A Prospective Clinical and Radiographic Assessment on New Platform-switched Laser Lok Implants
- Conditions
- Preserve Crestal Bone Level and Gingival Margin Around Dental Implants
- Interventions
- Device: platform-switch tapered internal implants
- Registration Number
- NCT01899131
- Lead Sponsor
- Tel-Aviv Sourasky Medical Center
- Brief Summary
1. 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.
2. To investigate the effect of inter-implant spacing (minimum of 2 or 3 mm) on hard and soft tissues.
3. To perform clinical and radiographic evaluations on these abutment/implant assemblies up to 2 years.
- Detailed Description
* 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
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Male or female, between 20-70 years of age, who request dental implant treatment options for rehabilitation.
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Subjects who are willing to sign an informed consent, participate and return for follow-up visits.
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Subjects without significant medical history and currently not on medications that might complicate the results.
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Subjects presenting with an edentulous area requiring a tooth-replacement option.
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Subjects who do not meet all the inclusion criteria or who will not cooperate with the protocol schedule.
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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.
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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.
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Subjects who have used nicotine-containing products within 3 weeks prior to surgery.
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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).
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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.
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Subjects who have diseases that affect bone metabolism (excluding idiopathic osteoporosis).
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Subjects with a history of an autoimmune disease, documented allergy or multiple allergies to any component of the agents used in this study.
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Acutely infected defect site. 13. Immediate implant site.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description platform-switch tapered internal implants 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
- Primary Outcome Measures
Name Time Method epithelial attachment and bone level around implants 2 years prevent apical migration of the epithelial attachment, and preserve bone level around implant head. radiographic and clinical assessment during recall periods
- Secondary Outcome Measures
Name Time Method inhibit the loss of crestal bone . 2 years preserve the coronal level of bone
Trial Locations
- Locations (1)
Tel Aviv Medical Center
🇮🇱Tel Aviv, Israel