EdentulismNCT07579377
The Effect of Palatal Rugae Design in Complete Denture on Patient Satisfaction and Quality of Life
A study testing Polished Palatal Surface Denture, Roughened Palatal Rugae Design and Vacuum-Formed Thermoplastic Sheet Rugae Denture in people with Edentulism and Complete Dentures, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn whether different palatal rugae designs in complete dentures can improve comfort, function, and overall oral health-related quality of life in edentulous adults aged 40 to 80 years. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulism, Complete Dentures
- What is being tested?
- Polished Palatal Surface Denture, Roughened Palatal Rugae Design and Vacuum-Formed Thermoplastic Sheet Rugae Denture
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Oct 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients seeking conventional complete dentures.
- Aged 40-80 years.
- Both genders (male and female).
- Patient's must be willing to participate in the study and able to attend follow-up appointments
Who cannot join
- Patients with severe underlying medical conditions and mental conditions.
- Neuromuscular dysfunction.
- Oral diseases such as denture stomatitis and oral submucous fibrosis
- Xerostomia and tied tongue condition.
- Flabby and Atrophic Ridges.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Dow University of Health Sciences, Karachi
Karachi, Sindh, 75500
Aqsa s Aqsa Saeed Khan, BDS, aqsasaeedkhan5@gmail.com ext. 0330-8170509, aqsasaeedkhan5@gmail.com
Aqsa saeed Aqsa Saeed Khan, bds
About this study
The goal of this clinical trial is to learn whether different palatal rugae designs in complete dentures can improve comfort, function, and overall oral health-related quality of life in edentulous adults aged 40 to 80 years. The main questions it aims to answer are:
Do roughened or vacuum-formed thermoplastic sheet palatal rugae designs lead to higher patient satisfaction than the traditional polished design?
Read more
Do these designs improve oral health-related quality of life, including chewing, speaking, and overall comfort?
Researchers will compare three denture designs-a polished palatal surface, a roughened palatal surface, and a vacuum-formed thermoplastic sheet rugae design-to see which design provides better comfort, function, and quality of life for patients.
Participants will:
Receive complete maxillary dentures made with one of the three palatal rugae designs
Attend follow-up assessments at 1 week, 1 month, and 3 months after denture insertion (in person or by phone)
Complete the OHIP-EDENT questionnaire and a Visual Analog Scale (VAS) to report satisfaction, comfort, and oral health-related quality of life.
Read the detailed description
Edentulism, the complete loss of natural teeth, remains a significant public health concern due to its profound impact on oral function, speech, comfort, and psychosocial well-being. Although dental implants provide a favorable treatment option for many edentulous patients, financial limitations, medical contraindications, and inadequate bone structure often prevent their use. Consequently, conventional complete dentures continue to serve as the primary option for oral rehabilitation in a large proportion of patients.
In conventional maxillary complete dentures, the palatal surface plays an essential role in retention, support, and stability. However, full palatal coverage may also reduce tactile sensitivity and compromise patient comfort, speech clarity, and the ability to perceive taste and temperature. The natural palate contains palatal rugae-elevated folds rich in mechanoreceptors that contribute to oral proprioception and assist in guiding tongue movements during speech, swallowing, and mastication. In contrast, the palatal surface of a conventional denture is typically smooth, which may limit the tongue's ability to adapt effectively to the prosthesis.
Multiple techniques have been proposed to incorporate palatal rugae patterns into complete dentures, including tin-foil duplication, dental floss carving, silicone putty impressions, small palatal windows, roughening procedures, and vacuum-formed templates. While each method offers certain benefits, they also present limitations such as material instability, operator sensitivity, cost, or the need for additional laboratory steps. Previous research comparing polished, roughened, and open rugae designs has shown that designs with greater tactile feedback may improve user satisfaction and oral health-related quality of life (OHRQoL), whereas excessive modification-such as open rugae windows-may reduce comfort and function. Despite these findings, limited evidence is available regarding the comparative effectiveness of polished, roughened, and vacuum-formed thermoplastic rugae designs in maxillary complete dentures.
This randomized controlled trial aims to address this gap by evaluating how three different palatal rugae textures-polished, roughened, and vacuum-formed thermoplastic sheet-affect patient satisfaction and OHRQoL among complete denture wearers. Ninety participants will be randomly allocated into one of three groups. All dentures will be fabricated using standard clinical and laboratory protocols, with the only experimental variation occurring in the palatal rugae region.
The polished-surface group will receive dentures with a conventional smooth palatal surface finished with standard pumice polishing. The roughened-surface group will receive dentures in which the rugae area is textured using 120-µm aluminum oxide sandblasting at 2 bar for 10 seconds. The vacuum-formed group will receive dentures incorporating a rugae pattern created from a 0.5-mm thermoplastic sheet molded over a cast and transferred to the waxed denture before processing. These three designs represent accessible, commonly used techniques with potential clinical benefits in recreating natural palatal anatomy.
Participants will be evaluated at one week, one month, and three months after denture insertion. During each follow-up, participants will complete the OHIP-EDENT questionnaire to assess the impact of the denture on daily function, psychosocial well-being, and oral discomfort. A Visual Analog Scale (VAS) will also be used to measure subjective satisfaction with comfort, chewing, speech, esthetics, and overall denture experience. Clinical assessments will include denture fit, speech clarity, comfort, mucosal condition, and any necessary adjustments.
The primary outcome of the study is the difference in OHIP-EDENT scores among the three rugae design groups over time. Secondary outcomes include VAS-based satisfaction scores and patient-reported ease of adaptation. Through this structured comparison, the study aims to determine whether incorporating specific palatal rugae textures can improve comfort, enhance sensory feedback, aid speech articulation, and contribute positively to oral health-related quality of life.
Ultimately, this research seeks to inform evidence-based improvements in complete denture design, offering clinicians practical guidance for selecting palatal rugae configurations that enhance patient experience and long-term adaptation.
- Conditions
- Edentulism, Complete Dentures
- Being tested
- Polished Palatal Surface Denture, Roughened Palatal Rugae Design, Vacuum-Formed Thermoplastic Sheet Rugae Denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polished Palatal Surface DentureDevice
Maxillary complete denture with a traditional polished palatal surface. Fabricated using standard clinical procedures without added rugae or texturing. Serves as the control design in this study and will be compared with roughened and vacuum-formed thermoplastic sheet dentures to assess patient satisfaction, comfort, chewing ability, and oral health-related quality of life.
Roughened Palatal Rugae DesignDevice
Maxillary complete denture with a roughened palatal rugae surface. Rugae are intentionally textured to enhance tactile feedback, retention, and comfort. Standard fabrication and fitting procedures are used. Compared with polished and vacuum-formed dentures to evaluate effects on patient satisfaction, comfort, chewing efficiency, and oral health-related quality of life.
