Osseotite Certain Prevail for the Preservation of Crestal Bone

Status Recruiting

Clinical Trial Summary

A potential complicating factor affecting implants is crestal bone loss. The causes of crestal bone loss are attributed to several factors. Among those hypothesized, proof for one or another cause remains obscure. Clinical documentation suggests that implant design may be a key factor. While the evidence is inconclusive, various authors suggest that it is a result of a combination of effects including (1) limited drilling procedure and restricted second-stage surgery 2, (2) rough implant surface in crestal bone 3, (3) microthread design for implant stiffness 4, (4) loading along a conus versus a flat interface 5, and (5) the absence of a significant microgap 6.

The practice of platform switching (e.g. placing a 4 mm diameter abutment on a 5 mm implant seating surface physically moves the inflammatory cell infiltrate zone away from the crestal bone). The growing body of anecdotal platform switch evidence supports this biological width hypothesis. Here the biological width refers to the height of the dento-gingival attachment apparatus around a normal tooth and is defined as the distance necessary for a healthy existence of bone and soft tissue from the most apical extent of a dental restoration.

To formally test this hypothesis the current study has been designed. The Prevail implant has been made with an integrated medialized seating surface that establishes a platform switching function. This implant moves the implant/abutment interface away from the crestal bone and may therefore reduce the amount of bone loss observed in the standard (non-medialized) Osseotite implant design. The objective of this study is to evaluate crestal bone levels adjacent to the implant reference point from the time of implant placement to a period of two years after loading.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01611493
Study type	Interventional
Source	CES University
Contact	Andres Duque, MSc
Phone	(0574)444055
Email	aduqued@ces.edu.co
Status	Recruiting
Phase	Phase 3
Start date	March 2011
Completion date	September 2013

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02880891` - Effects of Splinted or Non-splinted Single-unit Crowns on Marginal Bone-level Alterations Around Implants	N/A
Completed	`NCT00748241` - Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-stage Surgery and Early Loading	N/A
Active, not recruiting	`NCT04066309` - Implant Retained Rehabilitation With Surgical and Prosthetic Digital Workflow	N/A
Active, not recruiting	`NCT04545840` - Prospective Neodent® Zirconia System Study
Active, not recruiting	`NCT06034067` - Osseodensification Versus Conventional Drilling for Implant Site Preparation	N/A
Active, not recruiting	`NCT04546269` - Fully Guided Versus Conventionally Guided Implant Placement by Dental Students	N/A
Recruiting	`NCT02662361` - Evaluation of the Prevalence and Risk Factors for Patients With Peri-implant Disease：a Retrospective Study	N/A
Recruiting	`NCT02676661` - Evaluation of the Prevalence and Risk Factors for Patients With Peri-implant Disease	N/A
Completed	`NCT01030523` - Short Implants - An Alternative to Bone Grafting?	N/A
Completed	`NCT00906425` - Clinical Study Comparing Submerged Versus Trans-mucosal Healing of P.004 Implants in the Anterior Mandible and Maxilla	N/A
Completed	`NCT03252106` - Long-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement	N/A
Completed	`NCT02975674` - Evaluation of MT-12 Implant Survival and Marginal Bone Loss	N/A
Completed	`NCT01822223` - A Study to Evaluate the Effectiveness of Laser-Ablated Implant-Abutments to Promote Tissue Healing	N/A
Completed	`NCT00545818` - Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw	N/A
Completed	`NCT00900822` - Straumann Bone Ceramic Versus BioOss in Sinus Elevation	N/A
Completed	`NCT04017026` - Survival and Success Rates of 6mm Implants With a Micro-rough Surface After 4.5 - 18.2 Years in Function
Active, not recruiting	`NCT05315414` - Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations	N/A
Recruiting	`NCT02814149` - Esthetic, Clinical and Radiographic Outcomes of Immediate and Delayed Implant Placement	N/A
Active, not recruiting	`NCT03319758` - Esthetic and Radiographic Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall	N/A
Completed	`NCT01807416` - Bone Dimensional Changes at Different Implant-to-abutment Connections: a 1-year Clinical and Radiological Study	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Osseotite Certain Prevail for the Preservation of Crestal Bone — OCPTI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms