"Prospective Evaluation of Immediate & Early Loading of Zimmer Hydroxyapatite Coated Dental Implants"

Missing Tooth Clinical Trial

Official title:

Immediate and Early Loading of Hydrothermally Treated, Hydroxyapatite-Coated Dental Implants:a Controlled Randomized Prospective Clinical Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02397044
• Other study ID #: IRB 7438
• Status: Active, not recruiting
• Phase: N/A
• First received: March 18, 2015
• Last updated: March 23, 2015
• Start date: December 2010
• Est. completion date: December 2017

Study information

• Verified date: March 2015
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to compare the success rates of two surgical protocols. One protocol will have the implants placed at the time of tooth extraction and placed into function. The other protocol will have the implants placed into healed extraction sites and placed into function.

Description:

Forty-eight patients (22 men, 26 women) were enrolled in the study and received 48 implants. The population was divided into 2 groups: Group A implants (n=23) were loaded immediately on the day of surgery and Group B implants (n=19) were loaded 3 weeks after surgery. Cone Beam Computed Tomography (CBCT) scans were taken preoperatively to aid in treatment planning. Bone density was evaluated on CBCT scans in Hounsfield units (HU) and by tactile feedback during surgery. Insertion torque was recorded at time of implant placement. Resonance frequency analysis, performed on the day of surgery, at the time of loading, and at 6, 12 and 24 months, was used to record implant stability according to the unit's Implant Stability Quotient (Osstell ISQ). Standardized radiographs were taken at time of implant placement and at 6, 12 and 24 months to measure crestal bone stability. Bone level changes were measured by software (Image J, available online at: http://rsbweb.nih.gov/ij/download.html; last accessed 28 August 2014).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: December 2017
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. May be either male or female

2. Must be at least 18 years of age

3. Must be of sufficiently good health to undergo routine dental treatment. including the surgical procedures associated with placement of dental implants.

4. Must be partially edentulous requiring single dental implants in their maxilla or mandible

5. Must have sufficient amount of native bone or healed bone grafted sites (by socket grafting, maxillary sinus augmentation and ridge augmentation).

6. Must not have any active infection

7. Must have adequate bone height for at least a 10mm long dental implant

8. Must be physically, emotionally and financially able to undergo the surgical procedure planned

9. Must be adequately compliant

Exclusion Criteria:

1. Have any requirements for antibiotic premedication for infective endocarditis, artificial joints or any other condition

2. Have uncontrolled hypertension

3. Have uncontrolled diabetes

4. Are serological HIV positive

5. Have a history of significant heart, stomach, liver, kidney, blood, immune system or other organ impairment or systemic disease that would prevent their undergoing the proposed treatment

6. Smoke cigarettes or use other tobacco products

7. Have taken any investigational drugs anytime in the previous month

8. Have dental conditions likely to require treatment, necessitating exit from the study such as deep cavities, abscesses, or moderate-severe gum disease

9. Have had radiation therapy to the head and neck

10. Are unwilling or unable to sign the informed consent

11. Don't demonstrate willingness to return for a required number of visits

12. Need an immediate dental implant placement following tooth extraction

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anodontia
• Missing Tooth
• Tooth Loss

Intervention

Procedure:
• Implant surgery
Compare surgical protocols

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center in New Orleans	Zimmer Dental

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Endpoint Measurement: Implant survival	The primary endpoint for this protocol is implant survival.	6 months	Yes
Primary	Secondary Endpoint Measurements: Crestal Bone Loss, ISQ	Implant survival; Crestal Bone Loss will be determined radiographically and will be defined as having occurred when greater than 1.5 mm of bone loss is evident. This endpoint will be summarized for the subgroups of the study population which are formed by stratifying on implant diameter, implant length, implant location and patient age. Rates of crestal bone loss will be computed at one year.; ISQ will be measured at the time of implant placement, at 5 months and at one year post implant placement. Insertion torque will be measured at time of placement only.	1 year	Yes