Triple-Scan Protocol to Assess Passivity
Triple-Scan Protocol for Evaluating Passivity of Complete-Arch Implant-Supported Fixed Prostheses: A Randomized Clinical Study
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Al Mansurah, Egypten
- Alaa Mohamed Barakat Elazaly
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
Reduced patient satisfaction regarding the stability and retention of conventional mandibular dentures due to mandibular ridge atrophy.
Completely edentulous maxillary and mandibular arches for at least 1 year. Sufficient bone volume for placement of four mandibular implants without the need for bone grafting.
Age between 45 and 64 years. Ability and willingness to provide informed consent and comply with study procedures.
Exclusion Criteria:
Current smoking habit. Bone metabolic diseases that may affect osseointegration. History of radiotherapy to the head and neck region within the previous 3 years.
Systemic conditions or medications that could compromise implant healing. Inability to attend follow-up visits or comply with study requirements.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Sequence A
Participants received the three impression techniques in the following order: Conventional Impression Technique Digital Impression with Nonmodified Scan Body Digital Impression with Modified Scan Body |
Conventional implant impression using impression copings and elastomeric impression material.
Digital implant impression obtained using nonmodified implant scan bodies
Digital implant impression obtained using subtractively modified implant scan bodies
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Aktiv komparator: Sequence B
Participants received the three impression techniques in the following order: Digital Impression with Nonmodified Scan Body Digital Impression with Modified Scan Body Conventional Impression Technique |
Conventional implant impression using impression copings and elastomeric impression material.
Digital implant impression obtained using nonmodified implant scan bodies
Digital implant impression obtained using subtractively modified implant scan bodies
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Aktiv komparator: Sequence C
Participants received the three impression techniques in the following order: Digital Impression with Modified Scan Body Conventional Impression Technique Digital Impression with Nonmodified Scan Body |
Conventional implant impression using impression copings and elastomeric impression material.
Digital implant impression obtained using nonmodified implant scan bodies
Digital implant impression obtained using subtractively modified implant scan bodies
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Mean horizontal misfit (µm)
Tidsramme: Day 1
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Mean horizontal misfit using the triple-scan protocol and STL file superimposition in software.
Results will be reported in micrometers (µm).
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Day 1
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Mean vertical misfit (µm)
Tidsramme: Day 1
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Mean vertical misfit using the triple-scan protocol and STL file superimposition in software.
Results will be reported in micrometers (µm).
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Day 1
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- R.25.09.24
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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