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A Prospective Clinical and Radiographic Assessment on New Platform-switched Laser Lok Implants

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ClinicalTrials.gov Identifier: NCT01899131
Recruitment Status : Unknown
Verified June 2013 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 15, 2013
Last Update Posted : March 27, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Preserve Crestal Bone Level and Gingival Margin Around Dental Implants Device: platform-switch tapered internal implants Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Clinical and Radiographic Assessment on New Platform-switched Laser Lok Implants
Study Start Date : October 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2016

Arm Intervention/treatment
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
Device: platform-switch tapered internal implants
Laser-Lok permanent abutment/ new Laser Lok platform-switch implant assembly.assessment at 6,12,24 month clinicaly and radiographic
Other Name: Biohorizons platform-switch tapered internal implants



Primary Outcome Measures :
  1. epithelial attachment and bone level around implants [ Time Frame: 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 :
  1. inhibit the loss of crestal bone . [ Time Frame: 2 years ]
    preserve the coronal level of bone



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899131


Contacts
Contact: Amnon Singer, DMD +97236973676 amnons@tlvmc.gov.il

Locations
Israel
Tel Aviv Medical Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Amnon Singer, DMD Tel Aviv Medical Center

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01899131     History of Changes
Other Study ID Numbers: TASMC 13 AS 177-13-TLV CTIL
First Posted: July 15, 2013    Key Record Dates
Last Update Posted: March 27, 2014
Last Verified: June 2013

Keywords provided by Tel-Aviv Sourasky Medical Center:
dental implants
crestal bone
gingival margin