Problem With DenturesNCT05955989
Relining Assessment of Digital and Conventional Fabricated Complete Denture Base
A study testing soft lining of complete denture processed by 3 different techniques. in people with Problem With Dentures, run by Asmaa Nabil Elboraey at 1 site in Egypt.
Trial summary
The bond between the resilient denture liner material and the denture base is essential to improve complete denture accuracy and retention to the underlying ridge. The bonding characteristics between resilient denture reline materials and conventional Polymethyl methacrylate (PMMA) denture base polymers have been… Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Problem With Dentures
- What is being tested?
- soft lining of complete denture processed by 3 different techniques.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 Jan 2026
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients are free from any systemic diseases that might affect neuro-muscular control.
- Patients having class I maxilla-mandibular relationship
- Patients having healthy mucosa and normal salivary flow
Who cannot join
- Patients have severe bony undercut.
- Uncooperative patients.
- Patients having radiation to the head and neck region.
- Smoker patients.
Trial locations and contacts
1 site in 1 country.
About this study
The bond between the resilient denture liner material and the denture base is essential to improve complete denture accuracy and retention to the underlying ridge. The bonding characteristics between resilient denture reline materials and conventional Polymethyl methacrylate (PMMA) denture base polymers have been evaluated extensively. But with the introduction of digital fabricated complete denture, the bond characteristics between digitally fabricated dentures and denture liner is sparse.
Read the detailed description
Dental prostheses fabricated using different digital technology have become popular in recent years. Computer-aided design and computer-aided manufacturing (CAD-CAM) technology provides two techniques, milled or 3D printed technique which simplified the complex dental laboratory procedures by digitalizing the prosthetic design and automating the manufacturing process. Digitally fabricated prostheses have been reported to have excellent accuracy factor that has been related to favorable clinical performance. However, bone resorption underneath any mucosa supported prosthesis is not avoidable. Resilient liners are required for most complete dentures after 6 to 12 months to improve adaptation to the underlying tissues and to reduce the force transmitted to the edentulous ridge during functionThe bond between the resilient denture liner material and the denture base is essential to improve complete denture accuracy and retention to the underlying ridge. The bonding characteristics between resilient denture reline materials and conventional Polymethyl methacrylate (PMMA) denture base polymers have been evaluated extensively. But with the introduction of digital fabricated complete denture, the bond characteristics between digitally fabricated dentures and denture liner is sparse.
Therefore, the aim of this project is to evaluate the bond strength and effectiveness of denture reline of CAD/CAM (milled and 3D printed ) fabricated complete dentures compared to conventional heat-polymerized denture base.
- Conditions
- Problem With Dentures
- Being tested
- soft lining of complete denture processed by 3 different techniques.
- Keywords
- Relining, Milled denture, 3D-print, complete dentures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft lining of complete denture processed by 3 different techniques.Other
soft lining for complete denture
| Study group | Role | What they receive |
|---|---|---|
| Complete denture fabricated from Conventional heat curing | Active comparator | The patients in this group will receive complete dentures fabricated by conventional heat curing method. and they will receive soft lining of the complete dentures after one year. Receives: Other: soft lining of complete denture processed by 3 different techniques. |
| complete denture fabricated by CAD/CAM milled technology | Active comparator | The patients in this group will receive complete dentures fabricated by CAD/CAM ( Computer aided design/ Computer aided manufacture) method. and they will receive soft lining of the complete dentures after one year. Receives: Other: soft lining of complete denture processed by 3 different techniques. |
| complete denture fabricated by CAD/CAM 3D Printed technology | Active comparator | The patients in this group will receive complete dentures fabricated by 3D printing ( three dimension) method. and they will receive soft lining of the complete dentures after one year. Receives: Other: soft lining of complete denture processed by 3 different techniques. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change in retentive force of the complete denture
assessment of complete denture retention by digital force gauge
Measured: on 3rd month of denture insertion, on 6th month of denture insertion, on the 9th month of denture insertion
Assessment of change in occlusal forces during the follow up period.
Assessment of occlusion equilibrium by Occlusense device
Measured: on 3rd month of denture insertion, on 6th month of denture insertion, on the 9th month of denture insertion
Secondary outcomes (1)
Patient Satisfaction
a questionnaire was designed containing 5 questions regarding the following parameters: retention, comfort, appearance, phonetics and pain. Increasing the score meaning more patient satisfaction.
