Diabetes Free Completely Edentulous PatientsNCT03226990
Detection of Pressure Areas for Two Elastomeric Impressions
A study testing impression technique in people with Diabetes Free Completely Edentulous Patients, run by Cairo University at 1 site in Egypt.
Trial summary
Forty completely edentulous patients were selected and randomly distributed into two groups 20 patients each.Group I received complete dentures constructed from elastomeric impression with wax spacer,group II received complete dentures constructed from elastomeric impression with no wax spacer.then on time of denture… Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Diabetes Free Completely Edentulous Patients
- What is being tested?
- impression technique
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2017to 1 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- completely edentulous upper and lower arches. well to moderately developed ridges saliva of average viscosity and amount with normal temporomandibular joint
Who cannot join
- diabetic patients radiation therapy signs of inflammation, ulceration or hyperplasia neurological disorders clicking or mandibular deviation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Pressure Areas for Elastomeric Impressions With and Without Spacer Using Novel Digital Analyzing Software and Its Correlation With Retention.A Randomized Clinical Trial.
Forty completely edentulous patients were selected and randomly distributed into two groups 20 patients each.Group I received complete dentures constructed from elastomeric impression with wax spacer,group II received complete dentures constructed from elastomeric impression with no wax spacer.then on time of denture insertion pressure areas were detected using pressure indicating paste and the denture retention was detected.The results showed less pressure areas in group I and more denture retention values than group II.
Read the detailed description
This study was conducted to evaluate the significance of using wax spacer in the impression technique regarding the pressure areas and retention of the complete dentures constructed. Forty patients with edentulous maxillary arches were selected from the outpatient clinic of removable prosthodontics department, faculty of oral and dental medicine, Cairo university .The patients were randomly divided into two groups. Group I received dentures constructed from impression technique with wax spacer while group II received dentures constructed from impression technique with no spacer. On the day of denture insertion pressure areas were detected using pressure indicating paste and denture retention was measured using force gauge. The data was collected and analyzed using student's t-test.
- Being tested
- impression technique
- Keywords
- pressure area, polyether elastomeric impression, wax spacer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
impression techniqueOther
impression technique with and without wax spacer
What is being measured
The primary outcome is the main question the study is designed to answer.
pressure areas
pressure indicating paste on the fitting surface ,then the surface was captured then saved as JPEG format then Analysis was done using Image J software
Measured: 1month
Secondary outcomes (1)
denture retention
using force gauge to give retentive values in Newtons
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Jun 2017
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Free Completely Edentulous PatientsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The measurements are done on the day of denture insertion with no follow up timing intervals
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nancy nader elsherbini, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226990
- Sponsor's protocol ID
- prosthesis87-2017
- Status last verified
- Jul 2017
- First submitted
- 17 Jul 2017
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Masri R, Driscoll CF, Burkhardt J, Von Fraunhofer A, Romberg E. Pressure generated on a simulated oral analog by impression materials in custom trays of different designs. J Prosthodont. 2002 Sep;11(3):155-60.
PubMed 12237795Wang CW, Shao Q, Sun HQ, Mao MY, Zhang XW, Gong Q, Xiao GN. Influence of inner circular sealing area impression method on the retention of complete dentures. Braz Dent J. 2015 Mar-Apr;26(2):198-202. doi: 10.1590/0103-6440201300383. Epub 2015 Apr 1.
PubMed 25831114Al-Ahmar AO, Lynch CD, Locke M, Youngson CC. Quality of master impressions and related materials for fabrication of complete dentures in the UK. J Oral Rehabil. 2008 Feb;35(2):111-5. doi: 10.1111/j.1365-2842.2007.01796.x. Epub 2007 Dec 5.
PubMed 18053059
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Pressure Areas for Elastomeric Impressions With and Without Spacer Using Novel Digital Analyzing Software and Its Correlation With Retention.A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03226990
- Acronym / sponsor ID
- prosthesis87-2017
- Keywords
- pressure area, polyether elastomeric impression, wax spacer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Forty completely edentulous patients were selected and randomly distributed into two groups 20 patients each.Group I received complete dentures constructed from elastomeric impression with wax spacer,group II received complete dentures constructed from elastomeric impression with no wax spacer.then on time of denture insertion pressure areas were detected using pressure indicating paste and the denture retention was detected.The results showed less pressure areas in group I and more denture retention values than group II.
Detailed description
This study was conducted to evaluate the significance of using wax spacer in the impression technique regarding the pressure areas and retention of the complete dentures constructed. Forty patients with edentulous maxillary arches were selected from the outpatient clinic of removable prosthodontics department, faculty of oral and dental medicine, Cairo university .The patients were randomly divided into two groups. Group I received dentures constructed from impression technique with wax spacer while group II received dentures constructed from impression technique with no spacer. On the day of denture insertion pressure areas were detected using pressure indicating paste and denture retention was measured using force gauge. The data was collected and analyzed using student's t-test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Model description
- The measurements are done on the day of denture insertion with no follow up timing intervals
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- completely edentulous upper and lower arches. well to moderately developed ridges saliva of average viscosity and amount with normal temporomandibular joint
Key exclusion criteria (1 listed)
- diabetic patients radiation therapy signs of inflammation, ulceration or hyperplasia neurological disorders clicking or mandibular deviation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| impression techniqueimpression technique with and without wax spacer | Other | – |
Primary outcome
pressure areas
Time frame: 1month
pressure indicating paste on the fitting surface ,then the surface was captured then saved as JPEG format then Analysis was done using Image J software
1 secondary outcome
denture retention
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Background: PubMed 12237795Masri R, Driscoll CF, Burkhardt J, Von Fraunhofer A, Romberg E. Pressure generated on a simulated oral analog by impression materials in custom trays of different designs. J Prosthodont. 2002 Sep;11(3):155-60.
- Background: PubMed 25831114Wang CW, Shao Q, Sun HQ, Mao MY, Zhang XW, Gong Q, Xiao GN. Influence of inner circular sealing area impression method on the retention of complete dentures. Braz Dent J. 2015 Mar-Apr;26(2):198-202. doi: 10.1590/0103-6440201300383. Epub 2015 Apr 1.
- Background: PubMed 18053059Al-Ahmar AO, Lynch CD, Locke M, Youngson CC. Quality of master impressions and related materials for fabrication of complete dentures in the UK. J Oral Rehabil. 2008 Feb;35(2):111-5. doi: 10.1111/j.1365-2842.2007.01796.x. Epub 2007 Dec 5.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing impression technique in people with Diabetes Free Completely Edentulous Patients, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pressure areas (time frame: 1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03226990, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.