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
drkhalidarafa@yahoo.com
Trial website
Contact information
Type
Scientific
Primary contact
Prof Khalid Arafa
ORCID ID
http://orcid.org/0000-0002-3597-5073
Contact details
Dental Health Department
Faculty of Applied Medical Sciences
Albaha University
Al-Baha
00966
Saudi Arabia
+966 553 388866
drkhalidarafa@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Titanium alloy and chrome cobalt in removable partial denture connectors with tooth mobility, bone loss and tissue reaction
Acronym
Study hypothesis
Titanium alloy is better than chrome cobalt for fabricating the major connectors in removable partial dentures
Ethics approval
Dental Health Department of the Faculty of Applied Medical Sciences (Albaha University), 02/01/2013
Study design
Non-randomized clinical-controlled trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Removable partial dentures
Intervention
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).
Intervention type
Procedure/Surgery
Phase
Drug names
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
01/01/2013
Overall trial end date
05/01/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male
2. Aged 55 years or olde
3. Partially edentulous
4. Free from disabilities or chronic conditions, such as diabetes
Participant type
Patient
Age group
Senior
Gender
Male
Target number of participants
80
Participant exclusion criteria
1. Diabetic patients
2. Fully edentulous
3. Those who neglected oral hygiene
Recruitment start date
10/01/2013
Recruitment end date
01/01/2015
Locations
Countries of recruitment
Egypt
Trial participating centre
Al-Azhar University-Assiut Branch
Dental Clinic
Faculty of Dentistry
Assuit
71524
Saudi Arabia
Funders
Funder type
University/education
Funder name
Albaha University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication of results data in a dental journal.
Intention to publish date
30/06/2016
Participant level data
Available on request
Results - basic reporting
Publication summary