Plain English Summary
Background and study aims
Overdentures, also known as dental implants, are metal posts which are screwed directly into the jaw bone in order to support replacement teeth. These implants provide a strong foundation for fixed (permanent) or removable false teeth and, as long as they are looked after well, are very long lasting. Many people prefer dental implants to traditional dentures because they are more hardwearing and have a more realistic appearance. The artificial teeth which are used for overdentures come in a variety of forms. One of the main variations is related to cusps (the pointed end of the tooth). Cusped overdentures (also known as anatomic) are designed to imitate the natural tooth form, whereas cuspless overdentures (or non-anatomic) is essentially flat and designed to improve the function of chewing. The aim of this study is to compare the effects of cusped and cuspless implants on the health of the surrounding bone tissues in the mouth.
Who can participate?
Healthy adults over 40 with missing teeth for more than 3 years, who have refused removable partial dentures.
What does the study involve?
Participants are randomly allocated into two groups. Both groups have implants inserted after tooth extraction. The first group is given overdentures with cusped teeth, and the second group is given overdentures with cuspless teeth. Once the implants have been fitted, the healing process and how well they fit is measured at three, six, nine and twelve months. Participants are also asked to describe pain levels at these times.
What are the possible benefits and risks of participating?
Benefits of participating are that patients are treated using two advanced methods at no cost. There are no risks of participating.
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?
September 2013 to September 2014
Who is funding the study?
Albaha University (Saudi Arabia)
Who is the main contact?
1. Dr Hammdi Hakimi (Public)
yahio2000@yahoo.com
2. Professor Khalid Ahmad Omar Arafa (Scientific)
drkhalidarafa@yahoo.com
Trial website
Contact information
Type
Public
Primary contact
Dr Hammdi Hakimi
ORCID ID
http://orcid.org/0000-0002-3597-5073
Contact details
Al-Baha
Saudi Arabia
Al-Baha
00966
Saudi Arabia
+966 532 153553
yahio2000@yahoo.com
Type
Scientific
Additional contact
Prof Khalid Ahmad Omar Arafa
ORCID ID
http://orcid.org/0000-0002-3597-5073
Contact details
Dental Health Department
Faculty of Applied Medical Sciences
Albaha University
Albaha
65536
Saudi Arabia
+966 533 88866
drkhalidarafa@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The impact of immediate implant-supported mandibular overdentures with cusped and cuspless tooth on bone tissues
Acronym
Study hypothesis
The immediate implant-supported mandibular overdentures with cusped teeth is better than cuspless teeth.
Ethics approval
Dental Health Department of the Faculty of Applied Medical Sciences (Albaha University), 04/08/2013
Study design
A randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
This study aimed to examine the impact of immediate implant-supported mandibular overdentures with cusped or cuspless tooth on surrounding bone tissues.
Intervention
The randomization of selected patients was by lottery selection after giving each patient a number in a list, and then randomly the 20 patients were divided into two groups, 10 patients for each group.
Group 1: Rehabilitation with immediate implants (the implant inserted immediately after extraction) loaded with overdentures with cusped teeth.
Group 2: Rehabilitated with immediate implants (implants inserted immediately after extraction) loaded with overdentures with cuspless teeth.
Following flap elevation and the removal of a tooth and implant installation, inside the socket then the clinical measurements were made to characterize the dimension of the surrounding bone walls, as well as the marginal defect. There were no membranes or filler material was used. The flaps were subsequently replaced and secured with sutures in such a way that the healing cap of the implant was exposed to the oral environment. After 3 months of healing a re-entry procedure was performed and the clinical measurements were repeated.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Crestal bone loss observed over one year, at 3, 6, 9 and 12 months. The measurement of crestal bone loss by periapical radiographs was evaluated by the masial and distal marginal bone height around the abutments (implant) from the radiograph of each patient as follow; two points were marked one at apex of implant and anther at the tip of the implant, a line (A) was drown connecting the 2 points then the tangent (b) to the tip of tooth, marginal bone height was measured by a dial caliper from mesial and distal alveolar crest to line (b), and measurements on serial radiographs were compared and the results were statistically analyzed as mean and percent.
Secondary outcome measures
1. Periapical lesions measured in each cross-section from the widest and deepest part of the lesion by the researcher using a precision digital caliper with an accuracy of up to 0.01 mm, at 3, 6, 9 and 12 months.
2. Pain measured using visual analog scale (VAS) at 3, 6, 9 and 12 months
3. Neural sensibility measured using a pulp sensibility test, which includes an electric test, which extrapolates pulp health from sensory response, at 3, 6, 9 and 12 months
4. Mobility of implants measured according to the periotest, siemens dental bensheim, Germany at 3, 6, 9 and 12 months.
Overall trial start date
01/09/2013
Overall trial end date
12/09/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged over 40 years
2. Free from any systematic diseases
3. Non-smoker
4. Jaw relation angle class one
5. Refused removable partial dentures
6. Edentulous more than 3 years
7. Hopeless mandibular teeth
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
20 Edentoulus patients
Participant exclusion criteria
1. Diabetes
2. Hypertension
3. Patients who prefer the removable partial dentures
4. Immunodeficient patients
Recruitment start date
01/10/2013
Recruitment end date
01/09/2014
Locations
Countries of recruitment
Egypt
Trial participating centre
Al-Azhar University-Assiut Branch
Dental Clinic
Faculty of Dentistry
Assuit
71524
Egypt
Sponsor information
Organisation
Albaha University
Sponsor details
The faculty of Applied Medical Sciences
Prince Mohammad Bin Saud
N/A
00966
Saudi Arabia
+966 553 366688
drkhalidrafa@yahoo.com
Sponsor type
Not defined
Website
Funders
Funder type
Not defined
Funder name
Albaha University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intend to publish this study in ISI journals
Intention to publish date
01/10/2015
Participant level data
Available on request
Basic results (scientific)
Publication list
2016 results in https://www.ncbi.nlm.nih.gov/pubmed/26739979