N/A N=47 Randomized Treatment

Mandibular Overdenture Clinical Trial Comparing Parallel Sided and Tapered Dental Implants

Dental Implants

Bottom Line

View on ClinicalTrials.gov: NCT03272828 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcome: Primary: Difference in Implant Failure Rate Between Parallel Sided and Tapered Dental Implants at 5 Years — 1; 2 Participants — p=0.63

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Nobel Biocare titanium dental implants (Device)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Difference in Implant Failure Rate Between Parallel Sided and Tapered Dental Implants at 5 Years	1; 2	0.63
SECONDARY Implant Stability Quotient (ISQ) Measured at 5 Years	80.77; 85.54	0.06
SECONDARY Bone Loss Measurement at 5 Years	1.02; 0.65	0.45

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03272828). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.