Effect of Changing Grafting Sequences During Sinus Lifting & Simultaneous Implant Placement in the Gained Bone Using Customized Surgical Guide
7. september 2026 opdateret af: ahmed atito said sayed, Cairo University
Effect of Changing Grafting Sequences During Sinus Lifting & Simultaneous Implant Placement in the Gained Bone Using Customized Surgical Guide: A Randomized Clinical Trial
The aim of this randomized clinical trial is to evaluate the effect of changing the sequence of bone grafting during maxillary sinus lifting and simultaneous dental implant placement.
The study compares a traditional sequence (sinus elevation, implant placement, then bone grafting) with a modified sequence (sinus elevation, bone grafting, then implant placement).
Both procedures utilize a customized surgical guide and are performed on patients with a vertical bone measurement of 5 mm or slightly more.
The primary goal is to assess bone density, along with secondary outcomes including vertical bone height gained, bone volume, and implant stability.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Maxillary sinus floor augmentation (MSFA) is a common procedure to restore vertical bone defects in the posterior maxilla to allow for oral rehabilitation using dental implants. However, traditional techniques can have demerits such as increased operative time, liability to infection, and increased complication rates. Despite advancements made to improve the surgical technique, several complications can yet arise which may compromise the success of the operation.
This study aims to enhance surgical sequences and compare the efficacy of sinus elevation, implant, and bone graft procedures using a customized surgical guide. The guide includes a lateral window for sinus elevation and a drill guiding hole for implant replacement. The study hypothesizes that the modified sequence (sinus elevation, bone graft, implant) is more accurate and provides better outcomes regarding bone density, stability, and height of the gained bone compared to the traditional sequence (sinus elevation, implant, bone graft).
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: Ahmed Atito Said Sayed, B. D. S
- Telefonnummer: +201026794490
- E-mail: ahmed.atito@dentistry.cu.edu.eg
Studiesteder
-
-
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Cairo, Egypten
- Rekruttering
- Faculty of Dentistry, Cairo University
-
Kontakt:
- Hesham El-Hawary, Professor
- Telefonnummer: +201144446373
- E-mail: hesham.elhawary@dentistry.cu.edu.eg
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Ledende efterforsker:
- Hesham El-Hawary, Phd
-
-
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
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Age more than 18 years.
- Both sexes.
- Patients eligible for maxillary sinus elevation, implant, and bone graft procedures.
- Adequate general health for dental interventions.
- Vertical bone measurement of 5 mm or slightly more.
Exclusion Criteria:
- Systemic conditions affecting implant success.
- Patients with vertical bone measurement less than 5 mm.
- Previous sinus surgery or dental implant failure.
- Medication that can impair or interfere with normal bone metabolism.
- History of head and neck radiotherapy.
- Pregnancy.
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Group A
Traditional sequence following standard protocols (sinus elevation, implant, bone graft) using a customized surgical guide.
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Sinus elevation is performed, followed by implant placement, and finally packing the opened lateral window with bone graft, all using a customized surgical guide.
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Eksperimentel: Group B
Modified sequence (sinus elevation, bone graft, and subsequent implant placement) using a customized surgical guide.
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Sinus elevation is performed, followed by packing the sinus with bone graft, and then implant osteotomies are drilled, all using a customized surgical guide.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Bone density
Tidsramme: 3 months and 6 months postoperative
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Assessed using Cone-beam computed tomography (CBCT) and measured in Hounsfield Units (HU)
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3 months and 6 months postoperative
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Vertical bone height gained
Tidsramme: 3 months and 6 months postoperative
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Evaluated using Cone-beam computed tomography (CBCT) and measured in millimeters (mm)
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3 months and 6 months postoperative
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Bone volume
Tidsramme: 3 months and 6 months postoperative
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Computed using Cone-beam computed tomography (CBCT) and measured in cubic centimeters (cm3)
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3 months and 6 months postoperative
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Implant stability
Tidsramme: Immediately following implant placement and after 6 months postoperatively
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Measured by an implant stability meter (OsstellISQ®) in ISQ VALUE
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Immediately following implant placement and after 6 months postoperatively
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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)
24. januar 2025
Primær færdiggørelse (Anslået)
30. december 2026
Studieafslutning (Anslået)
30. december 2026
Datoer for studieregistrering
Først indsendt
7. september 2026
Først indsendt, der opfyldte QC-kriterier
7. september 2026
Først opslået (Faktiske)
11. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 24125
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