Plain English Summary
Background and study aims
Translucent zirconia is a new dental material with high potential for dental prosthesis (false teeth); the research is comparing two different dental bridges designs made of translucent zirconia, in the matter of survival rate and clinical performance.
This research is important to develop a protocol for the treatment of missing teeth in specific conditions.
Who can participate?
Adults over 18 years who have lost the second premolar in one side or more.
What does the study involve?
Participants will be randomly allocated to receive either anatomic designed translucent zirconia bridges or traditional designed translucent zirconia bridges.
What are the possible benefits and risks of participating?
There will be no harms for the patients, and the new material has passed through multiple laboratory test before clinical trials.
Where is the study run from?
Damascus University - faculty of dental medicine (Syria)
When is the study starting and how long is it expected to run for?
March 2018 to October 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Shukri Alsamara, Shekrysamara89@gmail.com
The effect of the prosthesis design (monolithic, traditional) made of translucent zirconia on clinical performance: randomized controlled trial
There is significant difference in clinical performance between anatomic and traditional design.
Approved 24/01/2017, Ethical Committee of the Faculty of Dental Medicine (Damascus University, Damascus, Syria; +963 113341864; firstname.lastname@example.org), ref: 270/T.M
Interventional randomized control trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
No participant information sheet available
Patients who have lost one tooth or more and in need for dental prosthesis.
Patients have been divided randomly into two group:
Group A: received anatomic designed translucent zirconia bridges.
Group B: received traditional designed translucent zirconia bridges.
Follow up for two years.
Primary outcome measure
Measured using visual inspection at one month, 6 months, one year, two years:
1. Prothesis fracture: no fracture/color change or small fracture/zirconia fracture/complete fracture in the prosthesis
2. Marginal fit: complete fit/there is evidence of leakage/the probe can access the prothesis/prothesis is movable
3. Discoloration: no discoloration/surface discoloration/discoloration towards the pulb
Secondary outcome measures
Oral health index collected using oral examination and with UNC15 probe (university of North Carolina). Oral data collected from each patient on three different time intervals (after one month, after 6 months, after one year, after two years)
1. Plaque index (PI)
2. Gingival index (GI)
3. Decayed, missing, filled teeth index
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Lost second premolar in one side or more
2. Good oral hygiene
3. The pontics have good stability
4. Absence of oral dysfunction
Target number of participants
Participant exclusion criteria
The clinical crown length of the pontics is less than 3 mm
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Faculty of dental medicine Almazzah
Investigator initiated and funded
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.
Intention to publish date
Participant level data
To be made available at a later date
Basic results (scientific)