Mandibular Overdenture Clinical Trial Comparing Parallel Sided and Tapered Dental Implants

NCT03272828 | Completed Results FDA Device

• 1 other identifier: STUDY00003063
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to compare two different types of dental implants which will be used to support/retain a removable denture in the edentulous mandible. Subjects will have one implant placed in the midline of the mandible after which the patient's existing denture will be modified to fit the implant. The population of this study consists of healthy edentulous individuals 20-75 years of age who have complete dentures in the upper and lower arch.

Conditions

Dental Implants

Outcome Measures

Primary Outcomes (1)

• Difference in Implant Failure Rate Between Parallel Sided and Tapered Dental Implants at 5 Years

  Implant failure defined as an implant that has lost osseointegration and no longer is stable and supported by the surrounding bone (no bone to implant contact).

  From implant placement (baseline) to 5 years

Secondary Outcomes (2)

• Implant Stability Quotient (ISQ) Measured at 5 Years

  5 years

• Bone Loss Measurement at 5 Years

  From implant placement (baseline) to 5 years

Study Arms (2)

Parallel sided implant Group

ACTIVE COMPARATOR

A Parallel sided titanium dental implant will be placed in the edentulous mandible.

Device: Nobel Biocare titanium dental implants

Tapered shaped implant Group

ACTIVE COMPARATOR

A tapered shaped titanium dental implant will be placed in the edentulous mandible.

Device: Nobel Biocare titanium dental implants

Interventions

Nobel Biocare titanium dental implants DEVICE

Parallel sided implant Group; Tapered shaped implant Group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between 20 and 75 years of age
• Be edentulous and have both upper and lower complete dentures
• Present with American Society of Anesthesiologists (ASA) I or ASA II and no medical contraindications to implant treatment
• Have adequate bone volume for placement of one (1) 4.0 mm diameter titanium dental implant with a minimum length of 10 mm in the symphyseal area (=midline) of the anterior mandible
• Show absence of pathology such as cysts, infections in the gum tissue or bone and remaining roots.
• Be able to understand the procedures and have a jaw opening range of 30 mm or more

You may not qualify if:

• Ongoing chemotherapy
• Previous radiation to head/neck
• Ongoing corticosteroid medication
• Ongoing blood thinner medication
• Ongoing medication with psychopharmacological drugs
• History of alcohol/drug abuse
• Remaining teeth/root tips
• Poor quality /fractured/severely worn dentures that cannot be modified to fit the implant
• Jaw opening range less than 30 mm

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

the Regional Research Clinic, School of Dentistry at the University of Washington

Seattle, Washington, 98025, United States

Location

Related Publications (1)

• Kronstrom M, Davis B, Loney R, Gerrow J, Hollender L. Satisfaction and Clinical Outcomes Among Patients with Immediately Loaded Mandibular Overdentures Supported by One or Two Dental Implants: Results of a 5-Year Prospective Randomized Clinical Trial. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):128-136. doi: 10.11607/jomi.4824.

  PMID: 28095527 BACKGROUND

Results Point of Contact

• Title: Dr. Mats Kronstrom
• Organization: University of Washington

mk33@uw.edu

425-877-7345

Study Officials

• Mats Kronstrom, DDS, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Restorative Dentistry

Study Record Dates

• First Submitted: September 2, 2017
• First Posted: September 6, 2017
• Study Start: June 15, 2012
• Primary Completion: December 30, 2022
• Study Completion: August 3, 2023
• Last Updated: January 9, 2024
• Results First Posted: January 9, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)