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- Klinische proef NCT01899131
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
- 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).
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Tel Aviv, Israël, 64239
- Tel Aviv Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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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Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: 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
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
epithelial attachment and bone level around implants
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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inhibit the loss of crestal bone .
Tijdsspanne: 2 years
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preserve the coronal level of bone
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2 years
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Amnon Singer, DMD, Tel Aviv Medical Center
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- TASMC 13 AS 177-13-TLV CTIL
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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