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

NCT02397044 | Unknown

• 1 other identifier: IRB 7438
• Study Type: observational
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Missing Tooth

Keywords

Implants, stability, loading

Outcome Measures

Primary Outcomes (2)

• Primary Endpoint Measurement: Implant survival

  The primary endpoint for this protocol is implant survival.

  6 months

• 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

Study Arms (2)

Implant loading Immediate

Dental implant surgery with immediate loading

Procedure: Implant surgery

Implant Loading Early

Dental implant surgery with delayed loading

Procedure: Implant surgery

Interventions

Implant surgery PROCEDURE

Compare surgical protocols

Implant Loading Early; Implant loading Immediate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy volunteers over the age of 18 needing a tooth replacement.

You may qualify if:

• May be either male or female
• Must be at least 18 years of age
• Must be of sufficiently good health to undergo routine dental treatment. including the surgical procedures associated with placement of dental implants.
• Must be partially edentulous requiring single dental implants in their maxilla or mandible
• Must have sufficient amount of native bone or healed bone grafted sites (by socket grafting, maxillary sinus augmentation and ridge augmentation).
• Must not have any active infection
• Must have adequate bone height for at least a 10mm long dental implant
• Must be physically, emotionally and financially able to undergo the surgical procedure planned
• Must be adequately compliant

You may not qualify if:

• Have any requirements for antibiotic premedication for infective endocarditis, artificial joints or any other condition
• Have uncontrolled hypertension
• Have uncontrolled diabetes
• Are serological HIV positive
• 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
• Smoke cigarettes or use other tobacco products
• Have taken any investigational drugs anytime in the previous month
• Have dental conditions likely to require treatment, necessitating exit from the study such as deep cavities, abscesses, or moderate-severe gum disease
• Have had radiation therapy to the head and neck
• Are unwilling or unable to sign the informed consent
• Don't demonstrate willingness to return for a required number of visits
• Need an immediate dental implant placement following tooth extraction

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• Zimmer Dental: collaborator

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• David E Simmons, D.D.S.

  LSU Helath Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Department of Periodontics

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 24, 2015
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2017
• Last Updated: March 24, 2015

Record last verified: 2015-03