Vacuum-Formed Thermoplastic Sheet Rugae DentureDevice
Maxillary complete denture with vacuum-formed thermoplastic sheet palatal rugae. The thermoplastic sheet replicates natural palatal rugae patterns to improve denture retention, comfort, and chewing efficiency. Participants receive standard denture fabrication and fitting. Compared with polished and roughened dentures to assess patient satisfaction, comfort, and oral health-related quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Polished Palatal Surface Denture | Experimental | Maxillary complete denture with a polished palatal surface. The denture is fabricated using standard clinical procedures without added rugae or texturing. This design is being compared with dentures having roughened palatal rugae or vacuum-formed thermoplastic sheet rugae to evaluate differences in patient satisfaction and oral health-related quality of life. Receives: Device: Polished Palatal Surface Denture |
| Arm 2: Roughened Palatal Rugae Design | Experimental | Maxillary complete denture with a roughened palatal rugae surface. The rugae are intentionally textured to improve tactile feedback, retention, and comfort. Participants receive standard denture fabrication and fitting procedures. This intervention is compared with polished and vacuum-formed thermoplastic sheet dentures to assess effects on patient satisfaction and oral health-related quality of life. Receives: Device: Roughened Palatal Rugae Design |
| Arm 3: Vacuum-Formed Thermoplastic Rugae Denture | Experimental | Maxillary complete denture with vacuum-formed thermoplastic sheet palatal rugae. The thermoplastic sheet replicates natural palatal rugae patterns, aiming to enhance denture retention, comfort, and chewing efficiency. Participants receive standard denture fabrication and fitting procedures. This intervention is compared with polished and roughened rugae dentures to evaluate patient satisfaction and oral health-related quality of life. Receives: Device: Vacuum-Formed Thermoplastic Sheet Rugae Denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction measured by Visual Analog Scale (VAS) at 3 months after insertion of complete dentures
Patient satisfaction with maxillary complete dentures assessed using a Visual Analog Scale (VAS). Participants rate their overall satisfaction on a 100-mm line, where 0 indicates "not satisfied" and 100 indicates "totally satisfied." Higher scores indicate greater satisfaction.
Measured: From enrolment to the end of treatment at 1 week, 3 weeks, 3 months
Secondary outcomes (1)
Oral health-related quality of life measured by OHIP-EDENT score at 3 months after insertion of complete dentures with different palatal rugae designs.
Oral health-related quality of life will be assessed using the 20-item OHIP-EDENT questionnaire at 3 months post-insertion of complete dentures with polished, roughened, or vacuum-formed palatal rugae designs. Scores will range from 20 (best) to 100 (worst), with lower scores indicating better quality of life. This measure will evaluate the impact of different palatal rugae textures on patients' comfort, function, and overall oral health-related quality of life over time
Measured: From enrolment to the end of treatment at 1 week, 3 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start20 Oct 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of three parallel groups, each receiving a maxillary complete denture with a different palatal rugae surface design (polished surface, roughened surface, or vacuum-formed thermoplastic rugae). Participants remain in their assigned group throughout the study, and outcomes are compared between groups over a three-month follow-up period.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579377
- Sponsor's protocol ID
- 65310
- Status last verified
- Oct 2025
- First submitted
- 7 Jan 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Palatal Rugae Design in Complete Denture on Patient Satisfaction and Quality of Life
- ClinicalTrials.gov ID
- NCT07579377
- Acronym / sponsor ID
- 65310
- Conditions
- Edentulism, Complete Dentures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 May 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.
The goal of this clinical trial is to learn whether different palatal rugae designs in complete dentures can improve comfort, function, and overall oral health-related quality of life in edentulous adults aged 40 to 80 years. The main questions it aims to answer are:
Do roughened or vacuum-formed thermoplastic sheet palatal rugae designs lead to higher patient satisfaction than the traditional polished design?
Do these designs improve oral health-related quality of life, including chewing, speaking, and overall comfort?
Researchers will compare three denture designs-a polished palatal surface, a roughened palatal surface, and a vacuum-formed thermoplastic sheet rugae design-to see which design provides better comfort, function, and quality of life for patients.
Participants will:
Receive complete maxillary dentures made with one of the three palatal rugae designs
Attend follow-up assessments at 1 week, 1 month, and 3 months after denture insertion (in person or by phone)
Complete the OHIP-EDENT questionnaire and a Visual Analog Scale (VAS) to report satisfaction, comfort, and oral health-related quality of life.
Detailed description
Edentulism, the complete loss of natural teeth, remains a significant public health concern due to its profound impact on oral function, speech, comfort, and psychosocial well-being. Although dental implants provide a favorable treatment option for many edentulous patients, financial limitations, medical contraindications, and inadequate bone structure often prevent their use. Consequently, conventional complete dentures continue to serve as the primary option for oral rehabilitation in a large proportion of patients.
