Complete EdentulismNCT07911371
Comparison of 3D-Printed and Heat-Cured Upper Complete Denture Bases
A study testing Heat-Polymerised Maxillary Complete Denture Base and 3D-Printed Maxillary Complete Denture Base in people with Complete Edentulism, run by Arab International University at 1 site in Syria.
Trial summary
This study compared two methods of making bases for upper complete dentures: three-dimensional (3D) printing and conventional heat curing. A denture base rests on the gums and supports the artificial teeth. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- Heat-Polymerised Maxillary Complete Denture Base and 3D-Printed Maxillary Complete Denture Base
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSyria
- Study dates
- 16 Mar 2024to 15 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Complete maxillary edentulism for at least six months following tooth extraction.
- Requirement for a maxillary complete denture.
- A well-healed, smooth, rounded, U-shaped residual ridge corresponding to Cawood and Howell class III.
- Healthy supporting mucosa without signs of inflammation.
- Normal salivary flow.
Who cannot join
- Inflamed or irritated supporting mucosa.
- Severe residual ridge resorption corresponding to Cawood and Howell class V or VI.
- Bony undercuts.
- Smoking.
- History of radiotherapy to the head and neck region.
- Inability to cooperate with the clinical procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retention, Stability and Support of 3D-Printed Versus Heat-Polymerised Maxillary Complete Denture Bases: A Within-Participant Clinical Study
This study compared two methods of making bases for upper complete dentures: three-dimensional (3D) printing and conventional heat curing. A denture base rests on the gums and supports the artificial teeth. The aim was to determine whether the manufacturing method affected retention, stability and support: how well the base resisted being dislodged, resisted horizontal or rocking movements, and resisted movement towards the supporting tissues under pressure.
Sixteen participants with no remaining upper teeth took part. Two denture bases were made for each participant from the same dental impression, one using each manufacturing method. The order in which the bases were tested was randomly determined by computer. The bases were labelled with codes so that two independent examiners were not informed of the manufacturing method. Each examiner assessed anterior and posterior retention, front-to-back and lateral stability, and front-to-back and lateral support using predefined rating scales. Scores were compared within each participant, and agreement between the examiners was also evaluated.
Read the detailed description
This study compared the retention, stability and support of 3D-printed and heat-polymerised maxillary complete denture bases in 16 participants. Eligible participants had been completely edentulous in the maxilla for at least six months and had well-healed residual ridges, healthy supporting mucosa and normal salivary flow.
Two bases were fabricated for each participant from the same definitive impression. The conventional base was produced by heat polymerisation on the master cast. The printed base was digitally designed from a scan of the cast, printed from photopolymer resin, washed and post-cured. Both bases had a nominal thickness of 3 mm and incorporated testing handles.
Assessment order was computer-randomised. Two independent prosthodontists evaluated coded bases without being informed of the fabrication technique. After 30 seconds of intraoral seating, each base was assessed for anterior and posterior retention, anteroposterior and lateral stability, and anteroposterior and lateral support. Retention and stability were rated on four-point scales and support on a three-point scale, with higher scores indicating better performance.
Between-technique comparisons used the mean examiner ratings and paired Wilcoxon signed-rank tests with Holm adjustment. Inter-examiner agreement was evaluated using exact percentage agreement and linearly weighted Gwet's AC2.
- Conditions
- Complete Edentulism
- Being tested
- Heat-Polymerised Maxillary Complete Denture Base, 3D-Printed Maxillary Complete Denture Base
- Keywords
- Complete dentures, maxillary denture bases, heat polymerisation, three-dimensional printing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat-Polymerised Maxillary Complete Denture BaseDevice
A maxillary acrylic denture base fabricated directly on the master cast using conventional flasking and resin packing. The base had a nominal thickness of 3 mm and incorporated three testing handles. Processing involved a water bath at 73°C for two hours.
3D-Printed Maxillary Complete Denture BaseDevice
A maxillary denture base digitally designed from a laboratory scan of the master cast and fabricated from photopolymer resin using LCD-based stereolithography. The base had a nominal thickness of 3 mm and incorporated three testing handles. Printing was followed by alcohol washing and additional light polymerisation.
