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15 Patients requiring complete dentures will be recruited from Dubai Health. Each patient will receive two sets of dentures with a washout period between sets. Patients will remain blinded to the fabrication method used for each set.
To ensure randomization and reduce order effects, participants will be randomly assigned to Group 1 or Group 2 using a stratified randomization approach in Microsoft Excel. A computer-generated random number will determine group allocation, ensuring that both groups have a balanced distribution based on age, gender, and oral health status. The randomization process will assign participants to either receive conventional dentures first (Group 1) or digital dentures first (Group 2), with a washout period between treatments. By randomizing the sequence of denture delivery, this method will control for potential biases in patient-reported outcomes (OHIP-14, DSQ) and clinical assessments, ensuring that the order of treatment does not influence the study results.
The following outcomes will be analysed:
The secondary outcomes include:
Cost-effectiveness ratio = Total cost per patient / OHIP-14 improvement score Benchmark = Cost per point × 5 This model provides a practical and meaningful way to interpret cost relative to patient-perceived improvement, supporting decisions on the integration of digital denture workflows.
The factors will be analyzed through a combination of validated patient-reported outcome measures, digital and conventional assessment techniques, and cost-effectiveness evaluations. Quality of life (QOL) will be assessed using the Oral Health Impact Profile (OHIP-14), a validated measure of oral health-related quality of life, while patient-reported outcomes (PROMS) will be evaluated using the Denture Satisfaction Questionnaire (DSQ) to assess patient satisfaction with comfort, aesthetics, speech, and function of conventional and digital dentures. Occlusal analysis will be conducted using both conventional and digital methods. Articulating paper will be used to assess occlusal contact number and occlusal contact area through visual inspection, while T-Scan and Modjaw will provide quantitative measurements of occlusal force distribution and balance between conventional and digitally fabricated dentures.
Cost, time efficiency, and accuracy will be compared between fabrication techniques. The total number of clinical visits and time spent on clinical and laboratory procedures will be recorded to determine workflow efficiency. A comparative cost analysis will evaluate direct expenses (materials, fabrication) and indirect costs (adjustments, remakes). Denture accuracy will be assessed through 3D scanning and superimposition analysis using Geomagic Control X software, quantifying deviations between the designed and fabricated dentures. Additionally, the fit, retention, and stability of the dentures will be evaluated using a standardized clinical grading scale. Additionally, Accuracy is defined as "the degree to which the result of a measurement, calculation, or specification conforms to the correct value or a standard" . In this study, accuracy pertains to how closely the fabricated complete dentures whether produced via digital or conventional methods match their intended designs and clinical specifications.
To evaluate this:
By employing these standardized digital superimposition techniques, the study ensures a consistent and objective assessment of denture accuracy across both fabrication workflows, encompassing both the overall fit and occlusal parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Dentures | Other | Participants will first receive conventionally fabricated dentures for both the upper and lower jaws. This set will be made using traditional techniques, including impressions, a custom tray, jaw relation recording, try-in, and final fitting. After the washout period, they will receive a second set created with the 3D-printed technique. |
|
| Digital Dentures | Other | Complete dentures fabricated with digital workflow, including intraoral scanning, CAD/CAM design, and 3D printing, followed by clinical fitting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Occlusal Analysis Device | Device | Computerized occlusal analysis performed using T-Scan and ModJaw devices to record occlusal contacts, timing, and force distribution during prosthesis fitting and function. |
| Measure | Description | Time Frame |
|---|---|---|
| Occlusal Force Distribution and Contact Accuracy | Quantitative assessment of occlusal contact number, area, timing, and force distribution in digital versus conventional complete dentures, measured using T-Scan and ModJaw systems, and validated against articulating paper marks. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Oral Health-Related Quality of Life (OHRQoL) | Change in Oral Health Impact Profile (OHIP-14) total scores between digital and conventional dentures, reflecting impact on comfort, function, and psychosocial well-being. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Time Efficiency | Mean chairside time (in minutes) required for each clinical step, including impressions, jaw relation recording, try-in, and final insertion. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| May Al Janahi, Dclident | Contact | +971507190034 | may.aljanahi@dubaihealth.ae | |
| Haitham Elbishari, PhD | Contact | +9714383 | 8911 | helbishari@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Haitham Elbishari, PhD | MBRU | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32940594 | Background | McKenna G, Tsakos G, Burke F, Brocklehurst P. Managing an Ageing Population: Challenging Oral Epidemiology. Prim Dent J. 2020 Sep;9(3):14-17. doi: 10.1177/2050168420943063. | |
| 24446979 | Background | Muller F. Interventions for edentate elders--what is the evidence? Gerodontology. 2014 Feb;31 Suppl 1:44-51. doi: 10.1111/ger.12083. |
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confidentiality
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| ID | Term |
|---|---|
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
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| 22439094 | Background | Qadeer S, Kerstein R, Kim RJ, Huh JB, Shin SW. Relationship between articulation paper mark size and percentage of force measured with computerized occlusal analysis. J Adv Prosthodont. 2012 Feb;4(1):7-12. doi: 10.4047/jap.2012.4.1.7. Epub 2012 Feb 29. |
| 21050499 | Background | Gerritsen AE, Allen PF, Witter DJ, Bronkhorst EM, Creugers NH. Tooth loss and oral health-related quality of life: a systematic review and meta-analysis. Health Qual Life Outcomes. 2010 Nov 5;8:126. doi: 10.1186/1477-7525-8-126. |