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Immediate or Delayed Provisionalization in Posterior Healed Sites

NCT02387970 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-03-06

Study results available
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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.

Conditions

  • Partial Edentulism

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Panos N Papapanou, DDS, PhD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2019-02-13
Completion
2019-02-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02387970 on ClinicalTrials.gov