- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07663045
Qualitative and Quantitative Assessment of Marginal Bone Loss Following Flapless Guided Versus Conventional Implant Placement
Qualitative and Quantitative Assessment of Marginal Bone Loss Following Flapless Guided Versus Conventional Implant Placement Using Cone Beam Computed Tomography - A Split-Mouth Randomized Controlled Trial.
Marginal bone preservation is an important determinant of long-term implant success. Conventional flap implant placement provides direct visualization of the surgical site but may disturb the periosteal blood supply and contribute to early crestal bone remodeling.
Flapless guided implant placement is a minimally invasive approach that aims to preserve soft tissue architecture and vascular integrity. CBCT allows three-dimensional evaluation of peri implant bone levels, including mesial, distal, buccal, and lingual aspects.
Aim: The aim of this study was to compare flapless guided implant placement with conventional flap implant placement in terms of marginal bone loss, implant stability, postoperative pain, and soft-tissue healing.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Ajman Emirate
-
Ajman, Ajman Emirate, Forenede Arabiske Emirater, 00000
- Gulf Medical University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Patients aged 20 years or older.
- Patients requiring at least two dental implants within the same arch.
- Patients with good general health and able to undergo oral surgery.
- Patients willing to participate in the study and provide informed consent.
- Patients with adequate bone volume for implant placement as determined by preoperative radiographic assessment (e.g., cone beam computed tomography).
Exclusion criteria:
- Patients with systemic diseases that could compromise healing or implant success (e.g., uncontrolled diabetes, immunocompromised conditions).
- Patients with a history of radiation therapy to the head and neck region.
- Patients with active periodontal disease or untreated oral infections.
- Patients who are pregnant or breastfeeding.
- Patients with a history of bisphosphonate therapy or other medications that may affect bone metabolism.
- Smoker Patients with a history of smoking or heavy alcohol consumption.
- Patients with unrealistic expectations or inability to comply with postoperative care instructions.
- Patients with significant facial trauma or anatomical deformities affecting the implant site.
- Patient who requires Immediate implant placement
- Thin gingival biotype
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Flapless Guided Implant Placement
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a minimally invasive dental implant procedure where a surgical guide, often created using advanced imaging techniques like cone-beam computed tomography (CBCT) and computer-aided design (CAD), directs the precise placement of dental implants without the need for traditional flap elevation.
|
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Eksperimentel: Conventional Flap Implant Placement
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manually raising the gingival tissue during dental implant surgery, this surgical procedure involves the placement of a dental implant directly into the alveolar or basal bone during a single session followed by the placement of a healing abutment without the use of surgical guides or advanced technology.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Marginal Bone Loss
Tidsramme: baseline, 3 months, 6 months
|
CBCT assessment
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baseline, 3 months, 6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Implant Stability ISQ
Tidsramme: baseline, 3 months, 6 months
|
Implant stability was assessed as a secondary outcome using Resonance Frequency Analysis (RFA), which provides an objective and non-invasive measurement of implant stability expressed as the Implant Stability Quotient (ISQ).
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baseline, 3 months, 6 months
|
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Postoperative Pain Assessment VAS scale 0-10
Tidsramme: baseline, Day 2 Day 3 Day 4 Day 5
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VAS scale 0-10
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baseline, Day 2 Day 3 Day 4 Day 5
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
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
Nøgleord
Andre undersøgelses-id-numre
- AbdallahMDSperio
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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