Plain English Summary
Background and study aims
Losing teeth is an inevitable part of the aging process for some people. The gaps left by missing teeth can cause problems with eating or speech, as well as affecting appearance, which can be distressing for the sufferer. Dentures are removable false teeth designed to replace missing teeth. They can be complete (a full set), for someone has lost all the teeth on the upper and/or lower jaw or partial, which replace just one tooth or several missing teeth. They typically consist of an acrylic (plastic), nylon or metal plate with false teeth attached, that can be slotted into place. In the case of partial dentures, connectors (metal clips) are often used to hold the dentures in the mouth securely, by clipping onto natural teeth. In recent years titanium has been used far more in the manufacture of these connectors, as it is very flexible, strong and long-lasting. The aim of this study is to compare how using titanium alloy and the traditional metal cobalt-chromium for dentures affects long-term tooth and gum health.
Who can participate?
Healthy men over 55 years of age who have lost some of their teeth.
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group receive dentures with connectors constructed from titanium alloy (Ta) to wear during waking hours throughout the two years of the study. Participants in the second group receive dentures with connectors constructed from chrome cobolt (Co-Cr) to wear during waking hours throughout the two years of the study. After 6, 12, 18 and 24 months, participants in both groups have a dental examination to find out how the dentures have affected their teeth and gums.
What are the possible benefits and risks of participating?
Participants benefit from receiving free dental treatment during this study. There are no expected risks of taking part in this study.
Where is the study run from?
Al-Azhar University-Assiut Branch (Egypt)
When is the study starting and how long is it expected to run for?
January 2013 to January 2015
Who is funding the study?
Albaha University (Saudi Arabia)
Who is the main contact?
Professor Khalid Arafa
Titanium alloy and chrome cobalt in removable partial denture connectors with tooth mobility, bone loss and tissue reaction
Titanium alloy is better than chrome cobalt for fabricating the major connectors in removable partial dentures
Dental Health Department of the Faculty of Applied Medical Sciences (Albaha University), 02/01/2013
Non-randomized clinical-controlled trial
Primary study design
Secondary study design
Non randomised study
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Removable partial dentures
The patients enrolled in the study were separated into two equal groups.
Group 1: Participants receive connectors constructed from titanium alloy (Ta). The Ta (Ti-6Al-4V alloy disks; Sumitomo Steel, Osaka, Japan, 120 mm in diameter and 0.75 mm in thickness). After construction of the partial denture, the patients wore the dentures. During mastication, the forces were transmitted from the dentures to the tooth structure and the residual ridge.
Group 2: Participants receive connectors constructed from chrome cobolt (Co-Cr). The Co–Cr (Co-63% Cr-30% Mo-7%) American Element, Los Angeles, CA 90024) were used in this study. After construction of the partial denture, the patients wore the dentures. During mastication, the forces were transmitted from the dentures to the tooth structure and the residual ridge.
Participants in both groups are followed up by measuring the tooth mobility, bone loss and tissue reduction four times after insertion with 6 moths intervals (6, 12, 18, and 24 months).
Primary outcome measures
Tooth mobility is measured in mm using the Miller index at 6, 12, 18 and 24 moths.
Secondary outcome measures
1. Bone loss is measured by measuring the tooth height subjectively in millimeters (mm) for each tooth at 6, 12, 18 and 24 months
2. Dental tissue reduction is assessed using the Benson and Spolky index at 6, 12, 18 and 24 months
Overall trial start date
Overall trial end date
Participant inclusion criteria
2. Aged 55 years or olde
3. Partially edentulous
4. Free from disabilities or chronic conditions, such as diabetes
Target number of participants
Participant exclusion criteria
1. Diabetic patients
2. Fully edentulous
3. Those who neglected oral hygiene
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Al-Azhar University-Assiut Branch
Dental Clinic Faculty of Dentistry
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication of results data in a dental journal.
Intention to publish date
Participant level data
Available on request
Results - basic reporting