Status:
UNKNOWN
A Prospective Clinical and Radiographic Assessment on New Platform-switched Laser Lok Implants
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
Preserve Crestal Bone Level and Gingival Margin Around Dental Implants
Eligibility:
All Genders
20-70 years
Phase:
NA
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 evalua...
Detailed Description
* Screening (Inclusion/ Exclusion Criteria) * Day of Surgery: Dental CT scan/ periapical radiograph / clinical picture / clinical examination (probing depth, BOP, gingival recession). * Implant Restor...
Eligibility Criteria
Inclusion
- 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.
- \-
Exclusion
- 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.
- \-
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01899131
Start Date
October 1 2013
End Date
June 1 2016
Last Update
March 27 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tel Aviv Medical Center
Tel Aviv, Israel, 64239