In conventional maxillary complete dentures, the palatal surface plays an essential role in retention, support, and stability. However, full palatal coverage may also reduce tactile sensitivity and compromise patient comfort, speech clarity, and the ability to perceive taste and temperature. The natural palate contains palatal rugae-elevated folds rich in mechanoreceptors that contribute to oral proprioception and assist in guiding tongue movements during speech, swallowing, and mastication. In contrast, the palatal surface of a conventional denture is typically smooth, which may limit the tongue's ability to adapt effectively to the prosthesis.
Multiple techniques have been proposed to incorporate palatal rugae patterns into complete dentures, including tin-foil duplication, dental floss carving, silicone putty impressions, small palatal windows, roughening procedures, and vacuum-formed templates. While each method offers certain benefits, they also present limitations such as material instability, operator sensitivity, cost, or the need for additional laboratory steps. Previous research comparing polished, roughened, and open rugae designs has shown that designs with greater tactile feedback may improve user satisfaction and oral health-related quality of life (OHRQoL), whereas excessive modification-such as open rugae windows-may reduce comfort and function. Despite these findings, limited evidence is available regarding the comparative effectiveness of polished, roughened, and vacuum-formed thermoplastic rugae designs in maxillary complete dentures.
This randomized controlled trial aims to address this gap by evaluating how three different palatal rugae textures-polished, roughened, and vacuum-formed thermoplastic sheet-affect patient satisfaction and OHRQoL among complete denture wearers. Ninety participants will be randomly allocated into one of three groups. All dentures will be fabricated using standard clinical and laboratory protocols, with the only experimental variation occurring in the palatal rugae region.
The polished-surface group will receive dentures with a conventional smooth palatal surface finished with standard pumice polishing. The roughened-surface group will receive dentures in which the rugae area is textured using 120-µm aluminum oxide sandblasting at 2 bar for 10 seconds. The vacuum-formed group will receive dentures incorporating a rugae pattern created from a 0.5-mm thermoplastic sheet molded over a cast and transferred to the waxed denture before processing. These three designs represent accessible, commonly used techniques with potential clinical benefits in recreating natural palatal anatomy.
Participants will be evaluated at one week, one month, and three months after denture insertion. During each follow-up, participants will complete the OHIP-EDENT questionnaire to assess the impact of the denture on daily function, psychosocial well-being, and oral discomfort. A Visual Analog Scale (VAS) will also be used to measure subjective satisfaction with comfort, chewing, speech, esthetics, and overall denture experience. Clinical assessments will include denture fit, speech clarity, comfort, mucosal condition, and any necessary adjustments.
The primary outcome of the study is the difference in OHIP-EDENT scores among the three rugae design groups over time. Secondary outcomes include VAS-based satisfaction scores and patient-reported ease of adaptation. Through this structured comparison, the study aims to determine whether incorporating specific palatal rugae textures can improve comfort, enhance sensory feedback, aid speech articulation, and contribute positively to oral health-related quality of life.
Ultimately, this research seeks to inform evidence-based improvements in complete denture design, offering clinicians practical guidance for selecting palatal rugae configurations that enhance patient experience and long-term adaptation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to one of three parallel groups, each receiving a maxillary complete denture with a different palatal rugae surface design (polished surface, roughened surface, or vacuum-formed thermoplastic rugae). Participants remain in their assigned group throughout the study, and outcomes are compared between groups over a three-month follow-up period.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Polished Palatal Surface Denture | Experimental | Device: Polished Palatal Surface DentureMaxillary complete denture with a polished palatal surface. The denture is fabricated using standard clinical procedures without added rugae or texturing. This design is being compared with dentures having roughened palatal rugae or vacuum-formed thermoplastic sheet rugae to evaluate differences in patient satisfaction and oral health-related quality of life. |
| Arm 2: Roughened Palatal Rugae Design | Experimental | Device: Roughened Palatal Rugae DesignMaxillary complete denture with a roughened palatal rugae surface. The rugae are intentionally textured to improve tactile feedback, retention, and comfort. Participants receive standard denture fabrication and fitting procedures. This intervention is compared with polished and vacuum-formed thermoplastic sheet dentures to assess effects on patient satisfaction and oral health-related quality of life. |
| Arm 3: Vacuum-Formed Thermoplastic Rugae Denture | Experimental | Device: Vacuum-Formed Thermoplastic Sheet Rugae DentureMaxillary complete denture with vacuum-formed thermoplastic sheet palatal rugae. The thermoplastic sheet replicates natural palatal rugae patterns, aiming to enhance denture retention, comfort, and chewing efficiency. Participants receive standard denture fabrication and fitting procedures. This intervention is compared with polished and roughened rugae dentures to evaluate patient satisfaction and oral health-related quality of life. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients seeking conventional complete dentures.
