- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07588789
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group (Implants types)
Basal Versus Compressive Implant Designs Immediately Loaded With Bar Retained Complete Overdenture for Atrophied Edentulous Mandibular Ridge: Clinical and Radiographic Study of peri_implant Tissue Health
The aim of the present study will be clinical and radio graphical comparison of four basal and compressive implant designs will be installed in the interforamina area of atrophied edentulous mandible and immediately loaded by screw retained mandibular overdenture .
Implant design comparison will be done clinically and radiographically after one and two years of implant loading
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Patients will be divided randomly in to 2 equal groups:
- Group1: this group will receive immediate loaded screw retained complete overdenture supported by 4 basal implants design .
- Group2 :this group will receive immediate loaded screw retained complete overdenture supported by 4 compressive implants design
- After final implant placements, they will be immediately scanned by intraoral scanner to construct milled in titanium bar which will be immediately screwed into the implants
- Mandibular screw retained complete overdenture will be constructed.
Evaluation will be for:
- Peri implant tissue health that will be measured according to mombelli(12) at the time of insertion(T0), 6months(T1) and 12months (T2).
- Marginal bone height changes will be measured using standardized digital panoramic x-ray(13) after 6months (T0), 12month(T1) and 24months(T2) after prosthesis insertion.
- Periotest will evaluate the stability of the implants during implantation (T0) , 3months(T1) and 6months(T3) following surgery(14) .
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Al Mansurah, Egypten
- Faculty of Dentistry Mansoura University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
-
mandibular and maxillary alveolar ridges are completely edentulous (2) There is not sufficient bone in the mandibular posterior molar area to place implants and there is a thin ridge anteriorly (3) skeletal class I maxilla-mandibular relationship (4) Devoid o f any systemic disorders related to bone resorptio
Exclusion Criteria:
- present of systematic disease Chem therapy Bone diseases
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Basal implant Group
Patients in this group will receive four basal implants placed in the atrophied edentulous mandible.
Implants will be immediately loaded using a bar-retained mandibular overdenture.
Clinical and radiographic evaluations will be performed to assess implant stability and peri-implant tissue health over the follow-up period.for
3,6,12months intervventions
|
Placement of four basal dental implants in the atrophied edentulous mandible followed by immediate loading using a bar-retained mandibular overdenture.
Andre navne:
|
|
Eksperimentel: Compressive Dental implant
Patients in this group will receive four compressive implants placed in the atrophied edentulous mandible.
Implants will be immediately loaded using a bar-retained mandibular overdenture.
Clinical and radiographic evaluations will be performed to assess implant stability and peri-implant tissue health over the follow-up period.
|
Placement of four compressive dental implants in the atrophied edentulous mandible followed by immediate loading using a bar-retained mandibular overdenture.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Peri-implant tissue health
Tidsramme: Baseline, 6 months, and 12 months after implant loading.
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Peri-implant tissue health that will be measured according to mombelli for both groups
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Baseline, 6 months, and 12 months after implant loading.
|
|
Marginal bone height changes
Tidsramme: Baseline, 6 months, and 12 months after implant loading.
|
Marginal bone height changes will be measured using standardized digital panoramic x-ray for both groups
|
Baseline, 6 months, and 12 months after implant loading.
|
|
Implant stability
Tidsramme: Baseline, 6 months, and 6 months after implant loading.
|
Periotest will evaluate the stability of the implants during implantation for both groups
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Baseline, 6 months, and 6 months after implant loading.
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Gilan Altonbary, Ass.prof, Mansoura University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MDP.25.06.21
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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