| Study group | Role | What they receive |
|---|---|---|
| 3D-Printed Followed by Heat-Polymerised Denture Base | Experimental | Participants underwent clinical assessment with the 3D-printed maxillary denture base first, followed by the heat-polymerised base. Both bases were fabricated from the same definitive impression. Two masked examiners independently assessed retention, stability and support for each base. Receives: Device: Heat-Polymerised Maxillary Complete Denture Base; Device: 3D-Printed Maxillary Complete Denture Base |
| Heat-Polymerised Followed by 3D-Printed Denture Base | Experimental | Participants underwent clinical assessment with the heat-polymerised maxillary denture base first, followed by the 3D-printed base. Both bases were fabricated from the same definitive impression. Two masked examiners independently assessed retention, stability and support for each base. Receives: Device: Heat-Polymerised Maxillary Complete Denture Base; Device: 3D-Printed Maxillary Complete Denture Base |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Retention of the Maxillary Denture Base
Anterior retention was independently rated by two masked examiners on a four-point scale: 1 = no retention with spontaneous displacement; 2 = poor retention with minimal resistance to dislodgement; 3 = moderate retention; and 4 = good retention with maximal resistance to dislodgement. Higher scores indicated better retention. The mean of both examiners' scores was used for comparison between fabrication techniques.
Measured: At the clinical assessment of each denture base, following 30 seconds of intraoral seating.
Posterior Retention of the Maxillary Denture Base
Posterior retention was independently rated by two masked examiners on a four-point scale: 1 = no retention with spontaneous displacement; 2 = poor retention with minimal resistance to dislodgement; 3 = moderate retention; and 4 = good retention with maximal resistance to dislodgement. Higher scores indicated better retention. The mean of both examiners' scores was used for comparison between fabrication techniques.
Measured: At the clinical assessment of each denture base, following 30 seconds of intraoral seating.
Secondary outcomes (4)
Anteroposterior Stability of the Maxillary Denture Base
Two masked examiners independently assessed anteroposterior stability using a four-point scale: 1 = displacement under light force; 2 = displacement under moderate force; 3 = displacement only under strong force; and 4 = stability maintained under strong force. Higher scores indicated better stability. The mean of the two examiners' ratings was used for comparison.
Measured: At the clinical assessment of each denture base, following 30 seconds of intraoral seating.
Lateral Stability of the Maxillary Denture Base
Two masked examiners independently assessed lateral stability using a four-point scale: 1 = displacement under light force; 2 = displacement under moderate force; 3 = displacement only under strong force; and 4 = stability maintained under strong force. Higher scores indicated better stability. The mean of the two examiners' ratings was used for comparison.
Measured: At the clinical assessment of each denture base, following 30 seconds of intraoral seating.
Anteroposterior Support of the Maxillary Denture Base
Two masked examiners independently assessed anteroposterior support under pressure directed towards the supporting tissues. A three-point scale was used: 1 = pronounced rocking; 2 = moderate rocking; and 3 = no or minimal rocking. Higher scores indicated better support. The mean of the two examiners' ratings was used for comparison.
Measured: At the clinical assessment of each denture base, following 30 seconds of intraoral seating.
Lateral Support of the Maxillary Denture Base
Two masked examiners independently assessed lateral support under pressure directed towards the supporting tissues. A three-point scale was used: 1 = pronounced rocking; 2 = moderate rocking; and 3 = no or minimal rocking. Higher scores indicated better support. The mean of the two examiners' ratings was used for comparison.
Measured: At the clinical assessment of each denture base, following 30 seconds of intraoral seating.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start16 Mar 2024
- Primary completion20 Nov 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Complete EdentulismStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arab International University
- Sponsor type
- University, hospital or other
- Collaborators
- Damascus University
- Responsible party
- Sponsor
- Investigators
- Mohammad Murhaf Habash, DDs, Principal investigator, Damascus UniversityAmmar Almustafa, PhD, Study chair, Damascus UniversitySaleh Al Kurdi, PhD, Study director, Arab International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911371
- Sponsor's protocol ID
- DN-05042023-517
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Faty MA, Sabet ME, Thabet YG. A Comparison of Denture Base Retention and Adaptation Between CAD/CAM and Conventional Fabrication Techniques. Int J Prosthodont. 2023 Sep 12;36(4):469-478. doi: 10.11607/ijp.7193.
PubMed 37699188Maniewicz S, Imamura Y, El Osta N, Srinivasan M, Muller F, Chebib N. Fit and retention of complete denture bases: Part I - Conventional versus CAD-CAM methods: A clinical controlled crossover study. J Prosthet Dent. 2024 Apr;131(4):611-617. doi: 10.1016/j.prosdent.2022.07.006. Epub 2022 Sep 15.
PubMed 36116950Emera RMK, Shady M, Alnajih MA. Comparison of retention and denture base adaptation between conventional and 3D-printed complete dentures. J Dent Res Dent Clin Dent Prospects. 2022 Summer;16(3):179-185. doi: 10.34172/joddd.2022.030. Epub 2022 Nov 15.
PubMed 36704186Tosun ON, Bilmenoglu C, Ozdemir AK. Comparison of denture base adaptation between additive and conventional fabrication techniques. J Prosthodont. 2023 Mar;32(3):e64-e70. doi: 10.1111/jopr.13623. Epub 2023 Jan 2.
