A Prospective Clinical and Radiographic Assessment on New Platform-switched Laser Lok Implants
- To investigate the hard and soft tissue adaptation and maintenance to the Laser-Lok® microchannels permanent abutment/ new Laser-Lok® implant assembly by performing clinical and radiographic evaluations.
- To investigate the effect of inter-implant spacing (minimum of 2 or 3 mm) on hard and soft tissues.
- To perform clinical and radiographic evaluations on these abutment/implant assemblies up to 2 years.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
- Screening (Inclusion/ Exclusion Criteria)
- Day of Surgery: Dental CT scan/ periapical radiograph / clinical picture / clinical examination (probing depth, BOP, gingival recession).
- Implant Restoration Day: Post-restoration periapical radiograph/ clinical picture/ clinical examination (probing depth, BOP, gingival recession).
- 6 month, 1 Year and 2 Year Post Restoration: periapical radiograph / clinical picture / clinical examination (probing depth, BOP, gingival recession).
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Tel Aviv, Israele, 64239
- Tel Aviv Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:1. Male or female, between 20-70 years of age, who request dental implant treatment options for rehabilitation.
2. Subjects who are willing to sign an informed consent, participate and return for follow-up visits.
3. Subjects without significant medical history and currently not on medications that might complicate the results.
4. Subjects presenting with an edentulous area requiring a tooth-replacement option.
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Exclusion Criteria:1. Subjects who do not meet all the inclusion criteria or who will not cooperate with the protocol schedule.
2. Subjects who received and failed a previously placed dental implant. 3. Subjects who require an onlay ridge augmentation procedure in the area to achieve adequate bone volume for the placement of dental implants.
4. Subjects who have significant untreated periodontal disease, caries, infection or chronic inflammation in the oral cavity within two adjacent tooth positions of the clinical trial area.
5. Subjects who have used nicotine-containing products within 3 weeks prior to surgery.
6. Subjects who are insulin-dependent diabetic or if their Hgb1c levels > 6.5%. 7. Subjects who have had a history of malignancy within the past 5 years (except for basal or squamous cell carcinoma of the skin or in situ cervical carcinoma).
8. Subjects who are nursing or pregnant. 9. Subjects who are presently taking medications (except estrogen/progesterone therapy) or those who are undergoing treatment that in known to have an effect on bone turnover.
10. Subjects who have diseases that affect bone metabolism (excluding idiopathic osteoporosis).
11. Subjects with a history of an autoimmune disease, documented allergy or multiple allergies to any component of the agents used in this study.
12. Acutely infected defect site. 13. Immediate implant site.
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Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: platform-switch tapered internal implants
2 platform-switch tapered internal implants placed in 10 participants.clinical
and radiographic assessment in 6,12,24, month post implant insertion
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Laser-Lok permanent abutment/ new Laser Lok platform-switch implant assembly.assessment
at 6,12,24 month clinicaly and radiographic
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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epithelial attachment and bone level around implants
Lasso di tempo: 2 years
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prevent apical migration of the epithelial attachment, and preserve bone level around implant head.
radiographic and clinical assessment during recall periods
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2 years
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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inhibit the loss of crestal bone .
Lasso di tempo: 2 years
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preserve the coronal level of bone
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2 years
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Amnon Singer, DMD, Tel Aviv Medical Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- TASMC 13 AS 177-13-TLV CTIL
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su platform-switch tapered internal implants
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Implantology InstituteSconosciutoPerdita di massa ossea | ImpiantiPortogallo