Retention of complete dentures made from traditional and digital impressions
| ISRCTN | ISRCTN66836054 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66836054 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Damascus University |
| Funder | Investigator initiated and funded |
- Submission date
- 21/07/2025
- Registration date
- 19/08/2025
- Last edited
- 19/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study aims to assess whether intra-oral scanners can provide a good fit and retention for complete dentures when used for final impression taking.
Who can participate?
Patients who have had missing upper teeth for more than 6 months
What does the study involve?
Participants underwent two types of impressions: conventional impressions involved using custom trays with impression compound and zinc oxide eugenol, and digital impressions using an intra-oral scanner. The conventional impressions were digitised using a laboratory scanner and then both impressions were compared. Two complete denture bases were printed out of both impressions and were assessed by two specialists.
Where is the study run from?
Faculty of Dentistry, Damascus University (Syria)
When is the study starting and how long is it expected to run for?
January 2024 to June 2025
Who is funding the study?
The study is self-funded as part of a postgraduate academic project and is supported by Damascus University (Syria)
Who is the main contact?
Dr Mohammad Murhaf Habash, morhaf.habash@damascusuniversity.edu.sy, morhafmbn@gmail.com
Contact information
Public, Scientific, Principal investigator
Faculty of Dentistry
Damascus University
Damascus
-
Syria
 ORCID ID |
0009-0001-6006-9806 |
|---|---|
| Phone | +963 (0)957814981 |
| morhaf.habash@damascusuniversity.edu.sy |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre interventional double-blinded non-randomized controlled trial |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Fit and retention of complete denture bases fabricated from conventional and digital impressions, modified in the post dam. A comparative in-vivo study |
| Study objectives | The use of intra-oral scanner for taking complete denture's impressions has comparable results of adaption and retention as using conventional impressions |
| Ethics approval(s) | Ethics approval not required |
| Health condition(s) or problem(s) studied | Fit and retention of complete denture bases |
| Intervention | This is a single-centre interventional non-randomised clinical study conducted to assess the effect of intra-oral scanners on the fit and retention of complete denture bases. The intervention involves using the intra-oral scanner to take a final impression of edentulous arches for complete denture fabrication and then printing denture bases. The control group involves taking zinc oxide eugenol impressions of the same edentulous patient. The differences between the control group and the test group will be measured by overlapping both impressions using Geomagic Control X. Retention will be assessed by two specialists after printing denture bases from both impressions. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Fit of complete denture bases measured by both conventional and digital impressions will undergo a 3D analysis after converting them to STL files to determine how close the digital impression is to the conventional impression, considering the conventional one as a reference while creating a colour map to showcase the difference, immediately after taking both impressions via Geomagic X. |
| Key secondary outcome measure(s) |
Retention of complete denture bases. Two resin bases will be printed from both impressions, then assessed by two specialists at the department of removable prosthodontics in Damascus University after printing the resin complete denture bases. |
| Completion date | 17/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 20 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Edentulous patients in the maxillary region for no less than 6 months 2. Residual ridges are rounded and U-shaped 3. No signs of inflammation on the mucosa and soft tissues |
| Key exclusion criteria | 1. Severe absorption of the residual ridges 2. Flabby tissues 3. Non collaborative patients |
| Date of first enrolment | 25/03/2024 |
| Date of final enrolment | 15/02/2025 |
Locations
Countries of recruitment
- Syria
Study participating centre
Mazzeh Highway
Damascus
-
Syria
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Available upon request from morhafmbn@gmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/08/2025: Study's existence confirmed by Damascus University.
