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- Klinische proef NCT07589426
Horizontal Ridge Augmentation in Maxillary Esthetic Zone Using Bovine Bone Graft Versus Extended Sticky Bone With Simultaneous Implant Placement
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Patient selection This study will involve sixteen implants inserted in patients with missing upper tooth / teeth in the esthetic zone accompanied by horizontal alveolar ridge resorption, seeking future tooth replacement. The patients will be selected from the Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University
Inclusion Criteria:
- Patient aged 18-45 years.
- Cooperative patient with high motivation and acceptable oral hygiene.
- Maxillary narrow ridge in the esthetic zone that needed horizontal bone augmentation. (Class I Siebert classification). (22)
- No deep undercut at the ridge in the buccal aspect.
- The presence of enough keratinized gingiva(≥3mm).(23)
- Sufficient inter-arch space to accommodate the future prosthesis. (24)
- Patients able to comply with the required recall visits.
Exclusion criteria:
- Local and / or systemic conditions that contraindicate the placement of dental implant or surgery
- Smokers
- Pregnancy.
- Parafunctional habits, including bruxism and clenching.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Al Mansurah, Egypte
- Mansoura University
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Al Mansurah, Egypte
- Amira Attia
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Patient aged 18-45 years, Cooperative patient with high motivation and acceptable oral hygiene, maxillary narrow ridge in the esthetic zone that needed horizontal bone augmentation. (Class I Siebert classification) (24),No deep undercut at the ridge in the buccal aspect, The presence of enough keratinized gingiva(≥3mm).(25), sufficient inter-arch space to accommodate the future prosthesis. (26) , and Patients able to comply with the required recall visits.
Exclusion Criteria:
- Local and / or systemic conditions that contraindicate the placement of dental implant or surgery, smokers, pregnancy and parafunctional habits, including bruxism and clenching.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Eight dental implants were inserted simultaneously with horizontal ridge augmentation using Medpark
For group I, Medpark bone graft was prepared by hydration with sterile saline, gentle mixing, and allowed to partially set before application to the defect site.
For group II, extended sticky bone (ESB) was prepared by centrifugation of autologous blood followed by preparation of ALB-PRF and mixing with bone particulates (50:50 allograft: xenograft) to obtain the final graft materia
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The oral cavity was prepared using 0.12% chlorhexidine mouth rinse for one minute. Local anesthesia was administered using articaine 4% with 1:100,000 epinephrine. A full-thickness mucoperiosteal flap was reflected using a crestal horizontal incision with vertical releasing incisions to expose the surgical site. Osteotomy preparation was performed using a pilot drill to the planned depth at 800-850 rpm under copious sterile saline irrigation, followed by sequential drilling according to the manufacturer's protocol until the final implant size was achieved. The sterile implant was then inserted using a ratchet wrench. Implant stability was immediately assessed using resonance frequency analysis (Osstell device), and cover screws were subsequently placed. For group I, Medpark bone graft was prepared by hydration with sterile saline, gentle mixing, and allowed to partially set before application to the defect site. For group II, extended sticky bone (ESB) was prepared b The oral cavity was prepared using 0.12% chlorhexidine mouth rinse for one minute. Local anesthesia was administered using articaine 4% with 1:100,000 epinephrine. A full-thickness mucoperiosteal flap was reflected using a crestal horizontal incision with vertical releasing incisions to expose the surgical site. Osteotomy preparation was performed using a pilot drill to the planned depth at 800-850 rpm under copious sterile saline irrigation, followed by sequential drilling according to the manufacturer's protocol until the final implant size was achieved. The sterile implant was then inserted using a ratchet wrench. (Fig.1B & Fig.2B) Implant stability was immediately assessed using resonance frequency analysis (Osstell device), and cover screws were subsequently placed. For group I, Medpark bone graft was prepared by hydration with sterile saline, gentle mixing, and allowed to partially set before application to the defect site. For group II, extended sticky bone (ESB) was prepared b |
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Experimenteel: Eight dental implants were inserted simultaneously with horizontal ridge augmentation using extended
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The oral cavity was prepared using 0.12% chlorhexidine mouth rinse for one minute. Local anesthesia was administered using articaine 4% with 1:100,000 epinephrine. A full-thickness mucoperiosteal flap was reflected using a crestal horizontal incision with vertical releasing incisions to expose the surgical site. Osteotomy preparation was performed using a pilot drill to the planned depth at 800-850 rpm under copious sterile saline irrigation, followed by sequential drilling according to the manufacturer's protocol until the final implant size was achieved. The sterile implant was then inserted using a ratchet wrench. Implant stability was immediately assessed using resonance frequency analysis (Osstell device), and cover screws were subsequently placed. For group I, Medpark bone graft was prepared by hydration with sterile saline, gentle mixing, and allowed to partially set before application to the defect site. For group II, extended sticky bone (ESB) was prepared b The oral cavity was prepared using 0.12% chlorhexidine mouth rinse for one minute. Local anesthesia was administered using articaine 4% with 1:100,000 epinephrine. A full-thickness mucoperiosteal flap was reflected using a crestal horizontal incision with vertical releasing incisions to expose the surgical site. Osteotomy preparation was performed using a pilot drill to the planned depth at 800-850 rpm under copious sterile saline irrigation, followed by sequential drilling according to the manufacturer's protocol until the final implant size was achieved. The sterile implant was then inserted using a ratchet wrench. (Fig.1B & Fig.2B) Implant stability was immediately assessed using resonance frequency analysis (Osstell device), and cover screws were subsequently placed. For group I, Medpark bone graft was prepared by hydration with sterile saline, gentle mixing, and allowed to partially set before application to the defect site. For group II, extended sticky bone (ESB) was prepared b |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Implant Stability Quotient (ISQ) Values Assessed by Resonance Frequency Analysis
Tijdsspanne: Baseline and 6 months after implant placement
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Implant stability was assessed using resonance frequency analysis (RFA) with the Osstell device and expressed as Implant Stability Quotient (ISQ) values. ISQ scores range from 1 to 100, with higher scores indicating greater implant stability and osseointegration. High stability: ISQ > 70 Medium stability: ISQ 60-69 Low stability: ISQ < 60 Measurements were recorded immediately after implant placement and at the 6-month follow-up. |
Baseline and 6 months after implant placement
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Ms.25.04.21
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