Condition category
Oral Health
Date applied
10/12/2015
Date assigned
15/12/2015
Last edited
15/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Albaha University

Sponsor details

The Faculty of Applied Medical Sciences
Prince Mohammad Bin Saud
Al-Baha
00966
Saudi Arabia

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes