- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07657910
Evaluation of Occlusal Contact Distribution in Digitally Fabricated Implant-Retained Fixed Partial Dentures in Mandibular Kennedy Class II Patients Following Artificial Intelligence Bite Optimization: A Quasi-Experimental Study (Quasi)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Noha Walid Barakat, Masters degree
- Telefonnummer: 002 +201149902334
- E-post: noha.barakat@dentistry.cu.edu.eg
Studera Kontakt Backup
- Namn: Ahmed Mustafa Kotb, Lecturer
- Telefonnummer: 002 01006697790
- E-post: ahmed.kotb@dentistry.cu.edu.eg
Studieorter
-
-
-
Giza, Egypten, 12511
- Faculty of Dentistry - Cairo University
-
Kontakt:
- Noha Barakat, Masters degree
- Telefonnummer: 002 01149902334
- E-post: noha.barakat@dentistry.cu.edu.eg
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Patients with a unilateral mandibular distal extension area (Kennedy Class II partially edentulous mandibular arch) and who are indicated for the insertion of 2 implants.
- Fully dentate opposing maxillary arch or restored with a suitable, well constructed fixed prosthesis.
- The remaining teeth should be in good periodontal health, with no signs of inflammation or movement.
- The edentulous area should be covered by a healthy, firm mucoperiosteum, with no or minimal tissue undercut.
- Patient should be with class I occlusion.
- No occlusal disorder; stable jaw relation.
- No TMD signs or symptoms.
- Patients should be in generally good health and free of systemic conditions that can affect the implant treatment, such as diabetes mellitus.
Exclusion Criteria:
- Patients with psychological or mental disorders.
- Patients with insufficient interarch space.
- Patients with parafunctional habits, such as bruxism.
- After the healing phase and exactly before the prosthetic phase, if the inserted implants showed any signs of peri-implantitis or aggressive crestal bone resorption, then this case will be excluded and replaced with another case.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Before
The recruited patients will be screened for proper bone architecture and CBCTs will be taken for proper virtual implant planning.
Two implants will be placed in the edentulous span in all participants.
All surgical steps will be held according to standard protocol.
After the implant osseointegration period, the prosthetic phase will start with implant exposure and placement of multiunit abutments.
After gingival healing, intraoral scans for the implants timing using abutment level scan bodies will be taken.
Then, the fabrication of implant-retained fixed partial denture will be done with a fully digital workflow.
|
The recruited patients will be screened for proper bone architecture and CBCTs will be taken for proper virtual implant planning.
Two implants will be placed in the edentulous span in all participants.
All surgical steps will be held according to standard protocol.
After the implant osseointegration period, the prosthetic phase will start with implant exposure and placement of multiunit abutments.
After gingival healing, intraoral scans for the implants timing using abutment level scan bodies will be taken.
Then, the fabrication of implant-retained fixed partial denture will be done with a fully digital workflow.
|
|
Aktiv komparator: After
The data acquisition will take place by scanning the patients using Medit intraoral scanner.
Then, the scanned stls will be imported in 3shape software version 2024 and bite optimization module in it will be run.
It automatically recalculates the position of the bite relation using its integrated AI.
After that, the resulted STLs will be exported and re-imported to ExoCAD software to design the prostheses.
|
The data acquisition will take place by scanning the patients using Medit intraoral scanner.
Then, the scanned stls will be imported in 3shape software version 2024 and bite optimization module in it will be run.
It automatically recalculates the position of the bite relation using its integrated AI.
After that, the resulted STLs will be exported and re-imported to ExoCAD software to design the prostheses.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Occlusal contact distribution
Tidsram: From enrollment till the end of the study 17 weeks
|
The 1ry outcome will be assessed on the day of the prosthesis delivery. First, the reading of the occlusal contact distribution will be taken by using the T-scan device before seating the prosthesis intraorally. Then, the retained fixed prosthesis will be seated on the implant abutment, and the prosthetic screw will be screwed to the optimum torque. Another reading of the occlusal contact distribution will be taken by using the T-scan device after seating and torquing the prosthesis intraorally. Finally, the screw access channels will be closed by flowable resin composite material. |
From enrollment till the end of the study 17 weeks
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 24226
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