- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07775443
Comparative Assessment of Primary Stability in Double, and Triple Thread Implant Designs (1th stability)
Comparative Assessment of Primary Stability in Double, and Triple Thread Implant Designs in the Posterior Maxilla
The goal of this randomized clinical trial is to compare the primary stability of double-thread and triple-thread dental implant designs in patients requiring implant placement in the posterior maxilla.
The main question it aims to answer is whether implant thread design influences primary implant stability in the posterior maxilla.
Participants will be randomly assigned to one of two groups. Group A will receive a double-thread dental implant, while Group B will receive a triple-thread dental implant. Primary implant stability will be assessed at the time of implant placement using insertion torque and resonance frequency analysis (ISQ).implant stability using ISQ will also be evaluated at 3 months
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: falah M Alshahrani, BDS
- Telefonnummer: 00966599224538 0561554512
- E-post: alhmadflah@gmail.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Patients aged 20-55 years.
- Medically healthy individuals without any systemic disease that affects bone healing (e.g., uncontrolled diabetes, osteoporosis).
- Patients requiring dental implants in the posterior maxilla.
- Adequate bone volume for implant placement.
- Signed informed consent for participation in the study.
Exclusion Criteria:
- Smokers (due to the potential negative impact on bone healing and implant success).
- Pregnant or breastfeeding women.
- Patients with a history of radiotherapy or chemotherapy.
- Patients with severe periodontal disease.
- Individuals with a history of allergic reactions to implant materials.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Double-Thread Implant Group
Participants assigned to this arm will receive a double-thread dental implant in the posterior maxilla
|
Participants assigned to this group will receive a double-thread dental implant placed in the posterior maxilla.
Primary implant stability will be assessed at the time of implant placement using insertion torque and resonance frequency analysis (ISQ).
|
|
Eksperimentell: Triple-thread implant
Participants assigned to this group will receive a triple-thread dental implant placed in the posterior maxilla.
Primary implant stability will be assessed at the time of implant placement using insertion torque and resonance frequency analysis (ISQ).
|
Participants assigned to this group will receive a triple-thread dental implant placed in the posterior maxilla.
Primary implant stability will be assessed at the time of implant placement using insertion torque and resonance frequency analysis (ISQ).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
insertion torque
Tidsramme: at the time of implant placement T0
|
The primary outcome of this study will be the insertion torque, expressed in Newton-centimeter (Ncm).
Measurements will be performed using a surgical motor/torque wrench and recorded at the time of implant placement (T0).
|
at the time of implant placement T0
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
implant stability (ISQ)
Tidsramme: 3 months
|
The first secondary outcome will be the assessment of implant stability (ISQ) using the Osstell ISQ device. The measurements will be expressed on the ISQ scale (1-100) and recorded at the time of implant placement (T0). The second secondary outcome will also be the evaluation of implant stability (ISQ), assessed with the Osstell ISQ device on the ISQ scale (1-100), but recorded at 3 months, corresponding to the prosthetic stage |
3 months
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- (91)/11-2025
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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