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

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.

Study Overview

• Status: Unknown
• Conditions: Preserve Crestal Bone Level and Gingival Margin Around Dental Implants
• Intervention / Treatment: Device: platform-switch tapered internal implants

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
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amnon Singer, DMD; Phone Number: +97236973676; Email: amnons@tlvmc.gov.il

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Tel Aviv Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Biohorizons platform-switch tapered internal implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
epithelial attachment and bone level around implants	prevent apical migration of the epithelial attachment, and preserve bone level around implant head. radiographic and clinical assessment during recall periods	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inhibit the loss of crestal bone .	preserve the coronal level of bone	2 years

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Amnon Singer, DMD, Tel Aviv Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: June 26, 2013
• First Submitted That Met QC Criteria: July 10, 2013
• First Posted (Estimate): July 15, 2013

Study Record Updates

• Last Update Posted (Estimate): March 27, 2014
• Last Update Submitted That Met QC Criteria: March 26, 2014
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: dental implants; gingival margin; crestal bone
• Other Study ID Numbers: TASMC 13 AS 177-13-TLV CTIL