Mandibular Overdenture Clinical Trial Comparing Parallel Sided and Tapered Dental Implants

A Prospective Randomized Study on the Immediate Loading of Mandibular Overdentures Supported by Parallel Sided or Tapered Dental Titanium Implants

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.

Study Overview

• Status: Completed
• Conditions: Dental Implants
• Intervention / Treatment: Device: Nobel Biocare titanium dental implants

Detailed Description

Titanium dental implants have been frequently used in the rehabilitation of edentulous patients. Implants may provide adequate denture stability, improve oral function and oral health related quality of life. There is evidence that implants supporting fixed and removable prostheses have excellent long term success rates. Factors such as implant surface characteristics, length, diameter and shape (parallel sided or tapered) may play and important role for the outcome of the treatment especially when the immediate loading protocol (loading of the implant the same day it is surgically placed) is utilized. There are reports indicating that dental implants placed according to the immediate loading protocol can be used to support removable prostheses in the mandible. Such protocol would minimize the number of surgical procedures and significantly shorten the overall treatment time. Further, increased oral health related quality of life has been reported from studies on mandibular implant overdentures. Traditionally two implants have been suggested for the support of a mandibular overdenture. However, high patient satisfaction rates and appropriate denture retention have been reported among patients with a single implant placed in the mid-line. It is also important to further evaluate and compare various implant designs to determine clinical outcomes. The two dominating types of implant body design on the market are the parallel-sided (straight) and the tapered (conical) shaped. Both implants have similar threads, and the surgical procedure for placing the implants in the bone tissue is similar, but the drills used have a slightly different design and shape. There are today no randomized controlled studies evaluating differences in outcomes with respect to the external implant design i.e. parallel sided or tapered.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98025
      • the Regional Research Clinic, School of Dentistry at the University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Parallel sided implant Group; A Parallel sided titanium dental implant will be placed in the edentulous mandible.	Device: Nobel Biocare titanium dental implants
Active Comparator: Tapered shaped implant Group; A tapered shaped titanium dental implant will be placed in the edentulous mandible.	Device: Nobel Biocare titanium dental implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Stability Quotient (ISQ) Measured at 5 Years	The implant stability quotient (ISQ) value is a measurement of the mechanical implant stability in the bone and is measured directly after surgical implant placement and then at follow-ups. It is obtained by resonance frequency with a device that sends out a signal to a metal rod placed in the implant and then reads the value of the signal when it bounces back. The value ranges from 0 to 100 with higher values indicating better bone-to-implant contact and greater stability.	5 years
Bone Loss Measurement at 5 Years	The measure of bone loss in millimeters (mm) around the implant at 5 years compared to bone height at baseline. Changes in bone level are measured on intraoral radiographs and compared with the bone level measure immediately after surgical implant placement (baseline). The implant platform was used as the reference point and measurements of the bone were made to the nearest thread. The bone level is measured on both sides (mesial & distal) of the implant using the thread on the implant as reference. The distance between the threads is 0.6 mm.	From implant placement (baseline) to 5 years

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Mats Kronstrom, DDS, PhD, University of Washington

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2012
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): August 3, 2023

Study Registration Dates

• First Submitted: September 2, 2017
• First Submitted That Met QC Criteria: September 2, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00003063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participant Data (IPD) will not be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No