Condition category
Oral Health
Date applied
02/05/2020
Date assigned
05/05/2020
Last edited
05/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

http://damasuniv.edu.sy/

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

Publication citations

Additional files

Editorial Notes

05/05/2020: Trial’s existence confirmed by Ethical Committee of the Faculty of Dental Medicine, Damascus University.