PubMed 36495146Helal MA, Ali Abd El Rahman IM, Atito E, Bahaa El-Din SM, Fayad M. Evaluation of Retention and Oral Health-Related Quality of Life for Completely Edentulous Subjects Wearing Heat-Cured, 3D-Printed, and Injection-Molded Polyamide Complete Dentures: Randomized Crossover Clinical Trial. Dent J (Basel). 2026 Feb 6;14(2):95. doi: 10.3390/dj14020095.
PubMed 41744932
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention, Stability and Support of 3D-Printed Versus Heat-Polymerised Maxillary Complete Denture Bases: A Within-Participant Clinical Study
- ClinicalTrials.gov ID
- NCT07911371
- Acronym / sponsor ID
- DN-05042023-517
- Conditions
- Complete Edentulism
- Keywords
- Complete dentures, maxillary denture bases, heat polymerisation, three-dimensional printing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Arab International UniversityUniversity, hospital or other
- Collaborators
- Damascus University
- Study start
- 16 Mar 2024 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 2 Nov 2026 (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.
This study compared two methods of making bases for upper complete dentures: three-dimensional (3D) printing and conventional heat curing. A denture base rests on the gums and supports the artificial teeth. The aim was to determine whether the manufacturing method affected retention, stability and support: how well the base resisted being dislodged, resisted horizontal or rocking movements, and resisted movement towards the supporting tissues under pressure.
Sixteen participants with no remaining upper teeth took part. Two denture bases were made for each participant from the same dental impression, one using each manufacturing method. The order in which the bases were tested was randomly determined by computer. The bases were labelled with codes so that two independent examiners were not informed of the manufacturing method. Each examiner assessed anterior and posterior retention, front-to-back and lateral stability, and front-to-back and lateral support using predefined rating scales. Scores were compared within each participant, and agreement between the examiners was also evaluated.
Detailed description
This study compared the retention, stability and support of 3D-printed and heat-polymerised maxillary complete denture bases in 16 participants. Eligible participants had been completely edentulous in the maxilla for at least six months and had well-healed residual ridges, healthy supporting mucosa and normal salivary flow.
Two bases were fabricated for each participant from the same definitive impression. The conventional base was produced by heat polymerisation on the master cast. The printed base was digitally designed from a scan of the cast, printed from photopolymer resin, washed and post-cured. Both bases had a nominal thickness of 3 mm and incorporated testing handles.
Assessment order was computer-randomised. Two independent prosthodontists evaluated coded bases without being informed of the fabrication technique. After 30 seconds of intraoral seating, each base was assessed for anterior and posterior retention, anteroposterior and lateral stability, and anteroposterior and lateral support. Retention and stability were rated on four-point scales and support on a three-point scale, with higher scores indicating better performance.
Between-technique comparisons used the mean examiner ratings and paired Wilcoxon signed-rank tests with Holm adjustment. Inter-examiner agreement was evaluated using exact percentage agreement and linearly weighted Gwet's AC2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D-Printed Followed by Heat-Polymerised Denture Base | Experimental | Device: Heat-Polymerised Maxillary Complete Denture Base, Device: 3D-Printed Maxillary Complete Denture BaseParticipants underwent clinical assessment with the 3D-printed maxillary denture base first, followed by the heat-polymerised base. Both bases were fabricated from the same definitive impression. Two masked examiners independently assessed retention, stability and support for each base. |
| Heat-Polymerised Followed by 3D-Printed Denture Base | Experimental | Device: Heat-Polymerised Maxillary Complete Denture Base, Device: 3D-Printed Maxillary Complete Denture BaseParticipants underwent clinical assessment with the heat-polymerised maxillary denture base first, followed by the 3D-printed base. Both bases were fabricated from the same definitive impression. Two masked examiners independently assessed retention, stability and support for each base. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Complete maxillary edentulism for at least six months following tooth extraction.
- Requirement for a maxillary complete denture.
- A well-healed, smooth, rounded, U-shaped residual ridge corresponding to Cawood and Howell class III.
- Healthy supporting mucosa without signs of inflammation.
- Normal salivary flow.
Key exclusion criteria (6 listed)
- Inflamed or irritated supporting mucosa.
- Severe residual ridge resorption corresponding to Cawood and Howell class V or VI.
- Bony undercuts.
- Smoking.
- History of radiotherapy to the head and neck region.
