Comparing two different dental bridge designs made of translucent zirconia
| ISRCTN | ISRCTN12231125 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12231125 |
| Secondary identifying numbers | 217/T.M |
- Submission date
- 02/05/2020
- Registration date
- 05/05/2020
- Last edited
- 05/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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
Contact information
Scientific
Damascus university - faculty of dental medicine
Almazzah highway
Damascus
-
Syria
 ORCID ID |
0000-0002-1046-1754 |
|---|---|
| Phone | +963 991 982 422 |
| Shekrysamara89@gmail.com |
Study information
| Study design | Interventional randomized control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | The effect of the prosthesis design (monolithic, traditional) made of translucent zirconia on clinical performance: randomized controlled trial |
| Study objectives | There is significant difference in clinical performance between anatomic and traditional design. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 24/01/2017 |
| Completion date | 01/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Key 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 |
| Key exclusion criteria | The clinical crown length of the pontics is less than 3 mm |
| Date of first enrolment | 01/03/2018 |
| Date of final enrolment | 01/10/2019 |
Locations
Countries of recruitment
- Syria
Study participating centre
Almazzah
Damascus
-
Syria
Sponsor information
University/education
Almazzah
Damascus
-
Syria
| Phone | +963 11 334 1864 |
|---|---|
| manager@hcsr.gov.sy | |
| Website | http://damasuniv.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/11/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Editorial Notes
05/05/2020: Trial’s existence confirmed by Ethical Committee of the Faculty of Dental Medicine, Damascus University.