- Aged 40-80 years.
- Both genders (male and female).
- Patient's must be willing to participate in the study and able to attend follow-up appointments
Key exclusion criteria (5 listed)
- Patients with severe underlying medical conditions and mental conditions.
- Neuromuscular dysfunction.
- Oral diseases such as denture stomatitis and oral submucous fibrosis
- Xerostomia and tied tongue condition.
- Flabby and Atrophic Ridges.
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 |
|---|---|---|
| Polished Palatal Surface DentureMaxillary complete denture with a traditional polished palatal surface. Fabricated using standard clinical procedures without added rugae or texturing. Serves as the control design in this study and will be compared with roughened and vacuum-formed thermoplastic sheet dentures to assess patient satisfaction, comfort, chewing ability, and oral health-related quality of life. | Device | Arm 1: Polished Palatal Surface Denture |
| Roughened Palatal Rugae DesignMaxillary complete denture with a roughened palatal rugae surface. Rugae are intentionally textured to enhance tactile feedback, retention, and comfort. Standard fabrication and fitting procedures are used. Compared with polished and vacuum-formed dentures to evaluate effects on patient satisfaction, comfort, chewing efficiency, and oral health-related quality of life. | Device | Arm 2: Roughened Palatal Rugae Design |
| Vacuum-Formed Thermoplastic Sheet Rugae DentureMaxillary complete denture with vacuum-formed thermoplastic sheet palatal rugae. The thermoplastic sheet replicates natural palatal rugae patterns to improve denture retention, comfort, and chewing efficiency. Participants receive standard denture fabrication and fitting. Compared with polished and roughened dentures to assess patient satisfaction, comfort, and oral health-related quality of life. | Device | Arm 3: Vacuum-Formed Thermoplastic Rugae Denture |
Primary outcome
Patient satisfaction measured by Visual Analog Scale (VAS) at 3 months after insertion of complete dentures
Time frame: From enrolment to the end of treatment at 1 week, 3 weeks, 3 months
Patient satisfaction with maxillary complete dentures assessed using a Visual Analog Scale (VAS). Participants rate their overall satisfaction on a 100-mm line, where 0 indicates "not satisfied" and 100 indicates "totally satisfied." Higher scores indicate greater satisfaction.
1 secondary outcome
Oral health-related quality of life measured by OHIP-EDENT score at 3 months after insertion of complete dentures with different palatal rugae designs.
Time frame: From enrolment to the end of treatment at 1 week, 3 weeks, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- 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.
Dow University of Health Sciences, Karachi
Karachi, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polished Palatal Surface Denture, Roughened Palatal Rugae Design and Vacuum-Formed Thermoplastic Sheet Rugae Denture in people with Edentulism and Complete Dentures, run by Dow University of Health Sciences at 1 site in Pakistan.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 May 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction measured by Visual Analog Scale (VAS) at 3 months after insertion of complete dentures (time frame: From enrolment to the end of treatment at 1 week, 3 weeks, 3 months). 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 12 May 2026.