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 |
|---|---|---|
| Heat-Polymerised Maxillary Complete Denture BaseA maxillary acrylic denture base fabricated directly on the master cast using conventional flasking and resin packing. The base had a nominal thickness of 3 mm and incorporated three testing handles. Processing involved a water bath at 73°C for two hours. | Device | 3D-Printed Followed by Heat-Polymerised Denture Base, Heat-Polymerised Followed by 3D-Printed Denture Base |
| 3D-Printed Maxillary Complete Denture BaseA maxillary denture base digitally designed from a laboratory scan of the master cast and fabricated from photopolymer resin using LCD-based stereolithography. The base had a nominal thickness of 3 mm and incorporated three testing handles. Printing was followed by alcohol washing and additional light polymerisation. | Device | 3D-Printed Followed by Heat-Polymerised Denture Base, Heat-Polymerised Followed by 3D-Printed Denture Base |
Primary outcome
Anterior Retention of the Maxillary Denture Base
Time frame: At the clinical assessment of each denture base, following 30 seconds of intraoral seating.
Anterior retention was independently rated by two masked examiners on a four-point scale: 1 = no retention with spontaneous displacement; 2 = poor retention with minimal resistance to dislodgement; 3 = moderate retention; and 4 = good retention with maximal resistance to dislodgement. Higher scores indicated better retention. The mean of both examiners' scores was used for comparison between fabrication techniques.
Posterior Retention of the Maxillary Denture Base
Time frame: At the clinical assessment of each denture base, following 30 seconds of intraoral seating.
Posterior retention was independently rated by two masked examiners on a four-point scale: 1 = no retention with spontaneous displacement; 2 = poor retention with minimal resistance to dislodgement; 3 = moderate retention; and 4 = good retention with maximal resistance to dislodgement. Higher scores indicated better retention. The mean of both examiners' scores was used for comparison between fabrication techniques.
4 secondary outcomes
Anteroposterior Stability of the Maxillary Denture Base
Time frame: At the clinical assessment of each denture base, following 30 seconds of intraoral seating.
Lateral Stability of the Maxillary Denture Base
Time frame: At the clinical assessment of each denture base, following 30 seconds of intraoral seating.
Anteroposterior Support of the Maxillary Denture Base
Time frame: At the clinical assessment of each denture base, following 30 seconds of intraoral seating.
Lateral Support of the Maxillary Denture Base
Time frame: At the clinical assessment of each denture base, following 30 seconds of intraoral seating.
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 Nov 2026.
- Background: PubMed 37699188Faty MA, Sabet ME, Thabet YG. A Comparison of Denture Base Retention and Adaptation Between CAD/CAM and Conventional Fabrication Techniques. Int J Prosthodont. 2023 Sep 12;36(4):469-478. doi: 10.11607/ijp.7193.
- Background: PubMed 36116950Maniewicz S, Imamura Y, El Osta N, Srinivasan M, Muller F, Chebib N. Fit and retention of complete denture bases: Part I - Conventional versus CAD-CAM methods: A clinical controlled crossover study. J Prosthet Dent. 2024 Apr;131(4):611-617. doi: 10.1016/j.prosdent.2022.07.006. Epub 2022 Sep 15.
- Background: PubMed 36704186Emera RMK, Shady M, Alnajih MA. Comparison of retention and denture base adaptation between conventional and 3D-printed complete dentures. J Dent Res Dent Clin Dent Prospects. 2022 Summer;16(3):179-185. doi: 10.34172/joddd.2022.030. Epub 2022 Nov 15.
- Background: PubMed 36495146Tosun ON, Bilmenoglu C, Ozdemir AK. Comparison of denture base adaptation between additive and conventional fabrication techniques. J Prosthodont. 2023 Mar;32(3):e64-e70. doi: 10.1111/jopr.13623. Epub 2023 Jan 2.
- Background: PubMed 41744932Helal MA, Ali Abd El Rahman IM, Atito E, Bahaa El-Din SM, Fayad M. Evaluation of Retention and Oral Health-Related Quality of Life for Completely Edentulous Subjects Wearing Heat-Cured, 3D-Printed, and Injection-Molded Polyamide Complete Dentures: Randomized Crossover Clinical Trial. Dent J (Basel). 2026 Feb 6;14(2):95. doi: 10.3390/dj14020095.
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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.
Mohammad Murhaf Habash, DDs principal investigator
Damascus University
Ammar Almustafa, PhD study chair
Damascus University
Saleh Al Kurdi, PhD study director
Arab International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat-Polymerised Maxillary Complete Denture Base and 3D-Printed Maxillary Complete Denture Base in people with Complete Edentulism, run by Arab International University at 1 site in Syria.
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 5 inclusion and 6 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 Nov 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 Syria. 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?
Anterior Retention of the Maxillary Denture Base (time frame: At the clinical assessment of each denture base, following 30 seconds of intraoral seating.). 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?
On the ClinicalTrials.gov record for NCT07911371, which also lists 5 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 2 Nov 2026.