Clinical trial NCT01899131: A Prospective Clinical and Radiographic Assessment on New Platform-switched Laser Lok Implants
Official title: A Prospective Clinical and Radiographic Assessment on New Platform-switched Laser Lok Implants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preserve Crestal Bone Level and Gingival Margin Around Dental Implants
Keywords: dental implants
crestal bone
gingival margin
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-07-15
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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.

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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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Primary outcomes:
measure: epithelial attachment and bone level around implants
timeFrame: 2 years
Secondary outcomes:
measure: inhibit the loss of crestal bone .
timeFrame: 2 years
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
Study officials:
affiliation: Tel Aviv Medical Center
name: Amnon Singer, DMD
role: PRINCIPAL_INVESTIGATOR
References: