Swallowing DisorderNCT07290933
Oral Food Processing for Digitally Constructed Complete Dentures Versus Conventional Complete Dentures.
A study testing Procedure for construction of complete denture either conventional or fully digital fabrication in people with Swallowing Disorder, run by Mansoura University at 1 site in Egypt.
Trial summary
The study aimed to compare the effects of fully digital versus conventional complete denture fabrication on oral food processing (mastication and swallowing of solids) in edentulous patients, using the Test of Mastication and Swallowing Solids (TOMASS). Read more about this study
- Who is it for?
- Ages 50 to 66 years
- Conditions the study is for
- Swallowing Disorder
- What is being tested?
- Procedure for construction of complete denture either conventional or fully digital fabrication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Nov 2024to 2 Dec 2025
- 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 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Participants with temporo-mandibular joint disorders.
- head/neck injury, or with skeletal deformity.
- Inability to wear dentures for extended periods or intolerance to the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Removable prosthodontics department,Faculty of dentistry,Mansoura university, #68 ElGomhoria Street, ElMansoura, Egypt. Mansoura, Eldakahlia, Egypt, 35516
Al Mansurah, Eldakahlia,, 35516
About this study
Official title: Oral Food Processing for Digitally Constructed Complete Dentures Versus Conventional Complete Dentures: A Randomized Crossover Study
The study aimed to compare the effects of fully digital versus conventional complete denture fabrication on oral food processing (mastication and swallowing of solids) in edentulous patients, using the Test of Mastication and Swallowing Solids (TOMASS).
In a randomized crossover study design was carried out on 14 completely edentulous participants (age 50-65 years, both sexes) in good general and oral health, each participants received two sets of dentures: one fabricated with conventional workflow (physical impressions, tooth arrangement, processing into heat polymerized acrylic) and one fully digital workflow (Intra-oral scanning , CAD/CAM design, 3D printed base and teeth,). Each denture was worn for 3 months; with a 2 week "wash out" period between wearing periods, during which participants reverted to their old dentures or no dentures. The order (Conventional complete denture first vs Digital complete denture first) was randomized. At the end of each denture period, Oral food processing performance was measured using TOMASS (solid cracker test): Swallowing threshold and TOMASS test parameters that include number of bites, number of masticatory cycles, number of swallows, and total time (from first bite to last swallow)
Read the detailed description
Fourteen completely edentulous patients were participated in this study, their ages range from 50- 70 years. The participants were selected from Prosthodontics Department, Faculty of Dentistry, Mansoura University who are seeking for complete denture treatment. All participants will be completely edentulous for at least 6 months and have no previous experience with removable prosthesis. Subjects with temporomandibular joint disorders, head/neck injury, or with skeletal deformity were excluded from this study. All participants were Angel's class I maxillomandibular relation. Informed consent were written from each patient, and approval from the Faculty Ethical Committee will be obtained. The sample size was deter¬mined based on the number of chews for TOMASS test data from previous research. A computer software program (G*power, version 3.1.5, Kiel, Germany) was used for sample size calculation. 14 participants was detected with an effect size of 72%, 5% error probability, and 80% power.
Complete dentures construction:
At the first visit Direct intraoral scanning of both arches were performed with an intraoral scanner (TRIOS 3; 3Shape A/S). Cheek retractors were used to gently extend the movable soft tissues. The ridge crest were scanned first, followed by scans of the labial or buccal and palatal or lingual surfaces of the ridge. For the maxillary arch, the palate were additionally scanned. After establishing the overall contour in this manner, the remaining unscanned parts were scanned to finalize the complete arch scan. Subsequently, preliminary impressions were made with an irreversible hydrocolloid impression material.
At the second visit Definitive impressions will be made using auto-polymerizing acrylic resin custom tray. The tray will be traced using low fusing modeling green compound then zinc oxide eugenol impression will be taken. For the fabrication of conventional CDs, the record base will be fabricated with an auto-polymerizing acrylic resin. For the fabrication of digital CDs, the record base will be directly designed on the intraoral scan data by using a CAD software program (Dental System, v1.7.16.0; 3Shape A/S) and will be additively manufactured with a 3D-printing material (Next- Dent C\&B; 3D Systems) and a 3D printer (NextDent 5100; 3D Systems). Following this, a wax occlusal rim were attached to the record base.
At the third visit Maxillo-mandibular relationship were recorded by using the record base and wax occlusal rim assembly with an occlusal relationship registration material for both groups, and appropriate artificial teeth will be selected. For the fabrication of digital CDs, the obtained inter-arch relationship were scanned with the intraoral scanner. Subsequently, the standard tessellation language (STL) files for both edentulous arches and the registered inter-arch relationship will be imported into a metrology software program (Geomagic Control X, v2018.0.1; 3D Systems). The maxillary portion in the STL file of the registered interarch relationship will be flipped normal, creating a new STL file, and the original maxillary edentulous STL file were superimposed over this new flipped file through a best-fit matching algorithm. The same procedure were followed with regard to the mandibular portion in the STL file of the registered inter-arch relationship. This procedure enabled accurate 3D orientation of the obtained intraoral scan data. Next, the border of the CDs will be set 1 mm shorter than the scan border within the CAD software program. The artificial teeth will be arranged virtually, and the trial dentures were additively manufactured with the3D-printing material (NextDent C\&B; 3D Systems) and the 3D printer. For the conventional dentures the artificial teeth were arranged in the conventional manner.
At the fourth visit Trial dentures were evaluated in both groups. The procedure for preparing the definitive CDs were initiated after the participant had accepted the trial dentures. For the fabrication of digital CDs, the gingival portion and the artificial tooth portion were fabricated separately by using the 3D printer and 3D printing materials (NextDent Base and NextDent C\&B; 3D Systems) and were subsequently attached to each other. Conventional CDs were fabricated by using flasking technique with long curing cycle.
At the fifth visit The predetermined CDs type were delivered and will be adjusted and follow up visits will be scheduled.
The participants were randomly allocated into two equal groups (7 per group). An independent examiner using a computer program, specifically Microsoft Excel, will carry out randomization process. The first group of 7 participants were received digital CDs. At 3 months after denture use, the TOMASS test were done. After 1 week washout period, the participants wearied the conventional CDs for an additional 3 months, then the TOMASS test will be repeated. The second group of 7 patients will initially receive conventional CDs. At three months after denture use, the TOMASS test will be done. Then after 1 week washout period the participants will receive the digital CDs, and the test will be repeated after an additional three months of denture use.
Oral processing assessment:
TOMASS test were utilized to assess participants' oral processing during ingestion of solid food. For this study, a commercially available cracker (biscuit) will be used. Participants will be instructed to sit on a chair in upright position and to eat the biscuit comfortably and as quickly as possible. They also will be asked to say their name out loud as it indicates that they had finished the test. Using a video recorder the procedure will be recorded for further analysis.
The recorded videos were then analyzed using the Avidemux 2.6 program to measure the following:
- Swallowing threshold, which is the duration of chewing until the first swallow (determined by the moment of laryngeal elevation)
- The TOMASS test parameters:
- Number of bites: The number of discrete bites taken to finish the cracker
- Number of masticatory cycles: As each cyclical mandibular movement up-down
- Number of swallows: As each vertical movement of the thyroid cartilage
- Total ingestion time: The time taken to complete the ingestion of the cracker from the first bite to the last.
- Conditions
- Swallowing Disorder
- Being tested
- Procedure for construction of complete denture either conventional or fully digital fabrication
- Keywords
- complete denture, Fully digital, Food processing
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure for construction of complete denture either conventional or fully digital fabricationProcedure or surgery
To ensure consistency and minimize patient visits, fabrication of both the conventional and fully digital complete dentures was conducted simultaneously during each clinical stage. All procedures were performed by the same prosthodontist, and efforts were made to standardize materials, occlusal schemes, and vertical dimension across both workflows for each patient.
each patient received two sets of dentures fabricated to identical functional and esthetic specifications, differing only in the manufacturing technique.
| Study group | Role | What they receive |
|---|---|---|
| Conventionally fabricated complete denture | Active comparator | Each patient received two sets of dentures fabricated to identical functional and esthetic specifications, differing only in the manufacturing technique.
The participants received conventional Complete dentures. Three months after denture use, the TOMASS test was done. Receives: Procedure: Procedure for construction of complete denture either conventional or fully digital fabrication |
| Fully digital fabricated complete denture | Active comparator | Each patient received two sets of dentures fabricated to identical functional and esthetic specifications, differing only in the manufacturing technique.
The participants received Fully digital fabricated complete denture. Three months after denture use, the TOMASS test was done. Receives: Procedure: Procedure for construction of complete denture either conventional or fully digital fabrication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallowing threshold
Swallowing threshold, which is the duration of chewing until the first swallow (determined by the moment of laryngeal elevation)
Measured: 3 months after denture use
The TOMASS test parameters: Number of bites:
Number of bites: The number of discrete bites taken to finish the cracker
Measured: 3 months after denture use
Secondary outcomes (3)
Number of masticatory cycles:
Number of masticatory cycles: As each cyclical mandibular movement up-down
Measured: 3 months after denture use
Number of swallows
Number of swallows: As each vertical movement of the thyroid cartilage
Measured: 3 months after denture use
Total ingestion time:
Total ingestion time: The time taken to complete the ingestion of the cracker from the first bite to the last.
Measured: 3 months after denture use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start17 Nov 2024
- Primary completion6 Oct 2025
- Study completion2 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing DisorderStudies 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
- Model description
- This randomized crossover clinical trial evaluated swallowing function using the TOMASS test in patients fitted with 2 types of complete dentures (CDs): Conventionally fabricated CDS and Fully Digital fabricated CDs. Randomization process to participants was done to minimize the impact of the order of denture type on the measurements of swallowing threshold and Oral food processing assessment.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elgamal, Mansoura University
- Investigators
- Mohamed E Elgamal, Principal investigator, Mansoura UniversityAbdallah M Ibrahim, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290933
- Sponsor's protocol ID
- R.25.11.82
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- 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 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Food Processing for Digitally Constructed Complete Dentures Versus Conventional Complete Dentures: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT07290933
- Acronym / sponsor ID
- R.25.11.82
- Conditions
- Swallowing Disorder
- Keywords
- complete denture, Fully digital, Food processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 17 Nov 2024 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 18 Dec 2025 (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 study aimed to compare the effects of fully digital versus conventional complete denture fabrication on oral food processing (mastication and swallowing of solids) in edentulous patients, using the Test of Mastication and Swallowing Solids (TOMASS).
In a randomized crossover study design was carried out on 14 completely edentulous participants (age 50-65 years, both sexes) in good general and oral health, each participants received two sets of dentures: one fabricated with conventional workflow (physical impressions, tooth arrangement, processing into heat polymerized acrylic) and one fully digital workflow (Intra-oral scanning , CAD/CAM design, 3D printed base and teeth,). Each denture was worn for 3 months; with a 2 week "wash out" period between wearing periods, during which participants reverted to their old dentures or no dentures. The order (Conventional complete denture first vs Digital complete denture first) was randomized. At the end of each denture period, Oral food processing performance was measured using TOMASS (solid cracker test): Swallowing threshold and TOMASS test parameters that include number of bites, number of masticatory cycles, number of swallows, and total time (from first bite to last swallow)
Detailed description
Fourteen completely edentulous patients were participated in this study, their ages range from 50- 70 years. The participants were selected from Prosthodontics Department, Faculty of Dentistry, Mansoura University who are seeking for complete denture treatment. All participants will be completely edentulous for at least 6 months and have no previous experience with removable prosthesis. Subjects with temporomandibular joint disorders, head/neck injury, or with skeletal deformity were excluded from this study. All participants were Angel's class I maxillomandibular relation. Informed consent were written from each patient, and approval from the Faculty Ethical Committee will be obtained. The sample size was deter¬mined based on the number of chews for TOMASS test data from previous research. A computer software program (G*power, version 3.1.5, Kiel, Germany) was used for sample size calculation. 14 participants was detected with an effect size of 72%, 5% error probability, and 80% power.
Complete dentures construction:
At the first visit Direct intraoral scanning of both arches were performed with an intraoral scanner (TRIOS 3; 3Shape A/S). Cheek retractors were used to gently extend the movable soft tissues. The ridge crest were scanned first, followed by scans of the labial or buccal and palatal or lingual surfaces of the ridge. For the maxillary arch, the palate were additionally scanned. After establishing the overall contour in this manner, the remaining unscanned parts were scanned to finalize the complete arch scan. Subsequently, preliminary impressions were made with an irreversible hydrocolloid impression material.
At the second visit Definitive impressions will be made using auto-polymerizing acrylic resin custom tray. The tray will be traced using low fusing modeling green compound then zinc oxide eugenol impression will be taken. For the fabrication of conventional CDs, the record base will be fabricated with an auto-polymerizing acrylic resin. For the fabrication of digital CDs, the record base will be directly designed on the intraoral scan data by using a CAD software program (Dental System, v1.7.16.0; 3Shape A/S) and will be additively manufactured with a 3D-printing material (Next- Dent C\&B; 3D Systems) and a 3D printer (NextDent 5100; 3D Systems). Following this, a wax occlusal rim were attached to the record base.
At the third visit Maxillo-mandibular relationship were recorded by using the record base and wax occlusal rim assembly with an occlusal relationship registration material for both groups, and appropriate artificial teeth will be selected. For the fabrication of digital CDs, the obtained inter-arch relationship were scanned with the intraoral scanner. Subsequently, the standard tessellation language (STL) files for both edentulous arches and the registered inter-arch relationship will be imported into a metrology software program (Geomagic Control X, v2018.0.1; 3D Systems). The maxillary portion in the STL file of the registered interarch relationship will be flipped normal, creating a new STL file, and the original maxillary edentulous STL file were superimposed over this new flipped file through a best-fit matching algorithm. The same procedure were followed with regard to the mandibular portion in the STL file of the registered inter-arch relationship. This procedure enabled accurate 3D orientation of the obtained intraoral scan data. Next, the border of the CDs will be set 1 mm shorter than the scan border within the CAD software program. The artificial teeth will be arranged virtually, and the trial dentures were additively manufactured with the3D-printing material (NextDent C\&B; 3D Systems) and the 3D printer. For the conventional dentures the artificial teeth were arranged in the conventional manner.
At the fourth visit Trial dentures were evaluated in both groups. The procedure for preparing the definitive CDs were initiated after the participant had accepted the trial dentures. For the fabrication of digital CDs, the gingival portion and the artificial tooth portion were fabricated separately by using the 3D printer and 3D printing materials (NextDent Base and NextDent C\&B; 3D Systems) and were subsequently attached to each other. Conventional CDs were fabricated by using flasking technique with long curing cycle.
At the fifth visit The predetermined CDs type were delivered and will be adjusted and follow up visits will be scheduled.
The participants were randomly allocated into two equal groups (7 per group). An independent examiner using a computer program, specifically Microsoft Excel, will carry out randomization process. The first group of 7 participants were received digital CDs. At 3 months after denture use, the TOMASS test were done. After 1 week washout period, the participants wearied the conventional CDs for an additional 3 months, then the TOMASS test will be repeated. The second group of 7 patients will initially receive conventional CDs. At three months after denture use, the TOMASS test will be done. Then after 1 week washout period the participants will receive the digital CDs, and the test will be repeated after an additional three months of denture use.
