Modern Sciences and Arts (MSA)
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- REC-D 6206-5
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Individual participant data will not be shared to protect patient confidentiality, as stated in the approved protocol. Study results will be published in a peer-reviewed dental journal.
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