Titanium Versus Nano-Carbon CAD/CAM Frameworks for All-on-4 Implant Supported Hybrid Prosthesis.
16. september 2026 opdateret af: Ahmed Farouk Abdelwahed Saleh, Mansoura University
Titanium Versus Nano-Carbon CAD/CAM Frameworks for All-on-4 Implant Supported Hybrid Prosthesis. A Study of Peri-implant Tissue Changes and Prosthetic Complications
This clinical study compares two CAD/CAM framework materials, titanium and nano-carbon fiber-reinforced composite, used in mandibular All-on-4 implant-supported hybrid prostheses.
Ten completely edentulous patients are randomly allocated into two equal groups.
The study evaluates peri-implant soft tissue health, changes in marginal bone levels,and prosthetic complications over an 12-month follow-up period.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Completely edentulous patients receive four mandibular implants according to the All-on-4 concept, with two anterior axial implants and two posterior tilted implants placed anterior to the mental foramina.
Patients are randomly allocated to receive either a CAD/CAM-milled titanium framework or a nano-carbon fiber-reinforced framework.
Clinical follow-up includes assessment of modified plaque index, modified gingival index, probing depth, and bleeding index.
Marginal bone level changes are assessed radiographically at 6 and 12 months after insertion of the fixed prosthesis.
Prosthetic complications are also evaluated.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
10
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Dakahlia Governorate
-
Al Mansurah, Dakahlia Governorate, Egypten
- Faculty of Dentistry, Mansoura University
-
-
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
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
* Completely edentulous patients requiring mandibular implant-supported rehabilitation.
- Adequate bone quantity and quality in the mandibular interforaminal region for implant placement.
- Adequate restorative space for an implant-supported hybrid prosthesis.
- Healthy oral mucosa and acceptable oral hygiene.
- Patients medically fit to undergo implant surgery.
- Ability and willingness to attend the scheduled follow-up visits and provide informed consent.
Exclusion Criteria:
- Systemic conditions or medical contraindications that could interfere with implant surgery or healing.
- History of radiotherapy to the head and neck region.
- Smoking.
- Alcohol abuse.
- Bruxism or clenching habits.
- Any local condition that could compromise implant placement or the planned prosthetic rehabilitation.
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 |
|---|---|
|
Aktiv komparator: Titanium Framework Group
Participants received mandibular All-on-4 implant-supported hybrid prostheses fabricated with a CAD/CAM-milled titanium framework.
|
CAD/CAM-milled titanium framework used for mandibular All-on-4 implant-supported hybrid prosthesis.
|
|
Eksperimentel: Nano-Carbon Framework Group
Participants received mandibular All-on-4 implant-supported hybrid prostheses fabricated with a Nano-carbon fiber-reinforced CAD/CAM framework.
|
Nano-carbon fiber-reinforced CAD/CAM framework used for mandibular All-on-4 implant-supported hybrid prosthesis.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Marginal bone level change
Tidsramme: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
|
Radiographic assessment of changes in peri-implant marginal bone level around the implants in the titanium and nano-carbon framework groups.
|
At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Modified plaque index
Tidsramme: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
|
Assessment of plaque accumulation around the implants using the modified plaque index
|
At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
|
|
Modified gingival index
Tidsramme: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
|
Assessment of peri-implant gingival tissue condition using the modified gingival index
|
At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
|
|
Probing depth
Tidsramme: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
|
Measure of per-implant probing depth around the implants
|
At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
|
|
Bleeding index
Tidsramme: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
|
Assessment of peri-implant bleeding using the bleeding index
|
At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
|
|
prosthetic complications
Tidsramme: up to12 months after prosthesis insertion
|
Assessment of prosthetic complications and maintenance requirements associated with the implant supported prosthesis
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up to12 months after prosthesis insertion
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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)
6. maj 2024
Primær færdiggørelse (Faktiske)
10. august 2026
Studieafslutning (Anslået)
1. februar 2027
Datoer for studieregistrering
Først indsendt
5. september 2026
Først indsendt, der opfyldte QC-kriterier
5. september 2026
Først opslået (Faktiske)
10. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- A0102024RP
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Individual participant data are not planned to be shared because the study was conducted as part of an academic doctoral research project and no data-sharing plan was established in the approved protocol.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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