Oral processing assessment:
TOMASS test were utilized to assess participants' oral processing during ingestion of solid food. For this study, a commercially available cracker (biscuit) will be used. Participants will be instructed to sit on a chair in upright position and to eat the biscuit comfortably and as quickly as possible. They also will be asked to say their name out loud as it indicates that they had finished the test. Using a video recorder the procedure will be recorded for further analysis.
The recorded videos were then analyzed using the Avidemux 2.6 program to measure the following:
- Swallowing threshold, which is the duration of chewing until the first swallow (determined by the moment of laryngeal elevation)
- The TOMASS test parameters:
- Number of bites: The number of discrete bites taken to finish the cracker
- Number of masticatory cycles: As each cyclical mandibular movement up-down
- Number of swallows: As each vertical movement of the thyroid cartilage
- Total ingestion time: The time taken to complete the ingestion of the cracker from the first bite to the last.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This randomized crossover clinical trial evaluated swallowing function using the TOMASS test in patients fitted with 2 types of complete dentures (CDs): Conventionally fabricated CDS and Fully Digital fabricated CDs. Randomization process to participants was done to minimize the impact of the order of denture type on the measurements of swallowing threshold and Oral food processing assessment.
| Arm | Type | Receives |
|---|---|---|
| Conventionally fabricated complete denture | Active comparator | Procedure: Procedure for construction of complete denture either conventional or fully digital fabricationEach patient received two sets of dentures fabricated to identical functional and esthetic specifications, differing only in the manufacturing technique. The participants received conventional Complete dentures. Three months after denture use, the TOMASS test was done. |
| Fully digital fabricated complete denture | Active comparator | Procedure: Procedure for construction of complete denture either conventional or fully digital fabricationEach patient received two sets of dentures fabricated to identical functional and esthetic specifications, differing only in the manufacturing technique. The participants received Fully digital fabricated complete denture. Three months after denture use, the TOMASS test was done. |
Who may qualify
- Ages
- 50 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Participants with temporo-mandibular joint disorders.
- head/neck injury, or with skeletal deformity.
- Inability to wear dentures for extended periods or intolerance to the study
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 |
|---|---|---|
| Procedure for construction of complete denture either conventional or fully digital fabricationTo ensure consistency and minimize patient visits, fabrication of both the conventional and fully digital complete dentures was conducted simultaneously during each clinical stage. All procedures were performed by the same prosthodontist, and efforts were made to standardize materials, occlusal schemes, and vertical dimension across both workflows for each patient. each patient received two sets of dentures fabricated to identical functional and esthetic specifications, differing only in the manufacturing technique. | Procedure or surgery | Conventionally fabricated complete denture, Fully digital fabricated complete denture |
Primary outcome
Swallowing threshold
Time frame: 3 months after denture use
Swallowing threshold, which is the duration of chewing until the first swallow (determined by the moment of laryngeal elevation)
The TOMASS test parameters: Number of bites:
Time frame: 3 months after denture use
Number of bites: The number of discrete bites taken to finish the cracker
3 secondary outcomes
Number of masticatory cycles:
Time frame: 3 months after denture use
Number of swallows
Time frame: 3 months after denture use
Total ingestion time:
Time frame: 3 months after denture use
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 18 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Mohamed E Elgamal principal investigator
Mansoura University
Abdallah M Ibrahim study director
Mansoura 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 Procedure for construction of complete denture either conventional or fully digital fabrication in people with Swallowing Disorder, run by Mansoura 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 0 inclusion and 3 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 18 Dec 2025. 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?
Swallowing threshold (time frame: 3 months after denture use). 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 18 Dec 2025.