Measured: on day one of denture insertion and on the 9th month of denture insertion ( end of the follow up period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start1 May 2023
- Primary completion1 Jul 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem With DenturesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups of completely edentulous patients. Each group will receive complete denture processed with different technique. After one year the patients will recalled and relining of the denture were made to gain the retention. After one year assessment of retention by digital force gauge, occlusion equilibrium by T-Scan and patient satisfaction (PS)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asmaa Nabil Elboraey
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Centre, Egypt
- Responsible party
- Sponsor-investigator, Asmaa Nabil Elboraey, National Research Centre, Egypt
- Investigators
- Asmaa N. Elboraey, Asso, Prof, Principal investigator, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955989
- Sponsor's protocol ID
- 13060207
- Status last verified
- Apr 2023
- First submitted
- 10 Jul 2023
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relining Assessment of Digital and Conventional Fabricated Complete Denture Base
- ClinicalTrials.gov ID
- NCT05955989
- Acronym / sponsor ID
- 13060207
- Conditions
- Problem With Dentures
- Keywords
- Relining, Milled denture, 3D-print, complete dentures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Asmaa Nabil ElboraeyUniversity, hospital or other
- Collaborators
- National Research Centre, Egypt
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 21 Jul 2023 (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.
The bond between the resilient denture liner material and the denture base is essential to improve complete denture accuracy and retention to the underlying ridge. The bonding characteristics between resilient denture reline materials and conventional Polymethyl methacrylate (PMMA) denture base polymers have been evaluated extensively. But with the introduction of digital fabricated complete denture, the bond characteristics between digitally fabricated dentures and denture liner is sparse.
Detailed description
Dental prostheses fabricated using different digital technology have become popular in recent years. Computer-aided design and computer-aided manufacturing (CAD-CAM) technology provides two techniques, milled or 3D printed technique which simplified the complex dental laboratory procedures by digitalizing the prosthetic design and automating the manufacturing process. Digitally fabricated prostheses have been reported to have excellent accuracy factor that has been related to favorable clinical performance. However, bone resorption underneath any mucosa supported prosthesis is not avoidable. Resilient liners are required for most complete dentures after 6 to 12 months to improve adaptation to the underlying tissues and to reduce the force transmitted to the edentulous ridge during functionThe bond between the resilient denture liner material and the denture base is essential to improve complete denture accuracy and retention to the underlying ridge. The bonding characteristics between resilient denture reline materials and conventional Polymethyl methacrylate (PMMA) denture base polymers have been evaluated extensively. But with the introduction of digital fabricated complete denture, the bond characteristics between digitally fabricated dentures and denture liner is sparse.
Therefore, the aim of this project is to evaluate the bond strength and effectiveness of denture reline of CAD/CAM (milled and 3D printed ) fabricated complete dentures compared to conventional heat-polymerized denture base.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Three groups of completely edentulous patients. Each group will receive complete denture processed with different technique. After one year the patients will recalled and relining of the denture were made to gain the retention. After one year assessment of retention by digital force gauge, occlusion equilibrium by T-Scan and patient satisfaction (PS)
| Arm | Type | Receives |
|---|---|---|
| Complete denture fabricated from Conventional heat curing | Active comparator | Other: soft lining of complete denture processed by 3 different techniques.The patients in this group will receive complete dentures fabricated by conventional heat curing method. and they will receive soft lining of the complete dentures after one year. |
| complete denture fabricated by CAD/CAM milled technology | Active comparator | Other: soft lining of complete denture processed by 3 different techniques.The patients in this group will receive complete dentures fabricated by CAD/CAM ( Computer aided design/ Computer aided manufacture) method. and they will receive soft lining of the complete dentures after one year. |
| complete denture fabricated by CAD/CAM 3D Printed technology | Active comparator | Other: soft lining of complete denture processed by 3 different techniques.The patients in this group will receive complete dentures fabricated by 3D printing ( three dimension) method. and they will receive soft lining of the complete dentures after one year. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients are free from any systemic diseases that might affect neuro-muscular control.
- Patients having class I maxilla-mandibular relationship
- Patients having healthy mucosa and normal salivary flow
Key exclusion criteria (4 listed)
- Patients have severe bony undercut.
- Uncooperative patients.
- Patients having radiation to the head and neck region.
- Smoker patients.
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 |
|---|---|---|
| soft lining of complete denture processed by 3 different techniques.soft lining for complete denture | Other | Complete denture fabricated from Conventional heat curing, complete denture fabricated by CAD/CAM 3D Printed technology, complete denture fabricated by CAD/CAM milled technology |
Primary outcome
Assessment of change in retentive force of the complete denture
Time frame: on 3rd month of denture insertion, on 6th month of denture insertion, on the 9th month of denture insertion
assessment of complete denture retention by digital force gauge
Assessment of change in occlusal forces during the follow up period.
Time frame: on 3rd month of denture insertion, on 6th month of denture insertion, on the 9th month of denture insertion
Assessment of occlusion equilibrium by Occlusense device
1 secondary outcome
Patient Satisfaction
Time frame: on day one of denture insertion and on the 9th month of denture insertion ( end of the follow up period)
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 2 Jun 2026.
- 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.
Asmaa N. Elboraey, Asso, Prof principal investigator
National Research Centre, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soft lining of complete denture processed by 3 different techniques. in people with Problem With Dentures, run by Asmaa Nabil Elboraey 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 3 inclusion and 4 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 2 Jun 2026. 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?
Assessment of change in retentive force of the complete denture (time frame: on 3rd month of denture insertion, on 6th month of denture insertion, on the 9th month of denture insertion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.