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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Shukri Alsamara
ORCID ID
https://orcid.org/0000-0002-1046-1754
Contact details
Damascus university - faculty of dental medicine
Almazzah highway
Damascus
-
Syria
+963 991 982 422
Shekrysamara89@gmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
217/T.M
Study information
Scientific title
The effect of the prosthesis design (monolithic, traditional) made of translucent zirconia on clinical performance: randomized controlled trial
Acronym
Study hypothesis
There is significant difference in clinical performance between anatomic and traditional design.
Ethics approval
Approved 24/01/2017, Ethical Committee of the Faculty of Dental Medicine (Damascus University, Damascus, Syria; +963 113341864; manager@hcsr.gov.sy), ref: 270/T.M
Study design
Interventional randomized control trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Patients who have lost one tooth or more and in need for dental prosthesis.
Intervention
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.
Intervention type
Other
Phase
Drug names
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
24/01/2017
Overall trial end date
01/10/2020
Reason abandoned (if study stopped)
Eligibility
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
The clinical crown length of the pontics is less than 3 mm
Recruitment start date
01/03/2018
Recruitment end date
01/10/2019
Locations
Countries of recruitment
Syria
Trial participating centre
Damascus university
Faculty of dental medicine
Almazzah
Damascus
-
Syria
Sponsor information
Organisation
Damascus University
Sponsor details
Almazzah
Damascus
-
Syria
+963 11 334 1864
manager@hcsr.gov.sy
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
01/11/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list