NCT02387970

Immediate or Delayed Provisionalization in Posterior Healed Sites

Non-inferiority Study of Immediate or Delayed Provisionalization at Posterior Healed Sites Using NobelParallelCC Implants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, the investigators will examine the performance of a new dental implant that has been approved by the Food and Drug Administration for use to replace of missing teeth. The investigators will study two groups of patients: one group will receive a temporary crown to replace the missing tooth at the same day as implant surgery; the second group will receive a similar crown 3 months later. Both groups will receive a permanent crown on the implant 4 months after surgery, and will be followed up for a period of 12 months. The investigators want to examine whether the healing of the bone and gums surrounding the implant that receives a crown immediately is similar to the healing of the implant when the crown is delivered later. If this is indeed the case, then the investigators will be able to recommend faster treatment for all patients.

Detailed description

Dental implants are a widely used treatment option for the replacement of lost teeth due to trauma or oral diseases. The original protocol for placement of dental implants in edentulous spaces in the maxilla or the mandible was introduced more than thirty years ago and called for a two-stage approach, i.e., surgical placement of submerged dental implants and subsequent uncovering with abutment connection, prosthesis fabrication and functional loading approximately 6 months after. Today, the time between surgery and loading in a two-stage protocol has been commonly abbreviated to 3-4 months, while immediate implant provisionalization has emerged as a reliable and predictable option in cases of adequate osseous support, having similar survival and success rates to the two-step procedure. Comparison of histological healing has demonstrated no significant differences in bone to implant contact between implants surgically placed according to a two-stage protocol and those immediately provisionalized. However, substantial variability was noted among the clinical protocols used in the studies carried out so far, and additional well-designed randomized controlled trials (RCTs) are needed to fully appreciate the clinical outcomes of immediate and early loading protocols. The design of dental implants is a subject of continuous improvement, and implant manufacturers regularly introduce new products the use of which may result in accelerated soft and hard tissue healing, increased initial implant stability, and enhanced aesthetic outcomes. The purpose of this randomized, controlled trial is to compare treatment outcomes when using a newly-introduced dental implant (NobelParallel™ CC) in a one-stage or a two-stage protocol. This new implant has the same titanium oxide surface coating (TiUnite®) and the same design principles of the parallel-walled NobelSpeedy Groovy™ implants, and an internal conical connection. The implant is marketed under the premarket notifications K050406 and K073142 (510(k), Food and Drug Administration).

Conditions

• Partial Edentulism

Interventions

Type	Name	Description
PROCEDURE	Immediate provisionalization	Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.
PROCEDURE	Delayed provisionalization	Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.
DEVICE	NobelParallel CC implant	Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
DEVICE	Dental crown	A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.

Timeline

• Start date: 2015-03-01
• Primary completion: 2019-02-13
• Completion: 2019-02-13
• First posted: 2015-03-13
• Last updated: 2023-03-06
• Results posted: 2020-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study